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FDA List of Drugs Undergoing Safety Review Includes Chantix

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The Food & Drug Administration (FDA) released a  list of  20 drugs yesterday that are currently undergoing a safety review.  Not surprisingly, the anti-smoking drug Chantix made the list.

According to Reuters, other drugs on the FDA’s 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.

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.

According to Reuters, the FDA is reviewsing 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.

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.

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