In April 2008, Juan Morales was prescribed Dilantin and Phenytoin, both made by Mylan Pharmaceuticals. Morales says he sought medical treatment after he developed a rash on 80 percent of his body. He was given another prescription to treat the rash and sent home. However, the rash continued to get worse and on May 22, 2008, he was admitted to Corpus Christi Medical Center and treated for SJS. He was told it was caused by his medications.

SJS is a life threatening reaction to medication. More than 2,000 prescription and over-the-counter drugs have been linked to SJS. The condition begins with a rash that blisters over causing the skin to peel off in sheets. Patients with SJS are often treated in burn units. The painful condition can expose the body to infections. Blisters can also form on the internal organs and eyes leading to dehydration, digestive problems and vision disorders.

Morales claims had he known the risks associated with taking Dilantin and Phenytoin he would not have taken the medications. His lawsuit claims Mylan Pharmaceuticals knew of the dangers but failed to remedy the defects. Morales is seeking compensatory and punitive damages.

SOURCE: Stevens Johnson Syndrome › Texas man sues drug maker after suffering serious skin reaction

Ralph was rushed to Miami Valley Hospital in Dayton and was diagnosed with toxic epidermal necrolysis, or TEN. TEN is a severe form of the hypersensitivity disorder known as Stevens Johnson Syndrome, or SJS. The condition occurs as a severe reaction to medication and presents as a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes such as those on the eyes and in the mouth also can blister over. Complications include infection, dehydration, blindness and even death.

Phenytoin, made by Mylan Pharmaceuticals and sold under the name Dilantin, was listed as the culprit.

Ralph never recovered. He died on May 27, 2006, from TEN. Amy has since filed a lawsuit against the Mylan Pharmaceuticals and Mylan Inc., on behalf of the estate of her late husband Ralph. Amy says her husband would not have taken the drug had he known of the potential for serious side effects.

The 10-count lawsuit claims the drug maker repeaed huge profits while concealing from the public the dangers of taking Dilatin/Phenytoin. The lawsuit seeks punitive and compensatory damages for Ralph’s injuries, pain and suffering. It also seeks damages to Ralph’s estate.

SOURCE: Stevens Johnson Syndrome › Wife files lawsuit against drug maker

In a recent Information for Healthcare Professionals sheet, the FDA described the increased risk of SJS/TEN with another antiepileptic drug, carbamazepine, in patients of Asian ancestry with the HLA-B*1502 allele. HLA-B is a human gene that provides instruction for making a protein that plays a critical role in the immune system. It is part of a family of genes called the human leukocyte antigen (HLA) complex. This complex helps the immune system distinguish the body’s own proteins from proteins made by viruses or bacteria. Several variations of the HLA-B gene are associated with adverse reactions to certain drugs.

SJS is a disorder of the skin and mucous membranes and often begins with flu-like symptoms followed by inflammation of mucous membranes and a painful red or purplish rash that spreads and blisters. It eventually causes the top layer of skin to die and shed.

Until the FDA completes its review, the agency warns healthcare providers who are considering the use of phenytoin or fosphenytoin for their patients to be aware of the risks and benefits described in the current prescribing information for the drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

SOURCE: Stevens Johnson Syndrome › FDA warns of link between anti-epilepsy drugs and SJS