Articles tagged: Liver Damage

Crestor-40mg-pillsAstraZeneca, the global top-ten pharmaceutical giant and manufacturer – marketer of the popular cholesterol drug Crestor (Rosuvastatin), is being confronted with the possibility of very serious and potentially life threatening sides effects associated its billion-dollar cholesterol drug.  Crestor (Rosuvastatin) is currently a very popular cholesterol lowering “statin” drug (category of all cholesterol lowering drugs).  Through independent research studies, Crestor, because of its unique formulation is being shown to have significantly higher potential risks for certain serious side effects.  According to documentation, the US Food and Drug Administration (FDA) appears to have not been aware of these risks when it approved Crestor for sale in the US in 2003.

One of the major side effects of Crestor (Rosuvastatin) is a potentially life threatening disorder known as Rhabdomyolysis.  Rhabdomyolysis is a muscle disease that depletes muscle-mass and strength in the human body.  Sometimes this muscle depletion occurs only in specific and limited areas of the body, while in some instances, the muscle-mass loss occurs over the entire body.  Regardless of which manifestation of Rhabdomyolysis occurs, the heart is clearly at risk.  In simple terms, Rhabdomyolysis can cause weakness and damage in the most important muscle in the body, the heart.

In a research study conducted by the independent watchdog group, Public Citizen, prescription data for Crestor was compared to that of other statin drugs. This research study showed that Crestor caused rhabdomyolysis almost 22 times more than its lowest dose competitor and 3 times more than its highest dose competitor. These are highly significant results.

Crestor-bottle-pillsThe reason for the study’s outcome is that the higher the dose of the active ingredient, Rosuvastatin, the higher the risk of rhabdomyolysis. AstraZeneca, the Swiss drug giant, promotes Crestor as being the most powerful statin on the market.  This may be true, but at what cost to a patient’s health? Especially since Crestor’s advertised “strength” comes from a significantly higher dosage of Rosuvastatin, its active ingredient. Recent studies have shown that only 10 mg of Crestor (Rosuvastatin) has a significantly positive effect, but these positive benefits plateau and the negative side effects of rhabdomyolysis, heart failure, heart attack, stroke liver failure, kidney failure, and potentially diabetes increase significantly at the higher prescribed and advertised dosages.

At the higher prescribed dosages, Crestor may indeed have slightly better results, but the risks for heart damage, stroke, kidney damage, liver damage and even diabetes begin to far outweigh any possible extra benefits gained.

Crestor: Heart Attacks, Heart Failure and Strokes?

Heart-attackAs with all statins a cholesterol patient will notice weakness and fatigue. If this turns into rhabdomyolysis, then the benefits of lower risk of heart attack through lower cholesterol and potentially unclogged arteries is soon undone. The potential problems of higher cholesterol are then replaced with a very real and long lasting disease that may be worse than the original cholesterol problem.  Rhabdomyolysis has the potential to cause a series of serious problems including heart attack, stroke, kidney failure, liver failure, and possibly even diabetes.

John Kjekshus of the University of Oslo and his colleagues conducted a study of 5000 cholesterol sufferers which showed that the benefits of Crestor were not as significant as advertised, when compared to a placebo (non-working dummy medication) in the study, but the weakening of the heart from rhabdomyolysis became a very major concern, especially in patients who were already at risk for possible heart failure.

“Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair,” John Kjekshus of the University of Oslo said.

There is a difference between a heart attack and heart failure. Heart failure is a hard-to-treat condition in which the weakened heart cannot pump enough blood to meet the body’s need for oxygen, causing shortness of breath or other complications. Heart failure is a leading cause of hospitalization among the elderly.

But at a certain point the depletion of the heart muscle from rhabdomyolysis leads not only to heart attacks, but also to strokes. Strokes are due to the lack of blood pressure flowing through the brain from the heart potentially weakened by rhabdomyolysis. Strokes can lead to paralysis, loss of speech, severely degraded cognitive ability or death.

Crestor-20mg-pillsThe Swiss drug giant AstraZeneca produced and heavily marketed Crestor to profit from the increased awareness of high-cholesterol and its potential serious affects on the health of some as they age. Crestor, having a significantly higher dose of rosuvastatin as compared to other statins, makes it unique.  This significantly higher dosage may actually be the wrong approach to the root cause of the problem of high cholesterol. In actuality, this formulation may make the side effects much, much worse, with few if any additional benefits to warrant the increased risk.

The increased dosage of Crestor has been found in a study conducted by Public Citizen to cause Crestor patients to also have renal (kidney) failure 75 times more than other statins. That is a much higher risk of kidney failure with Crestor than with other statins. This is an especially major risk and complication for cholesterol patients who may have already had kidney problems or may be suffering from liver damage at the time they are prescribed Crestor.

These study results prompted a request to the FDA in 2004 that they take Crestor off of the market. The FDA responded to that request with the results of AstraZeneca-sponsored research projects, and a firm refusal. The FDA has currently yet to revise or strengthen the side effects and warnings on the drug package label or order any other independent studies of their own to address these claims or to resolve the issue through research and objective science.

AstraZeneca’s sales of Crestor have been rising steadily with sales of more than $2.5 billion per year in 56 markets around the world. In other words, millions upon millions of cholesterol patients worldwide, some already with diminished heart, kidney and liver functionality, are being put at risk of the serious and possibly life threatening Crestor side effects.  According the referenced studies, Crestor’s side effects include heart failure, heart attack, stroke, kidney failure, liver failure, and diabetes, among other health risks.

Please Note: We are not currently accepting Crestor Cases.

Multaq (dronedarone), the popular antiarrhythmia drug manufactured and marketed by Sanofi – Aventis SA, has been linked by the U.S. FDA to acute liver damage, severe liver toxicity, acute hepatic failure, acute liver failure and other complications and damage of the liver and hepatic system, often requiring surgery and some cases a liver transplant.

Multaq Pill Bottle LabelIn the January 14, 2011 FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq).  [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). Following this FDA Warning, it has been speculated that the FDA would eventually need to add a new Black Box Warning about the risk of liver damage associated with the use of Multaq to the package labels of Multaq.

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver damage, liver toxicity, acute hepatic failure or acute liver failure, contact a Multaq Liver Damage 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.

Multaq Liver Transplant

What is a liver transplant?

Your liver helps fight infections and cleanses your blood. It also helps digest food and stores a form of sugar your body uses for energy. The liver is the largest internal organ in your body. You cannot live without a liver that works. If your liver stops working as it should, you may need a liver transplant.

Liver transplantation is surgery to remove a diseased or injured liver and replace it with a healthy one from another person, called a donor. Many people have had liver transplants and now lead normal lives.

What are the signs and symptoms of liver problems?

Some signs and symptoms of liver problems are

  • jaundice  (yellowing of the skin and the whites of the eyes)
  • feeling weak or tired
  • loss of appetite
  • feeling sick to the stomach
  • weight loss
  • losing muscle
  • easily bruise or bleed
  • stomach bleeding
  • blood in vomit
  • black stools
  • abdomen swollen
  • forgetfulness or confusion

What are the reasons for needing a liver transplant?

In adults, the most common reason for needing a liver transplant is liver damage and acute liver failure, which can be caused by many different types of disorders and diseases which destroy healthy liver cells and compromise the healthy function of the liver.

Causes of liver damage and liver failure are:

  • long-term infection with the hepatitis C  or B virus
  • sudden liver failure, called acute liver failure or acute hepatic , caused by the use of dangerous drugs or even too much acetaminophen (Tylenol)
  • alcohol abuse over time
  • autoimmune liver diseases
  • fatty buildup in the liver
  • hereditary liver disease

Your immune system, fights that make you sick, like bacteria and viruses. Autoimmune liver diseases happen when the immune system does not recognize your liver as a part of the body and attacks it. Hereditary diseases are genetically passed from parents to children. Liver transplants can help children and adults.

How will I know whether I need a liver transplant?

Your doctor will decide whether you need to go to a liver transplant center to be evaluated by a liver transplant team. The transplant team will examine you and run blood tests, X rays, and other tests to help decide whether you need and would benefit from a liver transplant. The team will include liver transplant surgeons; hepatologists; nurses; social workers; and other health care professionals.

The transplant team will also check if:

  • your heart, lungs, kidneys, and immune system are strong enough for surgery
  • you are mentally and emotionally ready to have a transplant
  • you have family members or friends who can care for you before and after the transplant

If you are approved for a liver transplant, you still may not choose to proceed with it.

To help with your decision, the liver transplant team will explain:

  • liver transplant patient selection process
  • liver transplant operation and recovery
  • long-term demands of living with a liver transplant, such as taking medicines for the rest of your life

During the liver transplant evaluation and while waiting for a liver transplant, you should protect your health. Your doctor will advise you of what can be done to stay strong as you wait for a new liver.

Can anyone with liver problems get a liver transplant?

Each liver transplant center has rules about who can have a liver transplant.

You may not be able to have a liver transplant if you have:

  • cancer outside the liver
  • serious heart or lung disease
  • an alcohol or drug abuse problem
  • a severe infection
  • AIDS
  • trouble following your doctor’s instructions
  • no support system

How long does it take to get a new liver?

If you need a liver transplant, your name will be placed on a national waiting list kept by the United Network for Organ Sharing (UNOS). Your blood type, body size, and how urgently you need a new liver all play a role in when you will receive a liver. Those with the most urgent need for a liver transplant to prevent death are at the top of the list. Many people have to wait a long time to get a new liver.

Your doctor will tell you what you can do to stay strong while you wait for a new liver. For information about the national waiting list, please contact the UNOS.

Where do the livers for liver transplants come from?

Most livers come from people who have just died. This type of donor is called a deceased donor. Sometimes a healthy living person will donate part of his or her liver to a patient, usually a family member. This type of donor is called a living donor. Both types of transplants usually have good results.

All donated livers and living donors are tested before transplant surgery. The testing makes sure the donor liver works as it should, matches your blood type, and is the right size, so it has the best chance of working in your body. Adults usually receive the entire liver from a deceased donor. Sometimes only a portion of a whole liver from a deceased donor is used to fit a smaller person. In some cases, a liver from a deceased donor is split into two parts. The smaller part may go to a child, and the larger part may go to an adult.

What happens in the hospital?

When a liver is available, you will need to get to the hospital quickly to be prepared for the surgery. If your new liver is from a living donor, both you and the donor will have surgery at the same time. If your new liver is from a deceased donor, your surgery will start when the new liver arrives at the hospital. The surgery can take up to 12 hours. The surgeon will remove your liver and then replace it with the donated liver.

What happens after liver transplant surgery?

You will stay in the hospital about 1 to 2 weeks to be sure your new liver is working. You’ll take medicines to prevent infections and rejection of your new liver. Your doctor will check for bleeding, infections, and liver rejection. During this time, you will learn how to take care of yourself after you go home and about the medicines you’ll need to take to protect your new liver. After surgery, you will learn how to take care of yourself when you go home.

What is organ rejection?

Rejection occurs when your immune system attacks the new liver. After a transplant, it is common for your immune system to try to destroy the new liver.

How is organ rejection prevented?

To keep your body from rejecting the new liver, you will take anti-rejection drugs, also called immunosuppressive medicines. You will need to take anti-rejection drugs for the rest of your life.

Do anti-rejection drugs following a liver transplant have any side effects?

Anti-rejection drugs can have many serious side effects. Your doctor and the transplant team will watch for and treat any side effects. You can get infections more easily because these medicines weaken your immune system.

Other possible side effects include:

  • weight gain
  • high blood pressure
  • high blood cholesterol
  • diabetes
  • brittle bones
  • kidney damage
  • skin cancer

What are the signs of organ rejection after a liver transplant?

If your body rejects your new liver, you might feel tired, lose your appetite, or feel sick to your stomach.

Other signs might include having:

  • a fever
  • pain around the liver
  • jaundice
  • dark-colored urine
  • light-colored stools

But rejection doesn’t always make you feel ill. Doctors will check your blood for signs of rejection. A liver biopsy is usually needed to tell whether your body is rejecting the new liver. For a biopsy, the doctor takes a small piece of the liver to view with a microscope. Blood tests can help show if the new liver is being rejected.

What other problems can damage my new liver?

Recurrence of the disease that caused the need for a transplant can damage a new liver. For example, the hepatitis C virus may return and damage the new liver in a patient who had hepatitis C before the transplant.

Other possible problems include:

  • blockage of the blood vessels going into or out of the liver
  • damage to the bile ducts

What if the liver transplant doesn’t work?

Liver transplants usually work. About 80 to 85 percent of transplanted livers are still working after 1 year. If the new liver does not work or if your body rejects it, your doctor and the transplant team will decide whether another transplant is possible.

How do I take care of my liver after I leave the hospital?

After you leave the hospital, you will see your doctor often to be sure your new liver is working well. You will have regular blood tests to check that your new liver is not being damaged by rejection, infections, or problems with blood vessels or bile ducts.

To help care for your liver, you will need to:

  • avoid people who are ill and report any illnesses you may have to your doctor
  • eat a healthy diet, exercise, do not smoke and not drink alcohol
  • take prescribed medicines as directed
  • ask your doctor before taking any other medicines, including over-the-counter drugs
  • have blood tests and other tests as directed by your doctor
  • Eat a healthy diet and take medicines as part of taking care of your new liver

When can I go back to my daily activities after my liver transplant?

After a successful liver transplant, most people can go back to their normal daily activities, and many return to work. Getting your strength back may take months, though, especially if you were very sick before the transplant. Your doctor will let you know how long your recovery period will be. Social workers and support groups can help you adjust to life with a new liver. If you have any questions, check with your doctor.

Speak to a Multaq Attorney about a Multaq Liver Transplant Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver damage, liver toxicity, acute hepatic failure or acute liver failure requiring liver surgery or a liver transplant, please contact a Multaq Liver Transplant 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 attorney at the Willis Law Firm can assist you in legal action against Sanofi-Aventis SA, the maker of this drug. You are not alone. Join other Multaq liver damage – liver transplant 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.

Multaq Liver Damage

Multaq (dronedarone), the popular antiarrhythmia drug manufactured and marketed by Sanofi – Aventis SA, has been linked by the US FDA to acute liver damage, severe liver toxicity, acute hepatic failure, acute liver failure and other complications and damage of the liver and hepatic system, often requiring surgery and in acute cases, a liver transplant.

Multaq Pill BottleMultaq is 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. Multaq (dronedarone) is said to reduce the risk of patient hospitalization for these heart arrhythmia problems. Since the FDA’s approval of Multaq in July 2009 until October 2010, almost a half a million Multaq prescriptions have been dispensed.  During that same time, approximately 147,000 patients filled Multaq prescriptions at retail pharmacies in the United States on an outpatient basis. In addition to outpatient Multaq prescriptions filled at retail pharmacies, a significant number of Multaq prescriptions have been filled and dispensed in hospital settings on an inpatient basis.

In the FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq).  [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). Following this FDA Warning, it has been speculated that the FDA would eventually need to add a new Black Box Warning about the risk of liver damage associated with the use of Multaq to the package labels of Multaq.

The agency recommended patients should contact their doctor if they experience signs of liver damage (listed below), including nausea, vomiting, and fever. If doctors suspect liver damage toxicity issues, the patient should discontinue Multaq use and undergo a liver enzyme test to check for potential liver damage.

Multaq PillsOn Jan, 27, 2011: 857 people reported to have side effects when taking Multaq. Among them, 21 people (2.45%) have Abnormal Liver Function Test Results. In this study of Multaq users, 21 people tested abnormal for liver function while taking Multaq. The length of Multaq use as well as gender and age of the users, and severity of the abnormal liver function test were included. The study was created by eHealthMe was based on reports from FDA and community.

Multaq Liver Damage

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver damage, liver toxicity, acute hepatic failure or acute liver failure, please contact a Multaq Liver Damage 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.

What does my liver do?

Your liver helps fight infections and cleanses your blood. It also helps digest food and stores a form of sugar your body uses for energy. The liver is the largest internal organ in your body.

What are the signs and symptoms of liver damage?

Signs and symptoms of liver damage are:

  • yellowing of the skin and the whites of the eyes, a condition called jaundice
  • feeling tired or weak
  • losing your appetite
  • nausea
  • weight loss
  • muscle loss
  • itching
  • bruising or bleeding easily
  • bleeding in the stomach
  • vomiting blood
  • passing black stools
  • swollen abdomen
  • forgetfulness or confusion

What are the reasons for needing liver surgery or a liver transplant?

You cannot live without a liver that works. If you have liver damage and your liver stops working as it should, you may need surgery to correct the liver damage or even a liver transplant to replace the damaged organ. In adults, the most common reason for needing a liver transplant is liver damage and acute liver failure, which can be caused by many different disorders and diseases, which can destroy healthy liver cells and compromise the function of a healthy liver.

Causes of liver damage and liver failure are:

  • long-term infection with the hepatitis C virus
  • sudden liver failure, called acute liver failure or acute hepatic failure, often caused by the use of dangerous drugs or even too much acetaminophen (Tylenol)
  • alcohol abuse over time
  • autoimmune liver diseases
  • long-term infection with the hepatitis B virus
  • the buildup of fat in the liver
  • hereditary liver diseases

Your body’s natural immune system keeps you healthy by fighting against things that can make you sick, such as bacteria and viruses. Autoimmune liver diseases occur when your immune system doesn’t recognize the liver as a part of your body and attacks it causing liver damage. Hereditary liver diseases are passed from parents to children through genes. For the most severe or acute forms of liver damage such as acute hepatic failure, acute liver failure, severe liver toxicity, etc., liver transplants may be the only option available that can help both children and adults.

How will I know whether I need a liver transplant?

Your doctors will decide whether your liver damage is severe enough to consult a liver transplant center, where you can be evaluated by a liver transplant team. The team will include hepatic system liver transplant surgeons; liver specialists, called hepatologists; nurses; social workers; and other health care professionals.

The transplant team will assess your liver damage to see if it is acute hepatic failure (acute liver failure) or liver damage severe enough to warrant a liver transplant.  To diagnose the severity of liver damage, they will run blood tests, X rays and other tests to help decide whether you need and would benefit from a liver transplant.

The transplant team will also check to see if:

  • your heart, lungs, kidneys, and immune system are strong enough for liver transplant surgery
  • you are mentally and emotionally ready to have a liver transplant
  • you have family members or friends who can care for you before and after the transplant

Even if you are approved for a liver transplant, you may choose not to have it. The liver transplant team will explain:

  • liver transplant patient selection process
  • liver transplant operation and recovery
  • long-term demands of living with a liver transplant, such as taking medicines for the rest of your life

After liver surgery or a liver transplant, when can I go back to my daily activities?

After successful liver surgery resulting from acute liver damage or liver failure, most people can go back to their normal daily activities, and many return to work. Getting your strength back may take months though, especially if you were very sick from your liver damage or liver failure before the liver surgery. Your doctor will let you know how long your recovery period will be.

Work - After liver failure surgery, most people are able to return to work. Your doctor will let you know when you can go back to work.

DietMost people can go back to eating as they did before the liver surgery. Some medicines prescribed after your liver surgery may cause you to gain weight, and others may cause diabetes or raise your cholesterol. Eating a balanced, low-fat diet can help you stay healthy.

ExerciseMost people can be physically active after liver surgery.

Speak to a Multaq Lawyer about a Multaq Liver Damage Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver damage, liver toxicity, acute hepatic failure or acute liver failure, please contact a Multaq Liver Damage 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 damage 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.

Multaq Liver Failure Lawsuits

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

Multaq Pill BottlePharmaceutical 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.

Multaq PillsSanofi 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.

Multaq Pill Bottle LabelIf 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.

Multaq Pill BottleWhen 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.

Multaq Blisterpack“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.
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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

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 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.

Test PDF File

FDA Warning: Sanofi Aventis

 

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]:  

 FDA Acute Liver Toxicity from Drugs

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.


Speak to a Multaq Lawyer about a Multaq Liver Damage Lawsuit

If you or a loved one took the heart medication Multaq (dronedarone) and experienced liver toxicity, acute liver damage, acute hepatic failure or acute liver failure, please contact a Multaq Liver Damage 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 damage 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.

Drug Safety Oversight Board Meeting, January 20, 2011

Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on Drug Safety Communications posted and in development since the November 18, 2010 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the November 18, 2010 DSB meeting:

  • November 19, 2010: FDA recommends against the continued use of propoxyphene:1 FDA issued a DSC notifying the public and healthcare professionals that it is recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has requested that companies voluntarily withdraw propoxyphene from the US market.
  • December 14, 2010: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age:2 FDA issued a DSC warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. The DSC also announced that new information about accidental ingestion resulting in overdose and death in children below 10 years of age is being added to the Warnings and Precautions sections of labeling for benzonatate products to make healthcare professionals aware of this safety issue.
  • December 17, 2010: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate):3 FDA issued a DSC informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that Anzemet injection can increase the risk of developing an abnormal heart rhythm (torsade de pointes), which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. The DSC also announced that a contraindication against this use (CINV) is being added to the product label for Anzemet injection.Anzemet tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label.
  • December 22, 2010: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death:4 FDA issued a DSC informing the public that results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated with recombinant human growth hormone during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. At this time, FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider.
  • January 12, 2011: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer:5 FDA issued a DSC updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. In July 2009, FDA issued an Early Communication to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus. FDA has reviewed the four studies and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis.FDA also reviewed results from a five-year randomized clinical trial, which compared Lantus to Neutral Protamine Hagedorn (NPH) insulin in individuals with Type 2 diabetes. The results did not show an increased risk of cancer in subjects treated with Lantus compared to those treated with NPH insulin; however, this study was not specifically designed to evaluate cancer outcomes. At this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information.
  • January 13, 2011: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure:6 FDA issued a DSC notifying the public and healthcare professionals that it is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
  • January 14, 2011: Severe liver injury associated with the use of dronedarone (marketed as Multaq):7 FDA issued a DSC 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).Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

The DSB discussed two topics:
1.  An Update on Operating Room Fires and Alcohol Based Skin Preps
2.  Safe Injection Practice and Vial Fill Issues

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency.

Update on Operating Room Fires and Alcohol Based Skin Preps

The Board invited guest experts from the American Society of Anesthesiologists (ASA), Chip Amoe III, J.D., M.P.A. and Charles Cowles, Jr. M.D. Mr. Amoe is the Assistant Director of Federal Affairs for ASA, representing the organization’s regulatory policy and functioning as the primary liaison between ASA and the White House, HHS, CMS, FDA, DEA, and other administrative agencies. Dr. Cowles is an assistant professor of anesthesiology at the University of Texas, MD Anderson Cancer Center in Houston, TX. Dr. Cowles is a former firefighter and is currently a representative on the ASA Task Force of the management and prevention of operating room fires.

The Board discussed the following regarding operating room fires:

  • Material presented on operating room (OR) fires at the April 2009 DSB meeting
  • The role of the Safe Use Initiative in reducing OR fires
  • The role of two FDA Centers, the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) in assessing and addressing the potential risk of OR fires
  • Scope of the current safety issue: the fire triad of fuel, oxidizer, and ignition source
  • The role of supplemental oxygen in the risk of OR fires
  • A video discussing the potential risk of an OR fire: http://www.apsf.org/resources_video.php8
  • Previous actions to minimize the risk of OR fires
  • MedWatch reports received by FDA regarding OR fires
  • Possible regulatory and non-regulatory actions to help address the safety issue

Safe Injection Practices and Vial Fill Issues

The Board invited a guest expert, Joseph Perz, DrPH, from the Centers for Disease Control and Prevention (CDC). Dr. Perz is a team leader for Ambulatory and Long Term Care in the Prevention and Response Branch of the Division of Healthcare Quality Promotion.

The Board discussed the following regarding Safe Injection Practices:

  • The scope of the safety issue
  • Examples of public health incidents that resulted from unsafe injection practices
  • The injection practices that can result in transmission of infectious disease between patients and between providers and patients
  • Provider misconceptions that lead to unsafe injection practices
  • CDC initiatives for addressing the safety issue
  • The role FDA’s Safe Use Initiative is planning in addressing this safety issue
  • Possible regulatory and non-regulatory approaches to address the safety issue

Draft Drug Safety Communication

The Board discussed a draft DSC involving over the counter monograph products and related (unapproved) prescription products used as topical anesthetics. The products have been rarely associated with methemoglobinemia and death. The Board evaluated whether the draft DSC effectively communicated, without alarm, the important messages to consumers and healthcare professionals about proper use of the products, keeping it away from children, and disposing of leftover medication.

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.

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

The following is the actual transcript of the FDA Podcast:

Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On January 14, 2011, the Food and Drug Administration issued a Drug Safety Communication 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, marketed as 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 can reduce the risk of being hospitalized for these heart problems. Since dronedarone’s 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. Additional usage can occur in the hospital setting.

Dronedarone was approved with a Risk Evaluation and Mitigation Strategy, or 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 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 dronedarone submitted to our Adverse Event Reporting System. 

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 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 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.

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 or 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 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.  

At this time, FDA recommends that Healthcare Professionals:

  1. 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.
  2. 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 will prevent the development of severe liver injury.
  3. Be aware that 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.
  4. In patients who experience hepatic injury without another explanation for the observed liver injury, dronedarone should not be restarted.
  5. Report adverse events involving dronedarone to the FDA MedWatch program at www.fda.gov/medwatch2.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. To learn more about this Drug Safety Communication, go to www.fda.gov/Drugs3. If you have drug questions, you can reach us at: druginfo@fda.hhs.gov.

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 hepatic failure 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.