FDA: Chantix doesn't boost risk of psych hospitalization

Pfizer CEO Ian Read--courtesy of Pfizer

Chantix apparently doesn't boost the risk of psychiatric hospitalization, but it still needs that "black box" warning of psychiatric side effects, the FDA says. After reviewing two studies that compared the Pfizer ($PFE) stop-smoking drug with standard nicotine replacement therapy, the agency said those persons on Chantix were no more likely to be hospitalized for psychiatric complaints than the nicotine-patch patients were.

But the studies had limitations--for instance, they focused only on psychiatric problems requiring a hospital stay--and so the agency said it would keep the "black box" warning on Chantix's label. "Overall, FDA has determined that the current warnings in the Chantix drug label, based on postmarketing surveillance reports, remain appropriate," the agency said in a statement.

Pfizer is in the midst of its own large-scale trial examining the risk of psychiatric trouble in Chantix patients, as Reuters points out. Results of that study won't be forthcoming until 2017, however. The two studies FDA examined weren't big enough to flag rare psychiatric side effects, the agency said; one involved about 28,000 patients and the other comprised some 36,000 patients.

FDA is still on alert to the potential risk of mood disturbances and suicidal thoughts with Chantix therapy, Bloomberg reports. As for Pfizer, a company spokesman told the news service, "[w]e are reviewing this important information for smokers provided by the FDA. Given the significant public health risks of smoking, Chantix is an important treatment option for adult smokers to help patients stop smoking."

- read the FDA statement
- get more from Reuters
- see the Bloomberg coverage