Contaminated drug lawyers at Pintas & Mullins Law Firm report that the popular anti-seizure drug Dilantin is associated with development of Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The diseases are caused by Phenytoin, an ingredient in Dilantin.
The drug has also been classified by the FDA as a category D medication for pregnant women. The D classification means there is substantial evidence that the drug will cause severe harm to a fetus if it is taken during pregnancy. Children may be born with major cognitive and developmental problems, particularly in malformation of the brain or spinal cord. Other major birth defects include cleft lips or palates, heart defects, and fetal hydantoin syndrome.
Dilantin was approved by the FDA in 1953, and was the first modern drug intended to treat seizures. Alarmingly, reports of SJS induced by Dilantin were released as early as the 1930s, although the drug is currently one of the most widely prescribed anti-seizure medications in the US. SJS is a life-threatening skin disease, and initial symptoms may include fever, sore throat, and headache. The disease progresses into skin lesions and blisters around the mouth, throat, eyes, genital tract, and intestines. If it is not treated right away, SJS causes the skin to fall off in large chunks, such as in a severe burn. SJS patients are frequently treated in burn units, and many claim the disease is even beyond third-degree burns.
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SJS is estimated to be fatal in about 15% of cases. Deaths occur if the skin lesions become infected, or if patients develop lesions in the lungs. Stanford Hospital estimates that one in ten thousand Dilantin patients suffer a serious SJS reaction. It can also cause blood and liver toxicity, worsening of seizures, and toxic doses. Risk of liver toxicity is increased in elderly patients and those who are gravely ill.
SJS often leads to TEN developments, which occurs when 30% or more of the body’s skin is burned off. TEN is an emergency medical condition that almost always requires immediate hospitalization. The condition causes skin to deteriorate and detach from the body, especially on the back. Patients at risk of developing SJS and TEN often first produce an unexplained rash.
Dilantin controls seizures by slowing down brain impulses and reducing the maximum activity of brain stem cells responsible for seizures. The drug is also known to increase the risk of suicidal thoughts and behavior. One analysis showed that those taking antiepileptic drugs, including Dilantin, were twice as likely to have suicidal thoughts or behavior as those taking a placebo. Four patients committed suicide during the trial, all of whom were prescribed to Dilantin or another antiepileptic drug.
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The drug is also used in emergency rooms to prevent seizures in patients who have experienced a head injury, and, in some cases, to treat severe headaches. In a 2008 Health Alert, the FDA cited that Dilantin had an increased risk of SJS and TEN in patients with Asian ancestry. Other patients at higher risk for SJS and TEN include African Americans, those with a family history of the syndromes, and immuno-suppressed patients. African and Asian Americans are particularly susceptible because of a specific gene that stimulates the immune system into overdrive when the drug is metabolizing. This destroys healthy skin cells at an incredibly rapid pace.
The drug is manufactured by Pfizer, which has been subject to hundreds of Dilantin lawsuits in the past few years. In 2011, for example, the family of a child received a $3.78 million settlement against Pfizer after their daughter, a nine-year-old, died after taking Dilantin for under one month. Eight other companies manufacture generics of Dilantin, including Mylan Pharmaceuticals and Baxter Healthcare.
Product liability lawyers at Pintas & Mullins Law Firm point out that SJS and TEN are caused by pharmaceuticals. The legal theory is that Pfizer and other drug companies knowingly concealed the increased risk of TEN and SJS development from American consumers, and victims are demanding compensation for their suffering.