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May 21, 2008 6:56 pm US/Central
FAA Bans Chantix Use By Pilots, Controllers
WASHINGTON (CBS 11 NEWS / AP) ―
The Federal Aviation Administration is banning the use of the prescription anti-smoking drug Chantix by pilots and air traffic controllers.
The drug has come under fire for reports of serious side effects, and CBS 11 News has been investigating it for months. The FAA says it is concerned about the potential for lapses in alertness and motor control that could lead to serious injury.
The FAA tells CBS 11 News the ban is effective immediately.
The FAA is telling 150 pilots and 30 air traffic controllers to stop working for the next 72 hours if they are taking the drug. The agency calls it "a potential aviation safety issue."
The decision follows a briefing on the side effects by the Institute for Safe Medication Practices. To see the Institute's new study that led to the FAA's move, click the link to the right of this text.
Late Wednesday afternoon Pfizer, the maker of Chantix, issued the following statement to CBS 11 News:
Pfizer Statement
Pfizer is committed to patient safety. We closely monitor post marketing reports of adverse events that we receive for our medicines as part of our commitment to accurately reflect each product's efficacy and safety profile in labeling. Pfizer reports all such events to the FDA and other regulatory agencies and communicates safety information to physicians and patients in a variety of ways including through labeling and educational materials.
Based on Pfizer and the FDA's continuous review of all available safety information, including adverse event reports received to date, the current CHANTIX label accurately reflects the product's efficacy and safety profile. For example, the current label includes safety information pertaining to certain serious neuropsychiatric symptoms, as well as driving and operating machinery.
We understand that the Institute for Safe Medication Practices report was based solely on a review of post-marketing adverse event reporting data. It is important to understand the limitations of spontaneous adverse event reporting. Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality.
As a company, we at Pfizer are committed to helping reduce the prevalence of smoking globally. As part of that mission, we are focused on increasing peoples' understanding of the dangers of smoking and the benefits of quitting.
There are few things that provide greater health benefits than quitting smoking. All medications have both benefits and risks. When considering the use of CHANTIX for their patients, healthcare providers should discuss the risks of smoking, the health benefits of quitting smoking and the product's efficacy and safety profile.
Wednesday afternoon Susan Cruzan, a spokesperson for the U.S. Food and Drug Administration, said officials there had seen the FAA report.
Cruzan advised that the, "FDA is continuing to assess this drug very carefully as part of the continuum of monitoring safety throughout the drug's lifecycle. We agree that these findings are a signal that require further investigation and confirmation."
(© 2010 CBS Broadcasting Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.)
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