Oct. 24 (Bloomberg) -- Pfizer Inc.’s smoking cessation drug Chantix doesn’t lead to more hospitalizations than nicotine replacement therapies such Sanofi’s NicoDerm patches, two U.S. studies suggest.
The Food and Drug Administration said today it continues to evaluate the risk of mood changes and other psychiatric events linked to Chantix after releasing the results of two studies the agency cautioned had limitations. Both lacked a large enough sample size to detect rare adverse events or dismiss the increased risk of episodes that don’t result in hospitalizations, the FDA said in a safety announcement.
A boxed warning on Chantix, which works by blocking the effects of nicotine on the brain, cautions patients they could experience changes in behavior, hostility, agitation, depressed mood and suicidal thoughts or actions. New York-based Pfizer, the world’s biggest drugmaker, is conducting a large clinical trial of the drug to assess neuropsychiatric effects, with results expected in 2017, the FDA said.
Chantix was approved in May 2006 and 21.8 million prescriptions were dispensed July 2011, according to the agency.
“We are reviewing this important information for smokers provided by the FDA,” MacKay Jimeson, a spokesman for Pfizer said in an e-mail. “Given the significant public health risks of smoking, Chantix is an important treatment option for adult smokers to help patients stop smoking.”
The FDA sponsored two observational studies with Chantix conducted by the Department of Veterans Affairs and the Department of Defense. Both studies’ showed no statistically significant difference in psychiatric hospitalizations.
The Veterans Affairs study included 14,131 Chantix users and an equal number of nicotine replacement therapy users. Sixteen Chantix-treated patients were hospitalized for psychiatric reasons compared to 21 in the replacement therapy group.
The Pentagon studied 11,978 Chantix users and an equal number of replacement therapy patients. Patients on Chantix were hospitalized 18 times for psychiatric reasons compared to 16 times among replacement therapy patients.
--Editors: Adriel Bettelheim, Angela Zimm
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