Anti-Smoking Medication Grounded. Chantix® Disallowed for Pilots, Controllers!
The anti-smoking drug Chantix from Pfizer, Inc., has been steeped in controversy since it came on the market in 2006. It has been the subject of U.S. Food and Drug Administration advisories due to reports of Chantix-induced dreams, attempted suicides and at least one death. Now the Federal Aviation Administration (FAA) has ordered any pilots and air traffic controllers using Chantix to stop taking the drug.
The FAA was quick to respond to a report provided by a medical safety group that found evidence for health reactions that could prove detrimental to pilots. The Institute for Safe Medication Practices studied Chantix and found that users could suffer seizures, loss of consciousness, heart attacks, vision problems and a variety of psychiatric instabilities. Approximately 150 pilots and 30 controllers are known to use the medication. (The Institute for Safe Medication Practices is the nation’s only nonprofit organization devoted entirely to medication error prevention and safe medication use.)
When a new drug comes on the market, the FAA is slow to approve it for use by pilots. After the FDA gives its approval for a medication to be used by the general public, the FAA requires a waiting period of one year to assess its safety for people who are trusted with airplanes. So when Chantix was approved by the FDA in 2006, it wasn’t allowed for pilots and controllers until July of 2007.
By November of 2007, the FDA was beginning to get reports that there might be a problem with Chantix. At the same time, the FAA’s Federal Air Surgeon Dr. Fred Tilton was becoming aware of anecdotal information circulating about the drug. “There were indications, but no clear data,” he said. “We don’t just act indiscriminately.”
However, when more conclusive data began to surface, Dr. Tilton’s Office of Aerospace Medicine was quick to move forward with the ban. To make certain the word got out, the FAA sent a notice to all registered pilots and air controllers. Aviation medication examiners across the United States, major pilot associations and the air traffic controllers union were all quickly notified. It is very evident that the Federal Air Surgeon and his team took the threat of Chantix-caused health problems very seriously.
Following on the heels of the FAA, the Federal Motor Carrier Safety Administration has issued a statement prohibiting the certification of commercial vehicle operators (truck and bus drivers) who use Chantix. Also, 32,000 U.S. veterans, some of whom participated in Chantix safety studies, will be receiving a warning letter that alerts them to the possibilities of adverse Chantix reactions.
Currently, approximately 6.5 million people in the United States take Chantix. The product was recently approved for sale in the United Kingdom as well. Chantix is purported to help smokers quit the habit by easing withdrawal symptoms and also blocking the desire to take up the habit in the future. The drug has become a top seller for Pfizer, Inc. but the issuing of new prescriptions have fallen off markedly following these announcements.