The FDA issued a sobering warning yesterday: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Millions are--they're prescribed not only for the seizure disorder but for pain and psychiatric illnesses. The 11 drugs affected include such big-name meds as Pfizer's Lyrica, Abbott Laboratories' Depakote and OrthoMacNeil's Topamax.
Before issuing the warning, the FDA reviewed 199 studies on the meds, finding that the risk of suicide-related events in patients taking the drugs, while low, were still significantly higher than those taking placebo. Patients starting therapy with one of the meds should be watched carefully for signs of suicidal behavior, the agency said. Warnings about the risks will be included in the drugs' labels.
Though all the drug makers involved could see sales drop, the company that stands to lose most, according to the San Francisco Chronicle, is Pfizer. That company has nearly a thousand lawsuits pending over the suicides or attempted suicides of patients taking Neurontin. Many of the patients were prescribed Neurontin off-label, during a period when a Pfizer unit was promoting it for use in bipolar disorder, migraine headaches, and other ailments--all uses not approved by the FDA. In fact, the FDA's review of the epilepsy drugs was prompted by an attorney's request.
- check out the release from the FDA
- see the San Francisco Chronicle's article