The U.S. Food and Drug Administration (FDA) never fully reviewed the safety of the smoking-cessation drug Chantix.

The agency “fast-tracked” its initial 2006 review of the medication (which is generically called varenicline, and is marketed by the pharmaceutical company Pfizer), learning only after the drug’s release that its now-well-known side effects include hostility, agitation, depressed mood and suicidal thoughts or actions. 

The FDA this month added to that list “cardiovascular adverse events”—including heart attack. A clinical trial of smokers with cardiovascular disease who were treated with Chantix or placebo found that cardiovascular adverse events occurred more frequently in patients treated with Chantix than in those treated with placebo. After reviewing the study findings, the FDA warned doctors and patients of the risk and announced that it would require the drug’s manufacturer to conduct further study of the problem.

This latest revelation about Chantix demonstrates yet again that neither drug makers nor the FDA are infallible in protecting patients from  dangerous medications—especially when the FDA lets some drugs and medical products skip a full review.

Have you been harmed by Chantix or another drug? Contact Hodes Milman for a free case evaluation. We’re aggressive personal injury and medical malpractice lawyers based in Orange County, serving all of California. We have the experience to take on the medical industry and have achieved multi-million dollar verdicts for our clients.

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