In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them.  Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs.  The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning.

A black-box warning is the strongest warning of danger available to the pharmaceutical industry.  Instead, the panel approved sending medication guides to physicians that describe the increased risk of suicide posed by these medications.

The panel said the risk of suicide wasn’t high enough to warrant the black-box warning and that to allow it might deter physicians from prescribing it.  The opinion of the panel is taken very seriously by the FDA and the agency usually follows its recommendations.

The drugs in question include both the brand name and the generic name of Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate, Gabapentin (Neurontin), Lamotrigine (Lamictal), Levetiracetam (Keppra), Oxcarbazepine (Trileptal), Pregabalin (Lyrica), Tiagabine (Gabitril), Topiramate (Topamax), Valproate (Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (Zonegran).  These drugs are often prescribed to treat epilepsy, migraine headaches, bipolar disorder, and several other conditions.

While the FDA does not think there is reason to alter or interrupt treatment if a patient is taking any of these medications, they do advise caregivers to pay special attention to changes in mood, behavior, and the actions of the individual patient.