Reuters HealthDay reported on February 1, 2008 that the FDA has warned that the anti-smoking drug, Chantix, might contribute to suicidal ideas and behavior.
There's increasing evidence that the smoking-cessation drug Chantix is linked to serious "neuropsychiatric" side effects, including agitation, depressed mood and even suicide, U.S. health officials said Friday.
The U.S. Food and Drug Administration has asked Chantix's manufacturer, Pfizer Inc., to make the warning about these potential problems more prominent on prescribing information and on the drug's label. The agency is also working with Pfizer to produce a Medication Guide for patients, officials said.
"We have become increasingly concerned as we have seen a number of compelling cases that truly look as if they are the result of exposure to the drug and not to other causes," Dr. Bob Rappaport, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products, said during an afternoon teleconference.
"These cases involve abnormal behaviors, changes in mood, and suicidal ideation and suicide," Rappaport said.
The FDA knows of 491 cases of suicidal behavior associated with Chantix, said Dr. Celia Winchell, a team leader in the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.
"Of these, 420 are from the United States," Winchell said. "There are 39 that involve completed suicides, 34 in the United States."
According to Pfizer, 5 million patients have taken Chantix, whose generic name is varenicline.
Friday's warning follows a Nov. 20 FDA statement that the agency was "evaluating post-marketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior."
At that time, Pfizer said there had never been a cause-and-effect relationship shown between Chantix and these symptoms. The company also said that part of the problem may be due to nicotine withdrawal.
Pifzer who manufactures and markets Chantix says that part of the agitation and suicidal ideas might be linked to nicotine withdrawal. One thing seems clear, and cigarettes are a huge risk factor for premature death so stopping smoking, even with the use of Chantix, is well worth any minimal risk.