Sanders Firm - Wednesday, July 01, 2009 - New York Times

Suicide Warning Issued for 2 Anti-Smoking Drugs

WASHINGTON -- Federal drug regulators warned Wednesday that patients taking two popular stop-smoking drugs should be watched closely for signs of serious mental illness, as reported suicides among the drugs' users mount.

But officials emphasized that patients should not be scared away from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline.

"Stopping smoking is a goal we should all be working towards," said Dr. Curt Rosebraugh, director of a drug evaluation office at the F.D.A. "We don't want to scare people off from trying a medication that could help them achieve this goal. You should just be careful."

The F.D.A. required Pfizer and Glaxo to place so-called black box warnings -- the agency's most serious caution -- on the prescribing information for both drugs. Both companies will be required to conduct clinical trials to assess the mental health risks associated with the drugs' uses.

European officials first alerted the F.D.A. in 2007 to problems associated with Chantix. In September of that year, Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and the New Bohemians, was killed by a neighbor who complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht's girlfriend blamed Chantix, which she said had made him hostile.

The widely publicized event led to a cascade of similar reports and close scrutiny by F.D.A. safety officials, who have now received 98 reports of completed suicides and 188 reports of attempted suicides among those taking Chantix.

As officials looked more closely, they found to their surprise that Zyban has similar associated risks. The agency received 14 reports of suicides and 17 reports of attempted suicides among those taking Zyban.

No one knows why the drugs are associated with mental problems. In some cases, patients could be experiencing nicotine withdrawal, but some of the reports involved patients who had yet to stop smoking. And many of the events happened just as patients began or stopped therapy, officials said.

"If this is nicotine withdrawal, it really doesn't matter," said Dr. Robert Temple, director of a drug evaluation office at F.D.A. "You need to pay attention to them."

Chantix and Zyban join a growing list of medicines that may be associated with suicidal thoughts and behaviors, including anti-depressant, anti-seizure and some antibiotic medicines. Indeed, Zyban and its generic equivalents, known as bupropion, already had a suicide warning on their prescribing labels because of the drug's use as an antidepressant known as Wellbutrin.

In the clinical trial ordered by the F.D.A., manufacturers must assess risks among those with identified psychiatric disorders, because mental health problems are associated with high rates of smoking.

The agency's action requires the drugs' makers to mention the risk of suicide in advertising, and it prevents the companies from conducting "reminder" ads, during which consumers are encouraged to talk to their doctors about a health issue but the product's name is not mentioned.