More FDA Demands

The FDA decided in December to require the manufacturers of antiepileptic drugs to add warnings to their package inserts that the drugs use may increase the risk of suicidal thoughts and behaviors.

The FDA will also require that the pharmaceutical companies submit a Risk Evaluation and Mitigation Strategy for each product and a patient medical guide, which will contain "FDA-approved information" about the risk of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

The following is the list of antiepileptic drugs that are required to add warnings:

• Carbatrol


• Klonopin


• Tranxene


• Depakote


• Zarontin


• Peganone


• Felbatol


• Neurontin


• Lamictal


• Vimpat


• Keppra


• Mesantoin


• Celontin


• Trileptal


• Dilantin


• Lyrica


• Mysoline


• Banzel


• Gabitril


• Topamax


• Tridione


• Depakene


• Zonegran

Physicians have concerns about the new labeling demands but there really is not much they can do about it.