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FDA reviews psychiatric side effects of Chantix

Published on NewsOK Modified: April 25, 2014 at 4:36 pm •  Published: April 25, 2014

WASHINGTON (AP) — The Food and Drug Administration announced Friday it will hold a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's anti-smoking drug Chantix.

The agency said in a federal notice it will convene its panel of psychiatric drug experts to discuss the pill's risks and how to best manage them.

Since 2009 Chantix has carried the government's strongest safety warning — a "black box" label — because of links to hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicide and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug.

At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the side effects.

A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA designed to establish the drug's safety compared with placebo and other anti-smoking therapies.

"Pfizer has proposed an update to the Chantix labeling based on these new data, which, we believe, would better reflect the product's safety profile as it pertains to neuropsychiatric symptoms," said Victoria Davis, in a statement.

The New York drugmaker's FDA submission includes data pooled from multiple Pfizer studies along with studies conducted by the U.S. Department of Defense and the Department of Veterans Affairs. The two federally-funded studies, released in 2011, did not show an increased rate of psychiatric hospitalizations among more than 26,000 Chantix patients when compared with patients using nicotine patches and other smoking cessation treatments. The studies only recorded psychiatric problems that resulted in hospitalization, meaning many issues likely went unreported, according to the authors.

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