A panel of outside experts is set to meet on July 10 to
advise the FDA on how best to communicate to consumers elevated risks of suicidal thoughts and behavior associated with epilepsy medications. At the end
of January the FDA warned healthcare providers of the increased risks.
According to FDA spokesperson Sandy Walsh, further review of the data has
confirmed a doubled risk of suicide and suicidal ideation associated with 11
epilepsy drugs and the agency now believes that all members of this class of
medicines share the risks.
Products included in the review are
Pfizer’s Neurontin and Lyrica, J&J’s Topamax, GlaxoSmithKline Plc’s
Lamictal, Meda AB’s Felbatol, UCB SA’s Keppra, Novartis AG’s Trileptal, Cephalon
Inc.’s Gabitril, Abbott Laboratories’ Depakote, Eisai Co.’s Zonegran, and
carbamazepine, sold by several drugmakers.
Drugmakers have expressed
reluctance to accept the findings as truth claiming that the studies are flawed
because they group data from several different medications. The panel will
likely recommend adding the agency’s strongest, “black box,” warning to the
label of these medications. The FDA is not required to follow the advise of
outside panels but almost always does. Only time will tell what the future hold
for these medications.