FDA to review stop-smoking drug Chantix
The Food and Drug Administration (FDA) announced Friday that a panel of psychiatric drug experts will be gathering at a public meeting in October to discuss the side-effect risks of the smoking cessation drug Chantix.
In 2009, the government gave Chantix the strongest warning label, the “black box” label, after the FDA received hundreds of reports that people taking the drug were exhibiting suicidal behavior, some of whom actually committed suicide while on the stop-smoking drug.
Side effects of Chantix include the risk of agitation, depression, hostility and suicidal thoughts.
The drug comes from Pfizer, which states on the label that patients should stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes.
Physicians are also advised to exercise caution by comparing the drug’s risks versus its benefits before prescribing to patients who want to stop smoking.
Pfizer recently submitted new data to the FDA, which assessed the drug's safety to placebo and other anti-smoking techniques, according to a spokesperson for the drug company on Friday.
SOURCE: Food and Drug Administration (FDA), Federal Notice, October 16, 2014: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement, published April 24, 2014