Agency Investigating Dilantin Risks of SJS and TEN

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found on the FDA’s website.

SOURCE: U.S. Food and Drug Administration (FDA)

Dilantin lawsuit information: Dilantin Lawsuits

Dilantin SJS information: Dilantin Stevens Johnson Syndrome Lawsuits

Dilantin TEN information: Dilantin Toxic Epidermal Necrolysis Lawsuits

See also: Dilantin Side Effects.

Speak to a Dilantin Lawyer

If you took Dilantin and suffered Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), we encourage you to contact a Dilantin attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Dilantin. Contact our law firm and learn more about your legal rights and the options available to you and your family.

Updated: July 23, 2010 — Patients taking Dilantin, or Dilantin XR, need to be aware of serious skin side effects. The FDA has warned of a potential increased risk of severe skin reactions including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) from phenytoin therapy. Epileptic patients taking Dilantin to control seizures should be aware of these health risks. Dilantin (phenytoin sodium) is an anti-epileptic drug, sometimes also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Doctors prescribe Dilantin (phenytoin sodium) to patients with certain forms of epilepsy to manage temporal lobe seizures (a type of seizure caused by disease in the cortex of the temporal [side] lobe of the brain affecting smell, taste, sight, hearing, memory, and movement) and grand mal seizures (a type of seizure in which the individual experiences a sudden loss of consciousness immediately followed by generalized convulsions). Dilantin may also be used to prevent and treat seizures that can occur during and after neurosurgery (surgery of the brain and spinal cord).

Dilantin Stevens Johnson Syndrome (SJS)

Stevens Johnson Syndrome is a rare and serious disease that affects the mucous membranes and the skin, eventually resulting in the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). SJS is closely related to TEN (Toxic Epidermal Necrolysis), which affects the skin in the same way but can lead to the separation of one hundred percent of the epidermis. SJS is said to be a milder form of TEN, affecting up to thirty percent or more of the epidermis. SJS has been linked to many prescription medications and a multitude of common over-the-counter treatments as well. Stevens Johnson Syndrome is similar to Lyell’s Syndrome.

For more Dilantin SJS information, see also: Dilantin Stevens Johnson Syndrome Lawsuits

Dilantin Toxic Epidermal Necrolysis (TEN)

Toxic Epidermal Necrolysis (TEN), also known as Lyell’s Syndrome, is said to be a more severe form of Stevens Johnson Syndrome with mortality and morbidity rates that are much higher than SJS. Like SJS, TEN & Lyell’s Syndrome are immune complex-mediated hypersensitivity complexs that are a severe expression of erythema multiforme and involve the skin and mucous membranes. Again, as with SJS, there is significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes in Toxic Epidermal Necrolysis (TEN).

For more Dilantin TEN information, see also: Dilantin Toxic Epidermal Necrolysis Lawsuits

FDA Investigates Dilantin Risks of SJS and TEN

The FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy. For more FDA Report information, read: FDA Dilantin Investigation

Speak to a Dilantin Lawyer

If you took Dilantin and suffered Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), we encourage you to contact a Dilantin attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Dilantin. Contact our law firm and learn more about your legal rights and the options available to you and your family.

The Yaz birth control pill could be putting millions of young women at risk of serious side effects, including stroke, heart attack and even death. Bayer USA, the maker of Yaz, has already been warned by the Food & Drug Administration (FDA) for running TV commercials that minimize the potential health consequences of Yaz.

In the summer of 2009 several lawsuits were filed by women who claimed Yaz made them ill. The lawsuits allege Bayer overstated the benefits of Yaz and failed to warn that it could put women at risk of serious injury. It is expected that similar Yaz lawsuits will be filed in the near future.

Yaz Birth Control Pill

Yaz is a combination birth control pill for women that contains both estrogen and progestin. Yaz is considered a low-dose pill because it contains no more than .035 milligrams of estrogen.

Yaz received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in October 2006. Finally, in January 2007, Yaz was approved to treat moderate acne in women who desire an oral contraceptive for birth control.

Yaz is one of the best-selling oral contraception pills in the United States, with sales of $616 million in 2007.

Yaz Side Effects

Evidence is growing that Yaz carries serious health risks. Yaz contains a synthetic type of progestin called drospirenone. According to the FDA, drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients. This condition may result in potentially serious heart and health problems.

Because of this risk, women with conditions that predispose them to hyperkalemia (such as renal insufficiency, hepatic dysfunction and adrenal insufficiency) should not take Yaz. Women taking Yaz must also be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.

In order for Yaz users to avoid high potassium levels, blood tests should be drawn every few months. Most women who take Yaz don’t know about taking these blood tests because the instructions to take the tests are given in a small package insert with the birth control – something few people ever read.

Women involved in Yaz lawsuits have claimed that they suffered from a variety of serious ailments. These Yaz side effects include deep vein thrombosis, pulmonary embolism, and stroke. Yaz has also allegedly been associated with heart attacks and deaths in young women.

Finally, the FDA’s Adverse Event Reporting System (AERS) lists a variety of other side effects reported by Yaz users. These include severe allergic reactions, rash, hives, itching, difficulty breathing, chest tightening, fainting, irregular heartbeat, liver problems, unusual or severe vaginal bleeding, unusual tiredness or weakness, vaginal irritation or discharge, and vision changes.

Patients with constant pain after hip implant surgery may need to speak with their doctor to see if the hip implant has failed. Failed hip implants include any hip implant that has broken, come loose or caused other hip surgery related problems. According to most experts, temporary pain or discomfort after a hip implant surgery is normal and not suggestive of a broken hip implant, femoral head or socket. However, a sudden pain in the implanted hip joint, sometimes preceded by an audible “pop” from the hip just before the onset of pain, is a signal of a hip implant fracture or failure.

Zimmer Durom Cup Hip Implant Failures

Problems with the Durom cup became known in April when a Los Angeles surgeon, Dr. Lawrence Dorr, publicly warned other orthopedists about Durom cup failures he was hearing about from his patients. At that time, Zimmer said it would initiate an investigation but that it saw no reason to take other action, such as halting sales. Zimmer cited European data that indicated that the Durom cup was doing well there; however, the version of the Durom cup used outside the U.S. is a bit different from the one used in the United States. Additionally, while U.S. doctors use the Durom cup in traditional hip replacement surgeries, surgeons in other countries use the device in a relatively new kind of hip surgery known as resurfacing, which involves different surgical techniques.

Hip Implant Fractures and Defective Hip Implants

If a hip implant fractures, surgery to replace it will be necessary. Currently, no tests exist that can predict which patients will experience failure of their hip implants. Patients with recalled hip implants should be closely monitored by their doctors.
Some Zimmer hip implant patients are suffering from what has been described as Zimmer hip pain. Pain in the area of where a hip replacement has been done may indicate a faulty hip implant, loose hip implant, broken hip implant or defective hip implant. Zimmer hip implant patients who are concerned that they may have received a defective artificial hip are urged to contact their orthopedic surgeons or the hospital where their Zimmer hip replacement surgery took place. Concerned patients should request their surgery records from the hospital ’s medical records department to find out if a Zimmer Durom cup hip implant was used in their hip replacement surgery.

NOTE: If you are required to have replacement surgery, tell your Doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against Zimmer.

The drug manufacturer Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The defective drug is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a serious risk of digitalis toxicity in patients with renal failure. Symptoms of digitalis toxicity include: nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported to the FDA. Patients should contact their healthcare professional with questions regarding this medication.

Evidence is emerging to suggest that patients need to be alert to the fact that combining nonsteroidal anti-inflammatory pain medications (NSAIDs) such as ibuprofen (ADVIL) and naproxen (ALEVE) with a class of osteoporosis drugs called bisphosphonates, such as alendronate (FOSAMAX), etidronate (DIDR¬ONEL), ibandronate (BONIVA) and risedronate (ACTONEL) may result in an increased risk of ulcers and other gastrointestinal side effects and complications.

In the article, “Preserving Bones with Bisphosphonates: Should You Avoid NSAIDs?”- Worst Pills Best Pills, one randomized study of 26 healthy subjects looked for stomach ulcers in people who were given three short-term (10-day) treatments with alendronate, naproxen, and both together. Subjects were given all treatments with a one-to four-week washout between each. Eight percent of the people who took alendronate alone developed a stomach ulcer, and 12 percent of patients who took naproxen alone also developed a stomach ulcer. The study found that 38 percent of patients who took the two drugs together developed a stomach ulcer. There was a dramatic increase in the risk of stomach ulcers, demonstrating what is called synergism between the two drugs.

A larger study also examined the medical records of 242 patients who had received NSAID therapy for rheumatoid arthritis over a three-month period and found that over 30 percent of the patients receiving bisphosphonates along with their NSAID therapy had developed gastrointestinal ulcers, compared to 17 percent in those who received NSAIDs alone.

PriCara Recalls 25 mcg/hr Duragesic (Fentanyl Transdermal System) CII Pain Patches

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that 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 are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.

Fentanyl Gel Leaks

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 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. 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. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. 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. Keep defective fentanyl patches away from children and animals and do not dispose of them until you have spoken to an 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 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.

Duragesic patches sold in Europe, Latin America and Asia are not affected by this recall.

Fosamax (alendronate sodium) is an osteoporosis drug manufactured by Merck to treat bone loss. Fosamax, which belongs to a class of drugs called bisphosphonates, has been prescribed to millions of patients to increase bone density and reduce the risk of fractures. A significant number of Fosamax lawsuits have been filed on behalf of patients who experienced severe side effects from taking Fosamax. These side effects included a rare decay of the jawbone known as osteonecrosis of the jaw, or ONJ.

There have been published reports since 2003 documenting a possible link between bisphosphonates and osteonecrosis of the jaw, or “dead jaw”, a condition marked by pain, swelling, infection and/or exposed bone. Often times osteonecrosis of the jaw involved patients with cancer who were receiving chemotherapy and had been given intravenous bisphosphonates to treat cancer that had spread (metastasized) to the bone. However, a number of cases of osteonecrosis of the jaw have also been reported in people taking oral bisphosphonates such as Fosamax for osteoporosis.

The risk of developing osteonecrosis of the jaw due to bisphosphonate use is significantly higher in people with cancer or dental problems. If you currently take an oral bisphosphonate and need a dental procedure, you should discuss this with your doctor, dentist and oral surgeon. Most notably, osteonecrosis of the jaw has been associated with a recent dental procedure, such as a tooth extraction or active dental disease.

Osteonecrosis of the jaw is a very serious disorder. However, if a person has been prescribed bisphosphonate for osteoporosis, they should not stop taking the medication without first consulting their doctor.

Speak to a Fosamax Lawyer

If you took Fosamax and suffered osteonecrosis of the jaw (ONJ), a broken leg, or femur fracture, we encourage you to contact a Fosamax attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Fosamax. Contact our law firm and learn more about your legal rights and the options available to you and your family.