The U.S. Food and Drug Administration (FDA) believes that the anticonvulsant drug carbamazepine—sold under numerous brand names, including Carbatrol, Equetro, and Tegretol, and under generic names as well—causes dangerous skin reactions and suicidal ideations and behaviors.
What Is Carbamazepine? When Is It Prescribed?
Carbamazepine is the chemical name of an old anticonvulsant drug. Several companies sell brand name versions of the drug: Carbatrol (Validus Pharmaceuticals, Inc.), Equetro (Shire Phramaceuticals), and Tegretol (Novartis). The FDA has approved it to treat bipolar I disorder, epilepsy, and trigeminal neuralagia, and it is often sold in oral tablets.
Carbamazapine is a member of the carboxamide class of anticonvulsants. Carboxamides prevent sodium from conducting through cell membranes, with the effect that brain cells release fewer electrical impulses, reducing seizures. A chemist at Swiss pharmaceutical company Novartis AG discovered the usefulness of the drug in 1953. Pharmaceutical companies first used it to treat trigeminal neuralgia, and in early 1971 Japanese doctors began prescribing it for epilepsy and bipolar disorders.
Potential Carbamazepine Side Effects Include Stevens-Johnson Syndrome and Suicidal Ideations and Behaviors
Carbamazapine causes severe side effects in users. One of these is Stevens-Johnson Syndrome (a form of 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.
Suicidal Ideations and Behaviors
Like many other epileptic drugs, Carbamazapine causes suicidal ideations in 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. About 0.43 percent of those on the antiepileptics experienced suicidal ideations as opposed to 0.22 percent of those 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. In the summer, it debated requiring a “black box” Carbamazapine warning on the its packaging. In December 2008 it chose not to require the Carbamazapine warning, but it did require Novartis, Validus Pharmaceuticals, Shire Pharmaceuticals, and the others to warn consumers less conspicuously and develop a “Medication Guide” for users.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Carbamazepine lawsuit on your behalf if necessary.
If you have taken Carbamazepine and believe it harmed you, contact RLG today.