Some users of the epilepsy and anti-anxiety drug quinine sulfate—sold under the brand name Trileptal—have developed serious skin disorders and suicidal ideations.
If you or your loved one has taken Trileptal and you believe it caused skin problems or suicide attempts, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. We might be the Trileptal law firm you are looking for.
What Is Trileptal, and What Is It Prescribed For?
Trileptal is the brand name for the drug oxcarbazepine. Made and sold by Swiss pharmaceutical giant Novartis International AG, this drug is used to treat epilepsy in adults and children over the age of four, anxiety, and mood disorders. It has several off-label uses including the treatment of bipolar disorder, schizoaffective disorder, neuropathic pain, and obsessive-compulsive disorder.
Oxcarbazepine is a member of the carboxamide class of anticonvulsants. Carboxamides prevent sodium from conducting through cell membranes, and the net effect is that brain cells release fewer electrical impulses, reducing seizures. Novartis first patented the drug in 1965, and various European countries approved it through the 1990s. The U.S. Food and Drug Administration (FDA) approved Trileptal in 2000. It is still sold in the U.S. in 150mg, 300mg, and 600mg oral tablets.
Novartis has found a winner in Trileptal. It sold Trileptal to at least 250,000 patients, and in 2004 alone sales totaled $391 million. Controversy has surrounded the drug, however. In September 2010, Novartis settled four lawsuits brought by whistleblowers and the Department of Justice for illegally paying doctors kickbacks in the form of speaker programs, advisory boards, entertainment, travel, and meals to prescribe Trileptal to their patients. The settlements cost Novartis $237.5 million, and the four individuals who brought them received a total of $25.6 million in damages. Novartis also pleaded guilty to criminal charges for the same acts and for marketing Trileptal for uses not approved by the FDA.
Trileptal Might Cause Suicidal Ideations and Stevens-Johnson Syndrome
Trileptal has caused severe side effects in some users. One of these is Stevens-Johnson Syndrome (also called Toxic Epidermal Necrolysis [TEN]), a horrific skin condition in which cell death causes the outer layer of skin cells (the epidermis) to separate from the inner layer (dermis). Although it first appears as an upper respiratory tract infection, patients’ skin turns red, fills with fluid, and then peels off. The disease has a high mortality rate; 30-40 percent of victims die due to bacterial or fungal infections.
Like many other epileptic drugs, Trileptal can cause suicidal ideations in some users. The FDA began investigating this phenomenon in 2005, and in 2008 it completed a study of 28,000 people on antiepileptics compared to 16,000 people given placebos. Of those on the antiepileptics, 0.43 percent experienced suicidal ideations. That’s compared to the 0.22 percent of those who experienced suicidal thinking on the placebos. Most of these began within the first week of use and continued for 24 weeks. Neither age nor other demographic subgroups were relevant to the outcome. Four people taking the drugs did commit suicide; none of the placebo-takers did.
The FDA spent much of 2008 considering the studies’ findings and debating whether or not to require a “black box” warning on the product’s packaging. In December 2008 the agency chose not to require a black box warning, but it did require Novartis to warn consumers less conspicuously and develop a “Medication Guide” for users.
The drug is still available on the market and no Trileptal recall has been issued.
RLG’s Lawyers Will Make Things Easier
If you believe you have experienced adverse side effects as a result of taking Trileptal, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Trileptal lawsuit.