The U.S. Food and Drug Administration’s recommendation to
add a “black box” warning to some 11 epilepsy drugs letting patients know about
the risk of suicidal thoughts or behavior was not approved by a
The reason they gave was that this black box warning, the
FDA’s sternest warning, would scary epileptic patients up to the point of
denying treatment.
The FDA announced it was considering a black box warning in late January after an analysis of the agency involving 199 studies showed that 0.43 percent of patients on epilepsy drugs committed suicide or thought about doing so, compared with 0.24 percent of patients on a placebo.
The
drugs targeted by the black box request involved top-selling GlaxoSmithKline
PLC’s Lamictal and Pfizer Inc’s Lyrica. Other names included Johnson &
Johnson’s Topamax, Abbot Laboratories Inc’s Depakote, Pfizer’s Neurontin,
The FDA’s review found that only 8 of the 11 drugs showed an
increased risk of suicide, while three did not. However, the agency wanted
black box warnings for all of them, a request the advisory panel refused.
Rochelle Caplan, MD, a professor of psychiatry at University
of California Los Angeles and a member of the expert panel said “we have to be
careful about scaring the patients into not taking these drugs, and I think we
have to be very thoughtful about that,” WebMD reports.
According to Dr. Russell Katz, director of the division of
neurology products at the FDA’s Center for Drug Evaluation and Research 14
members of the panel voted against the black box warning, four voted for the
warning and three abstained.
Although the panel’s members were against the black box warning,
they voted in favor of sending a medication guide to physicians highlighting
the increased risk of suicide in some patients.
More than 10 million Americans took FDA-approved epilepsy drugs in 2007.