The Road to Stiffer Suicide Warnings for Chantix and Zyban
The FDA announcement today that smoking-cessation drug Chantix should require a boxed warning about the risk of serious mental-health symptoms isn’t particularly surprising.
The Pfizer drug has been investigated by U.S. and European regulators since 2007 for concerns about suicide risks and other events like blackouts. Since that time, Pfizer has beefed up warnings on the drug’s label, the U.K. has issued a warning letter about its connection to suicide and the FAA banned its use in pilots and air-traffic controllers. As a result, Chantix sales — which Pfizer had once called its fastest drug launch ever — have rollercoastered. U.S. Chantix sales decreased 30% in 2008 to $489 million compared with 2007.
Unexpectedly, today’s FDA action also affects another smoking-cessation drug, GlaxoSmithKline’s Zyban. Curt Rosebraugh, director of the FDA’s Office of Drug Evaluation II, said that initially Zyban and nicotine-replacement patches served as comparisons to Chantix, but investigators noticed that “the characteristics of the reports [with Zyban] seemed to be the same as with Chantix,” Rosebraugh said during a news briefing.
Zyban is also marketed as an antidepressant known as Wellbutrin, and there have been concerns over the link between antidepressants and suicide in kids and adolescents.
Today’s boxed warning highlights concerns […]
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