The U.S. Food and Drug Administration has announced it is working on adding new labels to 11 epilepsy drugs after previous research has shown they increased patients’ risk of suicidal thoughts and behavior.
The changes will be added to the labels of the following drugs: Carbamazepine ( marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate (Felbatol), Gabapentin (Neurontin), Lamotrigine (Lamictal), Levetiracetam (Keppra), Oxcarbazepine (Trileptal), Pregabalin (Lyrica), Tiagabine (Gabitril), Topiramate (Topamax), Valproate( Depakote) and zonisamide (Zonegran), the Wall Street Journal reports.
The drugs above are also used for migraines, certain nerve-pain disorders and psychiatric diseases like bipolar disorder, which carries itself a risk of suicide.
The changes follow a combined analysis of about 200 clinical trials involving 43,892 patients, which showed that 0.43 percent of the patients treated with these drugs experienced suicidal thoughts or behavior, compared with 0.22 percent of the patients given a placebo.
An FDA advisory panel is scheduled to discuss the new warnings on July 12, but there are speculations they could come sooner than that.
In response to the FDA decision, Pfizer’s vice president, Steve Romano said “there is no signal for suicidality at all in our database.” Pfizer’s epilepsy and pain drug Lyrica had $1.58 billion in sales last year.