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Chantix Among Drugs Being Reviewed by FDA

Jun 5, 2009 | Parker Waichman Alonso LLP

The anti-smoking drug Chantix is among 20 medications currently undergoing a  Food & Drug Administration (FDA) safety review.  According to Reuters, Chantix was included on a list of such  drugs released by the FDA yesterday. Other drugs on the list include Provigil, which is used to treat sleep disorders; the weight-loss drug orlistat; and Detrol, a drug used to treat overactive bladder.

The list, which the FDA issues on a quarterly basis, is part of the agency's ongoing effort to inform the public about early investigations of potential side effects that have been reported, Reuters said.

It should be of no surprise to readers of this blog that Chantix made the FDA's list, as its safety problems are well-documented.  In 2008,  Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning - the agency’s highest safety alert.  

The FDA  is now reviewing Chantix for a possible association with accidental injury, vision impairment and other issues.  According to Reuters, the Chantix review was prompted by reports of  accidents, vision loss and other problems in hundreds of patients.

The FDA's latest safety review comes on the heels of a report published last year by the Institute for Safe Medicine Practices, which found that the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of 2008.  According to the report, the only other drug that even came close to matching Chantix during the same period was heparin   which was the subject of a recall  earlier that year. According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

According to Reuters, other drugs on the list include:

• Orlistat (sold as the prescription drug Xenical, and over-the-counter as Alli) for a risk of liver injury;
• Nuvigil and Provigil for serious skin reactions that were identified as an issue with the drugs in 2007;
• Detrol for reports of Stevens-Johnson syndrome, a serious skin reaction;
• HIV drug, Sustiva due to one report of an eye-related birth defect;
• The contraceptive Yasmin, for a possible risk of pancreatitis.