December 16, 2008
FDA requires suicide warning on some drugs
The U.S. Food and Drug Administration says it will require suicide warnings on all anti-epileptic drugs, including those used to treat other conditions.
The federal agency says the warning about the risk of suicidal thoughts and suicidality will be required on all anti-epileptic drugs that are also used to treat psychiatric disorders, migraine headaches and other conditions. The warnings will appear on all prescribing information or labeling.
Patients being treated with anti-epileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, said Dr. Russell Katz, director of the FDA's Division of Neurology Products. He noted patients currently taking an anti-epileptic medicine should not make any treatment changes without talking with their healthcare professionals.
Included among the anti-epileptic medications are the brand names Carbatrol, Equetro, Tegretol, Tegretol XR, Klonopin, Tranxene, Depakote, Depakote ER, Depakene, Zarontin, Peganone, Felbatol, Neurontin, Lamictal, Vimpat, Keppra, Mesantoin, Celontin, Trileptal, Dilantin Suspension, Lyrica, Mysoline, Gabitril, Topamax, Tridione and Zonegran.
Some of the medications are also available as generics.