FDA Taking Another Look at Chantix
May 30, 2008 | Parker Waichman Alonso LLP The release of a Chantix study last week that linked the drug to numerous side effects has prompted the Food & Drug Administration (FDA) to initiate another safety review of the drug. The review will mark the second such investigation for Chantix, which is already being scrutinized because of its association with psychiatric side effects, including suicide and depression.Chantix is a popular anti-smoking drug made by Pfizer, Inc. It was approved in 2006, and was the first nicotine receptor partial agonist - meaning it blocks nicotine receptors in the brain - on the market. Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers. Earlier this week, the Federal Motor Carrier Safety Administration said that "… it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.”
According to Reuters, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency is reviewing all the reported cases. "We're are looking at them, but it takes awhile," she said in an interview. Woodcock said the agency does not yet know whether the drug directly caused the complications cited in the researchers' report.
No one should expect the FDA to reach a conclusion on Chantix anytime soon, however. Woodcock conceded that the agency simply does not have the resources available to complete the Chantix probe promptly.
This will be the second time the FDA has taken a look at Chantix. After the drug was linked to 34 suicides in the US, the agency began a safety review. According to an FDA Nov. 2007 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate 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.