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).
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.
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.
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.
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.
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.

