If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, acute hepatic failure or acute liver failure, please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help.

Sanofi-Aventis Sends Warning Letter on Multaq Liver Failures

Pharmaceutical giant Sanofi-Aventis SA sent a letter to doctors in the US in January 2011, alerting them to recent findings showing that their heart drug, Multaq had been linked to multiple cases of acute liver failure. These documented cases of Multaq related liver failure were of a nature so severe, as to require liver transplants to save the lives of those Multaq patients cited in the warning letter from Sanofi.

In the letter, France’s largest drugmaker, Sanofi-Aventis SA, informed doctors about liver function test results and injuries involving toxicity reported by patients treated with Sanofi’s Multaq, including two cases of acute liver failure, a company spokesman said. Sanofi-Aventis SA currently denies a causal relationship between Multaq and liver toxicity and failure. 

During the past 60 days, Sanofi-Aventis SA has been issued two Official Warning Letters from the FDA regarding related violations.  One warning letter from the FDA was issued regarding violations in manufacturing processes at the Sanofi-Aventis manufacturing facility, and one dated January 28, 2011 specifically dealing with violations in their reporting of adverse reactions to their drugs.  The drug Multaq was one of the specific drugs cited in this FDA Warning letter to Sanofi regarding their violation in the reporting of adverse effects.  Sources have stated that the severe adverse effects of Multaq related liver complications have been downplayed.

According to Sanofi, almost 200,000 patients worldwide have been prescribed Multaq since it was first approved and introduced in 2009. Sanofi was hoping that sales of Multaq would help offset losses in revenue resulting from products, including the blood-thinner Plavix and the cancer treatment Taxotere, facing stiff competition from generic drugs. Bloomberg analysts projected that Sanofi-Aventis’ revenues from Multaq would reach $1.1 billion by 2013.

Speaking of the latest liver failure news from Sanofi,  “Multaq will be an important drug over the next 10 years” for Sanofi and the treatment “cannot afford to face serious side effects that are tough to resolve,” Eric Le Berrigaud, an analyst at Raymond James in Paris, wrote in note to clients in January.

Multaq was approved by the FDA for sale in the US in 2009.  Multaq is designed to treat atrial fibrillation, which is an irregular and/or rapid beating in the upper chambers of the heart. According to the National Heart, Lung and Blood Institute, atrial fibrillation affects an estimated 2 million people in the U.S.

In an FDA Statement, Multaq was tied to acute liver failure, requiring  liver transplants, in two women.  The U.S. Food and Drug Administration published this notice on its website.  According to the FDA, Sanofi has said that it will provide additional information about liver risks associated with Multaq to the “warnings and precautions” and “adverse reactions” sections of its Multaq prescribing information.

Sanofi reports that it is working closely with the European Medicines Agency in London and other health authorities to review this matter.

Multaq sales in the U.S. reached $115 million during the first three quarters of 2010, according to a company report published on Oct. 28, 2010.  These results were a disappointment according to some analysts, who say it as lagging behind expectations for the drug.

One financial analyst speculated that Multaq’s struggle to penetrate the U.S. market is not expected to benefit from this bad news related to multiple cases of acute liver failure, involving liver transplants.

Multaq was originally designed to be a safer alternative to the drug amiodarone, a generic medicine with serious liver and lung risks that is currently only approved for life-threatening irregular beating in the heart’s lower chambers. “Amiodarone includes a black box label citing various toxicities including severe liver toxicity,” wrote Seamus Fernandez, an analyst with Leerink Swann Research, in a note to investors.

Recently, Sanofi and U.S. partner Bristol-Myers Squibb Co. voluntarily recalled 64 million tablets of their Avalide blood pressure drug due to other safety concerns.

Multaq Class Action Lawsuit vs. Individual Multaq Lawsuit

There are strong differences between a class action lawsuit and an individual lawsuit. In the case of Multaq, a Multaq liver failure class action lawsuit would be a form of Multaq lawsuit in which a large group of plaintiffs would form a “class” and collectively bring a lawsuit to court against a defendant, which in this case would be Sanofi-Aventis, the manufacturer of Multaq. In a class action lawsuit involving personal injury from defective drugs like Multaq, all potential Multaq liver failure lawsuit plaintiffs would be grouped into a single Multaq liver failure class action lawsuit.  This grouping into a class would happen regardless of degree or severity of liver toxicity injuries.

In a Multaq liver failure class action lawsuit, plaintiffs with injuries from minor ones all the way to the most severe acute liver failure toxicity cases requiring a complete liver transplant, would be grouped into one single Multaq class action lawsuit. Plaintiffs in this class would share any award or settlement resulting from the Multaq liver failure class action lawsuit.

Multaq liver failure lawsuits involving catastrophic injury or death would in most cases be better served by an individual lawsuit.  Because of the severity and degree of injury to the plaintiff by Multaq, an individual lawsuit would be in the plaintiff’s best interest . Dangerous drugs like Multaq have been linked to severe liver injuries, including acute liver failure, which often times requires surgery and extensive medical care.  In an individual Multaq acute hepatic failure lawsuit, each plaintiff’s case is filed, presented and considered individually, on a case by case basis, solely on its own strength and degree of  liver toxicity injury.

In many cases involving Multaq, surgery is required. An individual Multaq liver failure lawsuit allows each Multaq liver failure victim to be thoroughly considered on an individual basis when determining damages, awards and potential settlement amounts, based on their own toxicity injuries and future needs, and not as part of a grouped class action lawsuit.

Speak to a Multaq Lawyer about a Multaq Liver Failure Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, acute liver failure or acute hepatic failure please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Multaq, but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of this dangerous drug. You are not alone. Join other liver failure victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, acute hepatic failure or acute liver failure, please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. Please fill out our free online legal evaluation form on the right side of this page and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help.

FDA Warns Sanofi For Failing To Report Side Effects

In a harsh warning letter, the FDA has reprimanded Sanofi-Aventis for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill, and also did not report post-marketing studies or completed, unpublished clinical trials in NDA annual reports. The seven-page missive, which was dated January 28, comes after the agency reviewed Sanofi paperwork last May. And a separate letter dated February 9 notes that a Sanofi plant in Germany has problems with contamination.

When it came to reporting adverse events, however, some reporting delays stretched back as far as 2007 – there was a delay of 896 days in reporting side effects associated with the Glyburide diabetes med. Other delays were not quite as lengthy – Sanofi waited only 30 days to report adverse events concerning its Amaryl diabetes drug. But even 30 days is too long. Here’s why…

Federal law requires that adverse drug reports that are both serious and unexpected must be filed with the FDA within 15 calendar days of initial receipt. Overall, the FDA counted 185 initial 15-day reports were submitted late between January 1, 2009 and March 31, 2010. There were also 127 follow-up, or post-marketing adverse event, reports that were submitted late during the same period.

The FDA then writes that Sanofi’s standard operating procedure for gathering reports “fails to provide written adverse drug experience definitions required to assess and evaluate adverse drug experiences” for submitting individual safety reports, including those required to be reported within 15 days. And the “Adverse Event Reporting Form” used by call center contractors for noting adverse reports do not correctly identify adverse outcomes required to determine the seriousness of an adverse event.

How could this happen? As Pfizer did last June when confronted with the same problem, Sanofi blamed computer problems, according to the FDA letter. The agency, however, continues to identify issues, such as a lack of training for the support, incomplete SOPs and work instructions, and inaccurate record keeping of older adverse events. And the system “does not display accurate clock dates on MedWatch forms for cases which were initially entered…” As they say, timing is everything.

To cope, Sanofi previously wrote the FDA that the Accenture consulting firm was retained to resolve the computer problems. But the FDA wants to see results. “To date, however, we have not received any response from you indicating that you or your contractor has evaluated or determines the root cause of these issues, or taken steps to resolve them or re-validate your computer system to correct deficiencies,” the agency writes.

Meanwhile, the agency was also incensed that Sanofi failed to include all other post-marketing studies in NDA annual reports for three drugs – Apidra, Eloxatin and Ketek – and did not include summaries of completed, unpublished clinical trials. The drugmaker had previously told the FDA that, in March 2008, it would start including foreign clinical trials in its database for NDA annual reports.

“Yet, information obtained during the inspection…indicates that your firm has still failed to report on the status of certain foreign post-marketing clinical trials or studies. Moreover, we are troubled that your firm did not disclose to FDA, until the 2010 inspection, that it did not report on foreign trial or studies prior to 2008,” the FDA letter states. The agency then writes that the “corrective and preventive action plan and the revised NDA annual reports…are still inadequate.”

The February 9 letter takes Sanofi to task for failing to maintain Good Manufacturing Practices at its facility in Frankfurt, where the drugmaker failed to identify the organisms recovered from a sterility test for the Apidra insulin treatment and “failed to keep written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.” Last September, for instance, personnel “involved in the cleaning operations and aseptic connections during filling, were observed demonstrating incorrect aseptic techniques to prevent product contamination”.

In response to warning letter about adverse events, a Sanofi spokesman sends us this statement: “Patient safety is our highest priority at sanofi-aventis U.S. and we are committed to the ongoing comprehensive understanding and communication of the safety of our products. We work globally to collect, evaluate, and process all adverse events received and report them to the FDA and other regulatory authorities throughout the world within rigid time-lines. We acknowledge the FDA’s observations and accept that we can and must strengthen procedures and systems for reporting. Sanofi-Aventis is already working to address these observations and will continue to work with the FDA to ensure compliance with all reporting requirements.”

Sanofi Multaq Class Action Lawsuit vs. Individual Multaq Lawsuit

There are distinct differences between a Multaq (dronedarone) liver failure class action lawsuit and a more typical individual Multaq liver failure lawsuit. A Multaq liver failure class action lawsuit would be a form of Multaq liver failure lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against Sanofi-Aventis, the manufacturer of Multaq, (defendant). In a class action lawsuit involving personal injury, resulting from defective products such as drugs like Multaq (dronedarone), all Multaq liver failure lawsuit plaintiffs would typically be grouped together into a single Multaq liver failure class action lawsuit, regardless of the degree or severity of their liver toxicity injuries. In this type of Multaq liver failure class action lawsuit, plaintiffs with injuries ranging from minor ones not requiring surgery, all the way to the most severe acute liver failure toxicity sides effects, requiring multiple surgeries or a complete liver transplant, would be grouped into one single Multaq liver failure class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the Multaq liver failure class action lawsuit.

In Multaq liver failure lawsuits involving catastrophic injury such as liver toxicity, acute hepatic failure, liver failure or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Drugs like Multaq have been linked to severe liver injuries, including: Liver Toxicity, Liver Failure and Acute Liver Failure. Multaq liver failure toxicity cases such as these are better suited to an individual Multaq liver failure lawsuit because of the severity and degree of injury to the plaintiff. In an individual Multaq liver failure lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of the liver toxicity injury.

In many cases involving Multaq and the serious liver toxicity failures and injuries related to this drug, surgery is often required. In many cases, with surgery and proper medical care, an individual may be able to lead a mostly normal and productive life. An individual Multaq liver failure lawsuit allows each Multaq liver failure victim, their toxicity injuries and their future needs to be thoroughly considered on an individual basis when determining damages, awards and potential settlement amounts, and not as part of a class action lawsuit.

Speak to a Multaq Lawyer about a Multaq Liver Failure Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced acute hepatic failure, liver toxicity or acute liver failure, please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Multaq, but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of this dangerous drug. You are not alone. Join other liver failure victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

FDA Drug Safety Communication:

Severe liver injury associated with the use of dronedarone (marketed as Multaq)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals

Data Summary

Safety Announcement

[1-14-2011] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq).

Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Dronedarone (Multaq) can reduce the risk of being hospitalized for these heart problems. Since dronedarone’s (Multaq) approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.1 Additional usage can occur in the hospital setting.

Dronedarone (Multaq) was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.

Information about the potential risk of liver injury from dronedarone (Multaq) is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

Today’s communication is in keeping with FDA’s commitment to inform the public about its ongoing safety review of drugs. FDA is continuing to review reports of possible adverse events and drug interactions with dronaderone submitted to our Adverse Event Reporting System.

Additional Information for Patients:

• Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
• Talk to your healthcare professional about any concerns you have with this medication.
• Do not stop taking dronedarone unless told to do so by your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.
• Read the Medication Guide when picking up a prescription for dronedarone. It will help you understand the potential risks and benefits of this medication.

Additional Information for HCPs:

Advise patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching) while taking dronedarone.

Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. However, it is not known whether routine periodic monitoring of serum liver enzymes (ALT, AST, and alkaline phosphatase) and bilirubin in patients taking dronedarone (Multaq) will prevent the development of severe liver injury.

If hepatic injury is suspected, dronedarone should be promptly discontinued and testing of serum liver enzymes and bilirubin should be performed. If hepatic injury is found, appropriate treatment should be initiated.

Dronedarone should not be restarted in patients who experience hepatic injury without another explanation for the observed liver injury.

Report adverse events involving dronedarone to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

FDA has received several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The two cases of acute hepatic failure requiring transplantation occurred at 4.5 and 6 months after initiation of dronedarone (Multag) in patients with previously normal hepatic serum enzymes. Both patients were female and approximately 70 years of age. In the first case, the patient had underlying intermittent atrial fibrillation, arterial hypertension and stable coronary artery disease. She was treated with dronedarone (Multag) for 4.5 months. Two weeks prior to hospitalization she reported increased exhaustion and tiredness. One week prior to admission she discontinued dronedarone, and at the time of admission she was noted to have jaundice, coagulopathy, transaminitis and hyperbilirubinemia, which progressed to hepatic encephalopathy over the next nine days. A pre-transplant workup did not reveal another etiology of liver failure. In the second case, the patient had a medical history of paroxysmal atrial fibrillation and Sjogren’s syndrome. Following 6 months of treatment with dronedarone she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia. She was transplanted 1 month later; no alternative etiology for liver failure was identified in the transplant work-up. In both cases, the explanted liver showed evidence of extensive hepatocellular necrosis.

Multaq (dronedarone) is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.

Dronedarone (Multag) is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II – III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone. 

1. SDI, Vector One®: National (VONA) and Total Patient Tracker (TPT). July 2009-October 2010. Data extracted 12-14-10.
-
Related Information

FDA Drug Safety Podcast for Healthcare Professionals: Severe liver injury associated with the use of dronedarone (marketed as Multaq)1  1/20/2011  Multaq (dronedarone) Information2  

Contact Us Report a Serious Problem

1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online3
Regular Mail: Use postage-paid FDA Form 35004
Mail to: MedWatch 5600 Fishers Lane
Rockville , MD  20857

The Fentanyl Pain Patch, also known as the Duragesic Fentanyl Pain Patch, Duragesic Transdermal Fentanyl Pain Patch, Duragesic Fentanyl Transdermal System  or Durogesic Transdermal Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) has been linked to over 120 overdose deaths and has been subject to multiple FDA recalls & Public Health Advisories.  If you or someone you know has been severely injured or killed as a result of a Duragesic brand fentanyl pain patch, or any other brand fentanyl pain patch, talk to a Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about filing a potential Fentanyl Pain Patch lawsuit.

A recall in cooperation with the U.S. Food and Drug Administration (FDA) is currently being conducted regarding Fentanyl Gel Leaks in the Duragesic brand of fentanyl pain patches. Duragesic 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system pain patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is a possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can lead to death or permanent diasability.

What is a Fentanyl Pain Patch?

Duragesic fentanyl pain patches (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) are used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. Pain patches should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. Duragesic pain patches should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl pain patches should be reported to your health-care providers. Duragesic brand and other fentanyl pain patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.

Fentanyl is 100 times more potent than morphine as an analgesic. It is a mu opioid receptor agonist with high lipid solubility and a rapid onset and short duration of effects. Fentanyl rapidly crosses the blood-brain barrier. It is similar to other mu opioid receptor agonists (like morphine or oxycodone) in its pharmacological effects and produces analgesia, sedation, respiratory depression, nausea, and vomiting. Fentanyl pain patches appear to produce muscle rigidity with greater frequency than other opioids.

Fentanyl Pain Patch Recall

In February 2004, a leading fentanyl pain patch supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl pain patches (Sold under brand names: Mylan Fentanyl Pain Patch , Sandoz Fentanyl Pain Patch, Duragesic Fentanyl Pain Patch, Watson Fentanyl Pain Patch) because of seal breaches which may allow the drug to leak from the pain patch. The recall notice warned that “exposure to the hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, and potentially life threatening complications.” Janssen also later recalled additional lots of fentanyl pain patches; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect in the fentanyl pain patches. At least one fatality, potentially due to this defect, has already been reported to the US FDA.

The 25 mcg/hr Duragesic pain patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel contained in the pain patches. Overexposure in patients, or even slight exposure in non opioid tolerant people, could result in a fatal overdose.

PriCara Recalled 25 mcg/hr Duragesic Fentanyl Transdermal Systems and CII Pain Patches from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  All lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII pain patches sold by PriCara in the United States and all 25 mcg/hr fentanyl pain patches sold by Sandoz Inc. in the United States have been voluntarily recalled as a precaution from wholesalers and pharmacies. All 25 mcg/hr fentanyl pain patches manufactured by ALZA and sold in Canada also were also recalled.

As per the approved product labeling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl pain patches that are cut or damaged in any way should not be used. Anyone who comes in contact with fentanyl gel in pain patches should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately safe-guard affected pain patches with cut edges by storing them in a plastic container in a safe place, using caution not to handle the fentanyl pain patches directly.

Defective fentanyl pain patches (Sold under brand names: Duragesic Fentanyl Pain Patches, Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch)should be kept away from children and animals and not disposed of until you have spoken to a Duragesic Pain Patch Lawsuit Lawyer - Fentanyl Pain Patch Lawsuit Attorney or healthcare professional. Pain patches with a cut edge that have leaked gel will not provide effective pain relief. Anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl pain patches should check the box or foil pouch for the expiration date to see if they have fentanyl pain patches that are being recalled. The recalled fentanyl pain patches all have expiration dates on or before December 2009. The cut edge in affected fentanyl pain patches can be seen upon opening the sealed foil pouch that holds the  fentanyl pain patch. Affected  fentanyl pain patches should not be handled directly. Patients using fentanyl painpatches who have medical questions should contact their health-care providers.

Fentanyl Pain Patch Class Action Lawsuit vs. Individual Fentanyl Pain Patch Lawsuit

There are distinct differences between a Duragesic Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) class action lawsuit and a more typical individual Duragesic Fentanyl Pain Patch lawsuit. A Fentanyl Pain Patch class action lawsuit would be a form of Pain Patch lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturer of the Duragesic Fentanyl Pain Patch (defendant).

In a class action lawsuit involving personal injury, resulting from defective Duragesic Fentanyl Pain Patches, all Duragesic Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) lawsuit plaintiffs would typically be grouped together into a single Fentanyl Pain Patch class action lawsuit, regardless of the degree or severity of their injuries. In this type of Duragesic Fentanyl Pain Patch class action lawsuit, plaintiffs with injuries ranging from minor ones not requiring further attention, all the way to the most severe injuries including potentially life threatening complications and even death by accidental overdose, would be grouped into one single Duragesic Fentanyl Pain Patch class action lawsuit. All plaintiffs in the class would share any award or settlement resulting from that Duragesic Fentanyl Pain Patch class action lawsuit.

In Duragesic Fentanyl Pain Patch lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Duragesic Fentanyl Pain Patches have been linked to severe injuries, including potentially life threatening complications and death. Duragesic Fentanyl Pain Patch (Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) cases such as these are better suited to an individual Duragesic Fentanyl Pain Patch lawsuit because of the severity and degree of injury to the plaintiff. In an individual Duragesic Fentanyl Pain Patch lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.In many cases involving Duragesic Fentanyl Pain Patches, with medical care, victims may be able to lead mostly normal and productive lives.

An individual Duragesic Fentanyl Pain Patch lawsuit allows each Duragesic Fentanyl Pain Patch victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Fentanyl Pain Patch Lawsuit Attorney

Poorly designed medications like the Duragesic brand pain patch or any other fentanyl pain patch may cause accidental overdose or other severe and devastating injuries or death. Seek immediate medical attention if you are suffering an emergency situation resulting from the use of a Duragesic brand pain patch or any other fentanyl pain patch (Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch).

If you or someone you know has been severely injured as a result of a Duragesic brand pain patch or any other other fentanyl pain patch, talk to a Duragesic Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about a potential Fentanyl Pain Patch lawsuit.  You are not alone.  Join other Duragesic fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Duragesic Fentanyl Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, the makers of the Duragesic Fentanyl Pain Patch and in filing a Fentanyl Pain Patch Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a Duragesic Fentanyl Pain Patch lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

The Fentanyl filled Duragesic Patch, also known as the Duragesic Fentanyl Patch, Duragesic Transdermal Fentanyl Patch, Duragesic Fentanyl Transdermal System or Durogesic Transdermal Fentanyl Pain Patch has been linked to over 120 overdose deaths and has been subject to multiple US FDA recalls & Public Health Advisories.  If you or someone you know has died or been severely injured as a result of using a Duragesic brand pain patch, or any other fentanyl pain patch, talk to a Duragesic Fentanyl Lawsuit Lawyer at the Willis Law Firm for legal advice about filing a potential Duragesic Lawsuit.

A recall in cooperation with the U.S. Food and Drug Administration (FDA) is currently being conducted regarding Fentanyl Gel Leaks in the Duragesic brand of pain patches. Duragesic 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is a possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can lead to death or permanent diasability.

Duragesic Pain Patch Recall

In February 2004, a leading fentanyl supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl (brand name: Duragesic) patches because of seal breaches which may allow the drug to leak from the patch. The recall notice warned that “exposure to the Duragesic hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications.” Janssen also later recalled additional lots; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA.

The 25 mcg/hr Duragesic patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel. Overexposure in patients, or even slight exposure in non opioid tolerant people, could possibly result in a fatal overdose.

PriCara Recalled 25 mcg/hr Duragesic Fentanyl Transdermal Systems and CII Pain Patches from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  All lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States have been voluntarily recalled as a precaution from wholesalers and pharmacies. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also were also recalled.

As per the approved product labeling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately safe-guard affected patches with cut edges by storing them in a plastic container in a safe place, using caution not to handle them directly.

Defective fentanyl patches should be kept away from children and animals and not disposed of until you have spoken to a Duragesic Lawsuit Lawyer - Fentanyl Lawsuit Attorney or healthcare professional. Patches with a cut edge that have leaked gel will not provide effective pain relief. Anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly. Patients using fentanyl patches who have medical questions should contact their health-care providers.

What are Duragesic Fentanyl Patches?

Duragesic patches are used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. Duragesic should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl patches should be reported to your health-care providers. Duragesic brand and other fentanyl patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.

Fentanyl is 100 times more potent than morphine as an analgesic. It is a mu opioid receptor agonist with high lipid solubility and a rapid onset and short duration of effects. Fentanyl rapidly crosses the blood-brain barrier. It is similar to other mu opioid receptor agonists (like morphine or oxycodone) in its pharmacological effects and produces analgesia, sedation, respiratory depression, nausea, and vomiting. Fentanyl appears to produce muscle rigidity with greater frequency than other opioids.

Duragesic Class Action Lawsuit vs. Individual Duragesic Fentanyl Lawsuit

There are distinct differences between a Duragesic Fentanyl Transdermal Pain Patch class action lawsuit and a more typical individual Duragesic Fentanyl Transdermal Pain Patch lawsuit. A Duragesic Fentanyl class action lawsuit would be a form of Duragesic lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturer of the Duragesic Fentanyl Transdermal Pain Patch (defendant).

In a class action lawsuit involving personal injury, resulting from defective Duragesic Fentanyl Transdermal Pain Patches, all Duragesic lawsuit plaintiffs would typically be grouped together into a single Duragesic Fentanyl Transdermal Pain Patch class action lawsuit, regardless of the degree or severity of their injuries. In this type of Duragesic Fentanyl Transdermal class action lawsuit, plaintiffs with injuries ranging from minor ones not requiring further attention, all the way to the most severe injuries including potentially life threatening complications and even death by accidental overdose, would be grouped into one single Duragesic Fentanyl Transdermal Pain Patch class action lawsuit. All plaintiffs in the class would share any award or settlement resulting from that Duragesic Fentanyl Transdermal Pain Patch class action lawsuit.

In Duragesic Fentanyl Transdermal Pain Patch lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Duragesic Fentanyl Transdermal Pain Patches have been linked to severe injuries, including potentially life threatening complications and death. Duragesic Fentanyl Transdermal Pain Patch cases such as these are better suited to an individual Duragesic Fentanyl Transdermal Pain Patch lawsuit because of the severity and degree of injury to the plaintiff. In an individual Duragesic Fentanyl Transdermal Pain Patch lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.In many cases involving Duragesic Fentanyl Transdermal Pain Patches, with medical care, victims may be able to lead mostly normal and productive lives.

An individual Duragesic Fentanyl Transdermal Pain Patch lawsuit allows each Duragesic Fentanyl Transdermal Pain Patch victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Duragesic Lawsuit Attorney

Poorly designed medications like the Duragesic brand pain patch or any other fentanyl pain patches may cause accidental overdose or other severe and devastating injuries. Seek immediate medical attention if you are suffering an emergency situation resulting from the use of a Duragesic brand pain patch or any other fentanyl pain patch.

If you or someone you know has been severely injured as a result of a Duragesic brand and other fentanyl pain patch, talk to a Duragesic fentanyl lawsuit Attorney at the Willis Law Firm for legal advice about a potential Duragesic lawsuit.  You are not alone.  Join other Duragesic fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Duragesic Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, the makers of the Duragesic Pain Patch and in filing a Duragesic Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a Duragesic fentanyl lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

The Duragesic Pain Patch, also known as the Duragesic Fentanyl Pain Patch, Duragesic Transdermal Fentanyl Pain Patch, Duragesic Fentanyl Transdermal System  or Durogesic Transdermal Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) has been linked to over 120 overdose deaths and has been subject to multiple FDA recalls & Public Health Advisories.  If you or someone you know has been severely injured or killed as a result of a Duragesic brand fentanyl pain patch, or any other brand fentanyl pain patch, talk to a Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about filing a potential Fentanyl Pain Patch lawsuit.

A recall in cooperation with the U.S. Food and Drug Administration (FDA) is currently being conducted regarding Fentanyl Gel Leaks in the Duragesic brand of fentanyl pain patches. Duragesic 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system pain patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is a possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can lead to death or permanent diasability.

What is a Duragesic Pain Patch?

Duragesic fentanyl pain patches (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) are used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. Pain patches should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. Duragesic pain patches should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl pain patches should be reported to your health-care providers. Duragesic brand and other fentanyl pain patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.

Fentanyl is 100 times more potent than morphine as an analgesic. It is a mu opioid receptor agonist with high lipid solubility and a rapid onset and short duration of effects. Fentanyl rapidly crosses the blood-brain barrier. It is similar to other mu opioid receptor agonists (like morphine or oxycodone) in its pharmacological effects and produces analgesia, sedation, respiratory depression, nausea, and vomiting. Fentanyl pain patches appear to produce muscle rigidity with greater frequency than other opioids.

Duragesic Pain Patch Recall

In February 2004, a leading fentanyl pain patch supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl pain patches (Sold under brand names: Mylan Fentanyl Pain Patch , Sandoz Fentanyl Pain Patch, Duragesic Fentanyl Pain Patch, Watson Fentanyl Pain Patch) because of seal breaches which may allow the drug to leak from the pain patch. The recall notice warned that “exposure to the hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, and potentially life threatening complications.” Janssen also later recalled additional lots of fentanyl pain patches; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect in the fentanyl pain patches. At least one fatality, potentially due to this defect, has already been reported to the US FDA.

The 25 mcg/hr Duragesic pain patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel contained in the pain patches. Overexposure in patients, or even slight exposure in non opioid tolerant people, could result in a fatal overdose.

PriCara Recalled 25 mcg/hr Duragesic Fentanyl Transdermal Systems and CII Pain Patches from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  All lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII pain patches sold by PriCara in the United States and all 25 mcg/hr fentanyl pain patches sold by Sandoz Inc. in the United States have been voluntarily recalled as a precaution from wholesalers and pharmacies. All 25 mcg/hr fentanyl pain patches manufactured by ALZA and sold in Canada also were also recalled.

As per the approved product labeling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl pain patches that are cut or damaged in any way should not be used. Anyone who comes in contact with fentanyl gel in pain patches should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately safe-guard affected pain patches with cut edges by storing them in a plastic container in a safe place, using caution not to handle the fentanyl pain patches directly.

Defective fentanyl pain patches (Sold under brand names: Duragesic Fentanyl Pain Patches, Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch)should be kept away from children and animals and not disposed of until you have spoken to a Duragesic Pain Patch Lawsuit Lawyer - Fentanyl Pain Patch Lawsuit Attorney or healthcare professional. Pain patches with a cut edge that have leaked gel will not provide effective pain relief. Anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl pain patches should check the box or foil pouch for the expiration date to see if they have fentanyl pain patches that are being recalled. The recalled fentanyl pain patches all have expiration dates on or before December 2009. The cut edge in affected fentanyl pain patches can be seen upon opening the sealed foil pouch that holds the  fentanyl pain patch. Affected  fentanyl pain patches should not be handled directly. Patients using fentanyl painpatches who have medical questions should contact their health-care providers.

Duragesic Pain Patch Class Action Lawsuit vs. Individual Duragesic Pain Patch Lawsuit

There are distinct differences between a Duragesic Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) class action lawsuit and a more typical individual Duragesic Fentanyl Pain Patch lawsuit. A Fentanyl Pain Patch class action lawsuit would be a form of Pain Patch lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturer of the Duragesic Fentanyl Pain Patch (defendant).

In a class action lawsuit involving personal injury, resulting from defective Duragesic Fentanyl Pain Patches, all Duragesic Fentanyl Pain Patch (Also sold under brand names: Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) lawsuit plaintiffs would typically be grouped together into a single Fentanyl Pain Patch class action lawsuit, regardless of the degree or severity of their injuries. In this type of Duragesic Fentanyl Pain Patch class action lawsuit, plaintiffs with injuries ranging from minor ones not requiring further attention, all the way to the most severe injuries including potentially life threatening complications and even death by accidental overdose, would be grouped into one single Duragesic Fentanyl Pain Patch class action lawsuit. All plaintiffs in the class would share any award or settlement resulting from that Duragesic Fentanyl Pain Patch class action lawsuit.

In Duragesic Fentanyl Pain Patch lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Duragesic Fentanyl Pain Patches have been linked to severe injuries, including potentially life threatening complications and death. Duragesic Fentanyl Pain Patch (Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch) cases such as these are better suited to an individual Duragesic Fentanyl Pain Patch lawsuit because of the severity and degree of injury to the plaintiff. In an individual Duragesic Fentanyl Pain Patch lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.In many cases involving Duragesic Fentanyl Pain Patches, with medical care, victims may be able to lead mostly normal and productive lives.

An individual Duragesic Fentanyl Pain Patch lawsuit allows each Duragesic Fentanyl Pain Patch victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Duragesic Pain Patch Lawsuit Attorney

Poorly designed medications like the Duragesic brand pain patch or any other fentanyl pain patch may cause accidental overdose or other severe and devastating injuries or death. Seek immediate medical attention if you are suffering an emergency situation resulting from the use of a Duragesic brand pain patch or any other fentanyl pain patch (Mylan Fentanyl Pain Patch, Sandoz Fentanyl Pain Patch, Janssen Fentanyl Pain Patch, Watson Fentanyl Pain Patch).

If you or someone you know has been severely injured as a result of a Duragesic brand pain patch or any other other fentanyl pain patch, talk to a Duragesic Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about a potential Fentanyl Pain Patch lawsuit.  You are not alone.  Join other Duragesic fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Duragesic Fentanyl Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, the makers of the Duragesic Fentanyl Pain Patch and in filing a Fentanyl Pain Patch Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a Duragesic Fentanyl Pain Patch lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

The Duragesic Patch, also known as the Duragesic Fentanyl Patch, Duragesic Transdermal Fentanyl Patch or Durogesic Transdermal Fentanyl Pain Patch has been linked to over 120 overdose deaths and has been subject to multiple FDA recalls & Public Health Advisories.  If you or someone you know has been severely injured or killed as a result of a Duragesic brand pain patch, or any other fentanyl pain patch, talk to a Duragesic Fentanyl Lawsuit Attorney at the Willis Law Firm for legal advice about filing a potential Duragesic lawsuit.

A recall in cooperation with the U.S. Food and Drug Administration (FDA) is currently being conducted regarding Fentanyl Gel Leaks in the Duragesic brand of pain patches. Duragesic 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is a possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can lead to death or permanent diasability.

What are Duragesic Fentanyl Patches?

Duragesic patches are used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. Duragesic should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl patches should be reported to your health-care providers. Duragesic brand and other fentanyl patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.

Fentanyl is 100 times more potent than morphine as an analgesic. It is a mu opioid receptor agonist with high lipid solubility and a rapid onset and short duration of effects. Fentanyl rapidly crosses the blood-brain barrier. It is similar to other mu opioid receptor agonists (like morphine or oxycodone) in its pharmacological effects and produces analgesia, sedation, respiratory depression, nausea, and vomiting. Fentanyl appears to produce muscle rigidity with greater frequency than other opioids.

Duragesic Pain Patch Recall

In February 2004, a leading fentanyl supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl (brand name: Duragesic) patches because of seal breaches which may allow the drug to leak from the patch. The recall notice warned that “exposure to the Duragesic hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications.” Janssen also later recalled additional lots; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA.

The 25 mcg/hr Duragesic patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel. Overexposure in patients, or even slight exposure in non opioid tolerant people, could possibly result in a fatal overdose.

PriCara Recalled 25 mcg/hr Duragesic Fentanyl Transdermal Systems and CII Pain Patches from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  All lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States have been voluntarily recalled as a precaution from wholesalers and pharmacies. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also were also recalled.

As per the approved product labeling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately safe-guard affected patches with cut edges by storing them in a plastic container in a safe place, using caution not to handle them directly.

Defective fentanyl patches should be kept away from children and animals and not disposed of until you have spoken to a Duragesic Lawsuit Lawyer - Fentanyl Lawsuit Attorney or healthcare professional. Patches with a cut edge that have leaked gel will not provide effective pain relief. Anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly. Patients using fentanyl patches who have medical questions should contact their health-care providers.

Duragesic Class Action Lawsuit vs. Individual Duragesic Fentanyl Lawsuit

There are distinct differences between a Duragesic Fentanyl Transdermal Pain Patch class action lawsuit and a more typical individual Duragesic Fentanyl Transdermal Pain Patch lawsuit. A Duragesic Fentanyl class action lawsuit would be a form of Duragesic lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturer of the Duragesic Fentanyl Transdermal Pain Patch (defendant).

In a class action lawsuit involving personal injury, resulting from defective Duragesic Fentanyl Transdermal Pain Patches, all Duragesic lawsuit plaintiffs would typically be grouped together into a single Duragesic Fentanyl Transdermal Pain Patch class action lawsuit, regardless of the degree or severity of their injuries. In this type of Duragesic Fentanyl Transdermal class action lawsuit, plaintiffs with injuries ranging from minor ones not requiring further attention, all the way to the most severe injuries including potentially life threatening complications and even death by accidental overdose, would be grouped into one single Duragesic Fentanyl Transdermal Pain Patch class action lawsuit. All plaintiffs in the class would share any award or settlement resulting from that Duragesic Fentanyl Transdermal Pain Patch class action lawsuit.

In Duragesic Fentanyl Transdermal Pain Patch lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. Duragesic Fentanyl Transdermal Pain Patches have been linked to severe injuries, including potentially life threatening complications and death. Duragesic Fentanyl Transdermal Pain Patch cases such as these are better suited to an individual Duragesic Fentanyl Transdermal Pain Patch lawsuit because of the severity and degree of injury to the plaintiff. In an individual Duragesic Fentanyl Transdermal Pain Patch lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.In many cases involving Duragesic Fentanyl Transdermal Pain Patches, with medical care, victims may be able to lead mostly normal and productive lives.

An individual Duragesic Fentanyl Transdermal Pain Patch lawsuit allows each Duragesic Fentanyl Transdermal Pain Patch victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Duragesic Lawsuit Attorney

Poorly designed medications like the Duragesic brand pain patch or any other fentanyl pain patches may cause accidental overdose or other severe and devastating injuries. Seek immediate medical attention if you are suffering an emergency situation resulting from the use of a Duragesic brand pain patch or any other fentanyl pain patch.

If you or someone you know has been severely injured as a result of a Duragesic brand and other fentanyl pain patch, talk to a Duragesic fentanyl lawsuit Attorney at the Willis Law Firm for legal advice about a potential Duragesic lawsuit.  You are not alone.  Join other Duragesic fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Duragesic Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, the makers of the Duragesic Pain Patch and in filing a Duragesic Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a Duragesic fentanyl lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

Department of Health and Human Services

 Sanofi Aventis Deutschland GmbH 2/9/11
   
Public Health Service
Food and Drug Administration – Silver Spring  MD 20993
 
Warning Letter
VIA UPS MAIL  
WL: 320-11-09
 
February 9, 2011
 
Mr. Martin Siewert, Chairman of the Board
Sanofi Aventis Deutschland GmbH
Industriepark Hochst, Building H550
Frankfurt am Main   65926
Germany
 
Dear Mr. Siewert:
 
During our September 6-10, 13-16, 2010 inspection of your pharmaceutical manufacturing facility, Sanofi Aventis Deutschland GmbH, Industriepark Hochst, Building H550, Frankfurt am Main, Germany, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
 
We have reviewed your firm’s responses in October 2010 and January 2011, however we continue to have concerns related to your firm’s compliance with CGMP.
 
Specific violations observed during the inspection include, but are not limited to the following:
 
1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. For example,
 
For example, in June 2010, your firm failed to identify the organisms recovered from a sterility test for Apidra lot #OF100. Identification of microorganisms recovered from a sterility test is essential when conducting a sterility failure investigation. In addition, the identification of organisms is also a fundamental part of any investigation of environmental or personnel monitoring excursions.
 
Your firm’s failure to identify organisms recovered from a sterility test was also discussed during the December 2008 inspection.
 
We recognize that your firm voluntarily recalled the Apidra, Lot#0F151A, which was  part of the February 2010 production campaign in which there was a significant concern regarding environmental contamination levels. We expect all procedures related to the response for an out-of-limit environmental monitoring sample or a sterility failure to include the appropriate evaluation and remedial measures, as appropriate.
                                                                                                                               
2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example,
 
a) The airflow velocity inside critical areas of the aseptic processing operations of Line (b)(4) was found unacceptable by FDA. The documentary evidence of in-situ air pattern analysis (e.g., smoke studies) reviewed during the inspection confirmed this condition.
                                                                
With respect to aseptic processing in critical areas, you should be able to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions. Please note that proper design and control prevents turbulence and stagnant air in the critical areas. It is crucial that airflow patterns are evaluated for turbulence that can act as a channel for contamination, and that any deficient conditions are addressed.
 
b) Your environmental monitoring program does not give assurance that environmental contaminants are reliably detected. Your practice of collecting samples from the gloves of operators, from left and right hands on alternate days is unacceptable. In addition, your SOP fails to include instructions for the location and duration of samples collected in the critical aseptic processing areas.
                                                                      
An adequate environmental monitoring program should be established by your firm. It should capture meaningful data and act as an early warning system to detect possible environmental contaminants that may impact the sterility of drug products manufactured at your facility that purport to be sterile.
 
3. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. [21 C.F.R. § 211.25(a)]. For example,
 
On September 6 and 9, 2010, operators involved in the cleaning operations and aseptic connections during filling, were observed demonstrating incorrect aseptic techniques to prevent product contamination. We expect that operators who conduct operations within aseptic processing areas be properly trained and monitored to ensure that proper aseptic techniques are utilized during all operations.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.  If you wish to continue to ship your products to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.
 
Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, FDA may be refusing admission of articles manufactured at Sanofi Aventis Deutschland GmbH, Industriepark Hochst, Building H550, Frankfurt am Main, Germany, into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].
                                                                                                              
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please identify your response with FEI # 3002807197.
 
If you have questions or concerns regarding this letter, contact Douglas Campbell, Compliance Officer, at the below address and telephone number.
 
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Division of Manufacturing and Product Quality
International Compliance Branch
White Oak, Building 51, Room 4224
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-3201
Fax: (301) 847-8741                                                       
 
Sincerely,
/S/
Richard L. Friedman
Director
Division of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

Speak to a Multaq Lawyer about a Multaq Liver Failure Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, acute liver failure or acute hepatic failure please contact a Multaq Liver Failure Lawsuit Attorney at our law firm immediately. It may be too late to recover from the devastating effects of Multaq, but an experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of this dangerous drug. You are not alone. Join other liver failure victims and their families in speaking up and fighting for your legal rights.

Please fill out our free online legal evaluation form and we will contact you within 24 hours, or call our offices at 1-800-883-9858 for immediate help. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

In the article below, published by the US FDA in February 2011, prescription drugs are cited by the FDA as one of the major causes of acute liver failure and liver damage.  In a February 14, 2011 FDA Warning Letter, the FDA warns patients and healthcare professionals of multiple instances of Multaq related cases of acute liver failure, which required liver transplants.

“[1-14-2011] The U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients about cases of rare, but severe liver damage, including two cases of acute liver failure leading to liver transplants in patients treated with the heart medication dronedarone (Multaq).”

“[1-25-2011] The U.S. Food and Drug Administration – Research Areas

Drug-Induced Liver Toxicity

Drugs sometimes cause serious injuries to the livers of patients, with loss of hepatic function leading to illness, disability, hospitalization, and even life threatening liver failure and death or need for liver transplantation. As our aging world population uses more and more drugs, as well as self-prescribed over-the-counter medications, so-called “dietary supplements,” special diets, alcohol, and is exposed also to environmental chemicals, chances of such injury are rising. In the United States, drug-induced liver injury (DILI) is now the leading cause of acute liver failure (ALF), exceeding all other causes combined [see below: recent graphic data from WM Lee and colleagues from the Acute Liver Failure Study Group, updated to include data through December 2010]:  

This (FDA) website is intended to present up-to-date presentations and discussions on issues pertinent to DILI, as well as some background information from previous conferences. The site is sponsored by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), together with the American Association for the Study of Liver Diseases¹ (AASLD), the Drug-Induced Liver Injury Network² (DILIN) of the National Institute of Diabetes and Digestive and Kidney Diseases³ (NIDDK), and Pharmaceutical Research and Manufacturers of America (PhRMA).  The 2011 meeting will be held on Wednesday and Thursday, March 23-24, at the National Labor College in Silver Spring, Maryland.

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Lexapro (Generic: escitalopram). Research suggests serious Lexapro side effects, including the increased risk of congenital heart defects and other congenital birth defects. This link between SSRI antidepressants like Lexapro (escitalopram) and congenital heart defects has many professional concerned that women should not be prescribed the medication Lexapro (escitalopram) or other SSRIs during pregnancy. In addition to serious congenital Heart Birth Defects, SSRIs like Lexapro, Celexa, Prozac, Zoloft and Paxil have also been linked to increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).

Antidepressant Drugs Include:

What is Lexapro?

Lexapro (Generic: escitalopram) is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class. It has FDA approval to treat major depression, and is prescribed off-label for a number of anxiety conditions. Citalopram, (Brand name: Celexa), originally created in 1989 by the pharmaceutical company Lundbeck was the forerunner of Lexapro. The patent for Celexa expired in 2003, allowing other companies to legally produce generic versions. Lundbeck then released an updated formulation called escitalopram (Brand name: Lexapro), which is the S-enantiomer of the racemic citalopram, and acquired a new patent for it. In the United States, Forest Labs currently manufactures and markets the drug.

Lexapro (escitalopram) is approved to treat the symptoms of major depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. Lexapro (escitalopram) and other SSRIs like Prozac, Paxil and Zoloft can also be used to treat hot flashes. Escitalopram is sold under the brand-name Lexapro (U.S. and Canada, Forest Laboratories, Inc.). Lexapro (escitalopram) is available in 5 mg, 10 mg and 20 mg tablets, as well as an oral solution.

Lexapro Birth Defects

Lexapro (escitalopram) and other SSRI antidepressants has been linked to increased risk of serious birth defects including Primary Pulmonary Hypertension of the Newborn (PPHN) and congenital heart defects. A study published in the New England Journal of Medicine revealed that newborns whose mothers took SSRI antidepressants such as Lexapro during pregnancy were six times more likely to be born with the cario-pulmonary birth defect PPHN than those whose mothers did not take prescribed antidepressants – PPHN rose as high as 12 cases per 1,000 births.

Another study published in Pediatrics (February, 2004) found that pregnant women who used SSRIs had an increased risk of giving birth to babies with abnormal heart rhythms, unusual sleeping patterns, disrupted neurological development and problems with alertness.

A study summarized on Web MD reported that newborns exposed to SSRI antidepressants such as Lexapro by their pregnant mothers late in pregnancy were twice as likely to risk admission to special-care nurseries and twice as likely to suffer respiratory complications serious enough to require hospital ventilation procedures.

In addition to PPHN, SSRI antidepressants like Lexapro, Celexa, Paxil, Prozac and Zoloft have been linked to severe congenital heart defects, including: atrial septal defects (ASD – hole in the heart), ventricular septal defects (VSD – hole in the heart), tetrology of fallot (ToF), hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA or TOGA), patent ductus arteriosus (PDA), total anomalous pulmonary venous return (TAPVR), coarctation of the aorta (CoA), double outlet right ventricle (DORV), and Shone’s Complex. These injuries range from minor heart murmurs not requiring surgery, all the way to the most severe congenital heart defects, requiring multiple surgeries or potentially a complete heart transplant in order to save the life of the child.

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Lexapro (Generic: escitalopram). Research suggests serious Lexapro side effects, including the increased risk of congenital heart defects and other congenital birth defects. This link between SSRI antidepressants like Lexapro (escitalopram) and congenital heart defects has many professional concerned that women should not be prescribed the medication Lexapro (escitalopram) or other SSRIs during pregnancy. In addition to serious congenital Heart Birth Defects, SSRIs like Lexapro, Celexa, Prozac, Zoloft and Paxil have also been linked to increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN).

Lexapro Side Effects

In the United States, Lexapro (escitalopram), like other SSRI antidepressants, carries a black box warning stating that it may increase suicidal thinking and behavior in those under age 24.

Lexapro (escitalopram) theoretically causes side effects by increasing the concentration of serotonin in other parts of the body (e.g., the intestines). Other side effects, such as increased apathy and emotional flattening, may be caused by the decrease in dopamine release that is associated with increased serotonin. Lexapro (escitalopram) is also a mild antihistamine, which may be responsible for some of its sedating properties.

Common side effects of escitalopram include drowsiness, insomnia, nausea, weight changes, frequent urination, decreased sex drive, anorgasmia, dry mouth, increased sweating, trembling, diarrhea, excessive yawning, and fatigue. Less common side effects include bruxism, vomiting, cardiac arrhythmia, blood pressure changes, dilated pupils, anxiety, mood swings, headache, and dizziness. Rare side effects include convulsions, hallucinations, and severe allergic reactions. If sedation occurs, the dose may be taken at bedtime rather than in the morning.

Congenital Heart Defects from Antidepressant SSRI Drugs:

• Hypoplastic Left Heart Syndrome (HLHS)
• Pulmonary Atresia
• Tricuspic Atresia
• Transposition of the Great Vessels
• Transposition of the Great Arteries
• Atrial Septal Defect (hole in the heart)
• Ventricular Septal Defect (hole in the heart)
• Coarctation of the Aorta
• Tetralogy of Fallot
• Double Outlet Right Ventricle
• Truncus Arteriosus
• Double Inlet Left Ventricle
• Double Aortic Arch
• Pulmonary Valve Stenosis
• Patent Ductus Arteriosus
• Tetralogy of Fallot

SSRI Antidepressant Congenital Birth Defects:

• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Omphalcele – Abdominal Wall Malformation
• Gastrochesis – Abdominal Wall Malformation
• Craniosynostosis – Cranio-facial Malformation
• Clubfoot – Limb Malformation
• Hypospadias

Lexapro Class Action Lawsuit vs. Individual Lexapro Lawsuit

There are distinct differences between a Lexapro (escitalopram) class action lawsuit and a more typical individual Lexapro lawsuit. A Lexapro class action lawsuit would be a form of Lexapro lawsuit in which a large group of people (plaintiffs) collectively bring a lawsuit to court in the form of a “class action” against the manufacturers of Lexapro (defendant). In a class action lawsuit involving personal injury, resulting from defective products such as antidepressant SSRI drugs like Lexapro (escitalopram), Paxil (paroxetine), Zoloft (sertraline), Prozac (fluoxetine) and Celexa (citalopram), all Lexapro lawsuit plaintiffs would typically be grouped together into a single Lexapro class action lawsuit, regardless of the degree or severity of their birth defect injuries. In this type of Lexapro class action lawsuit, plaintiffs with injuries ranging from minor heart murmurs not requiring surgery, all the way to the most severe congenital heart defects, requiring multiple surgeries or a complete heart transplant, would be grouped into one single Lexapro class action lawsuit. All plaintiffs in the class would equally share any award or settlement resulting from the Lexapro class action lawsuit.

In Lexapro lawsuits involving catastrophic injury or death, an individual lawsuit, in most cases, is more appropriate and in the plaintiff’s best interest. SSRI antidepressants like Lexapro, Celexa, Paxil, Prozac and Zoloft have been linked to severe congenital heart defects, including: atrial septal defects (ASD – hole in the heart), ventricular septal defects (VSD – hole in the heart), tetrology of fallot (ToF), hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA or TOGA), patent ductus arteriosus (PDA), total anomalous pulmonary venous return (TAPVR), double outlet right ventricle (DORV), and coarctation of the aorta (CoA). Lexapro cases such as these are better suited to an individual Lexapro lawsuit because of the severity and degree of injury to the plaintiff. In an individual Lexapro Lawsuit, each plaintiff’s case is filed, presented and considered individually, based on its own strength and degree of injury.

In many cases involving SSRI antidepressants like Lexapro, Celexa, Paxil, Prozac and Zoloft and the serious congenital heart defects related to these SSRI antidepressants, surgery is required. Heart surgery will typically be required when a child is an infant or toddler and then again, potentially multiple times, as the child grows to maturity. In many cases, with surgery and medical care, children may be able to lead mostly normal and productive lives. An individual Lexapro lawsuit allows each Lexapro victim, their injuries and their future needs to be considered on an individual basis when determining damages, awards and settlement amounts, and not as part of a class action lawsuit.

Lexapro Autism

A recent study published by Archives of General Psychiatry has found a link between antidepressant use during pregnancy and Autism Spectrum Disorder (ASD). Pregnant women taking Lexapro antidepressants during the first trimester of pregnancy may triple the chances of their child having Lexapro autism. This study was prompted when researchers noticed a rise over the past few years in the use of selective serotonin reuptake inhibitor antidepressant (SSRIs) and an increase in Lexapro autism diagnoses.

Lexapro Autism Side Effects

• Autism from Lexapro
• ASD – Autism Spectrum Disorder
• PDD – Pervasive Developmental Disorder
• PDD – NOS – Pervasive Developmental Disorder – Not Otherwise Specified

If you or a loved one took Lexapro while pregnant and have a child that may suffer Lexapro autism or other Lexapro birth defects, contact our law firm immediately to discuss the legal options available to you and your family.

See also: Autism Lawsuit: Antidepressants During Pregnancy Increase Autism Risk

Speak to a Lexapro Lawyer

If you took Lexapro during pregnancy and your child was born with a severe birth defect, we encourage you to contact a Lexapro litigation attorney at our law firm immediately. It may be too late to recover from the debilitating effects of Lexapro, but an experienced products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of Lexapro. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.

Lexapro Birth Defect Lawsuit

Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.