FDA to Convene Panel on Smoking Cessation Drug, Chantix, Over Psychiatric, Behavioral Side Effect Risks

fda_reviews_side_effects_of_ChantixThe U.S. Food and Drug Administration (FDA) announced that it plans to review Chantix, the smoking cessation drug, to determine if its quit smoking benefits exceed its psychiatric and behavioral risks,

Approved in 2006, Chantix received the U.S. Food and Drug Administration’s (FDA) Black Box label warning in 2009, the agency’s most serious, according to Medical Daily. The FDA indicated that it will convene a psychiatric drug expert panel to discuss side effects associated with Chantix.

Chantix has been associated with psychiatric side effects since its release, including dozens of reports of suicides and hundreds of reports of suicidal behavior, according to Medical Daily. In 2009, the year the Black Box label was mandated by the FDA, the agency also required that Pfizer, the manufacturer of Chantix, conduct more studies to gain a clearer understanding of the drug’s dangerous side effects.

Pfizer spokeswoman, Victoria Davis, announced that the drug firm just sent new data to the agency that compared Chantix’s psychiatric safety to a placebo and other anti-smoking methods. “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,” Davis wrote in a statement, according to an ABC News report. A public meeting is planned for October to discuss the new information, wrote Medical Daily.

Chantix is a pill that is taken twice daily and that is advertised to help users quit smoking. Chantix works by blocking the pleasurable effects of smoking in the brain, which decreases the desire to smoke. The drug is also meant to be used in collaboration with behavior modification and counseling, according to Medical Daily.

The most common side effects associated with Chantix include, abnormal dreams, trouble sleeping, unusual tiredness, and weakness. The Chantix website also lists other possible side effects that include, “hostility, agitation, depressed mood, and suicidal thoughts or actions,” Medical Daily reported.

Meanwhile, Chantix has been the focus of a murder case that involves a man who is standing trial for the murder of his wife. At the time of the crime, the man was also suffering from depression and his defense attorney has associated his depression with his having been taking Chantix prior to the crime. The judge permitted the so-called “Chantix defense” to be used, Medical Daily wrote.

The drug’s labeling advises patients to cease taking Chantix immediately if agitation, depressed mood, suicidal ideation, or other behavioral changes are experienced, according to NBC News. Doctors are advised to weigh the Chantix risk-benefit profile prior to prescribing the drug to patients for smoking cessation assistance.

This entry was posted in Chantix, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.