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Pfizer, Glaxo Smoking Pills Get Warning on Suicides (Update2) 

Pfizer Inc. and GlaxoSmithKline Plc’s quit-smoking treatments must carry the strictest U.S. warning about psychiatric side effects, including the risk of suicide.

The Food and Drug Administration is adding the warnings, which will be highlighted in a black box, to the prescribing information of Pfizer’s Chantix and Glaxo’s Zyban. The agency has received a combined 317 reports of suicides and attempted suicides among patients taking the drugs, said Curtis Rosebraugh, director of the FDA’s Office of Drug Evaluation II, in a conference call today with reporters.

Pfizer said it stands by the safety of Chantix and Glaxo said it doesn’t believe there is enough evidence to prove a link. The FDA warned in January that Chantix may increase the risk of suicide or erratic behavior, and the Federal Aviation Administration banned its use in pilots. Chantix sales plunged 36 percent to $177 million in the first quarter, Pfizer said.

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