Trileptal Stevens Johnson Syndrome risk will now extend to generics
The FDA announced this week the approval of a generic form of Trileptal, which will be distributed by pharmacists under the name oxcarbazephine. Trileptal side effects have previously been associated with an increased risk of developing the painful and possibly fatal skin disorders, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis Syndrome (TENS).
Trileptal is an anticonvulsant drug used to treat partial and complex seizures in adults and children as young as 4 years old. It is also commonly used “off-label” to treat bipolar disorder, OCD, schizoaffective disorder and neuropathic pain. In 2006, it was the 74th best selling drug in the United States.
In April 2005, the FDA and the manufacturer of Trileptal, Novartis Pharmaceuticals, updated the warnings and precautions sections of the prescribing information of the drug to warn about the increased risk of SJS and TENS. The serious skin reaction has been observed in both adults and children and the Trileptal reporting rate of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis is 3 to 10 times higher than the background incidence rate estimates.
SJS and TENS are two similar skin disorders which can cause the skin to burn from the inside out. Mucous membrane areas, such as the eyes, mouth, anus and genitalia can become inflamed, eventually causing raised legions which can rupture leaving the skin below exposed. The extremely painful condition often requires treatment in an intensive care unit (ICU) or the burn unit of a hospital, and in some severe cases it is fatal.
Early signs of SJS and TENS could include a body ache and headache which often un-noticed as signs of a serious oncoming disorder. If SJS/TENS is not diagnosed and treated quickly, it can grow rampant, causing the body to lose as much as 30% of the skin. The FDA announcement of the generic Trileptal indicates that the serious skin reactions have been associated with Trileptal and that immediate medical attention should be sought if any reaction occurs after taking the brand name drug or the new generic.
Stevens Johnson Syndrome lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals diagnosed with SJS or TENS. The only known cause of SJS and TENS is a reaction to prescription medications. However, Trileptal and several other medications appear to carry a significantly increased risk and many individuals have not been provided with adequate warnigngs about the risk of SJS and TENS.
If you, a friend or family member have been diagnosed with Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis Syndrome (TENS), financial compensation may be available through a Trileptal lawsuit. Request a free claim evaluation.
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