FAA bans the anti-smoking drug Chantix

The Federal Aviation Administration (FAA) has banned pilots and air traffic controllers from using the prescription anti-smoking drug CHANTIX® (varenicline), manufactured by Pfizer, after new information became available about possible side effects that could impact aviation safety. The action was taken after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use the drug.

An announcement about the FAA ban on Chantix explained:

Approximately 150 pilots and 30 controllers are known to use the medication, although the exact number isn't known. To make sure all pilots and controllers got the word, FAA sent a notice to all registered pilots and controllers. It also alerted all aviation medication examiners across the country and notified major pilot associations and the air traffic controllers union, NATCA. An estimated 6.5 million people worldwide have used Chantix.

The Food and Drug Administration (FDA) approved the Pfizer-made drug for sale in 2006, and the FAA first approved Chantix for pilot and controller use in July 2007. Employees who reached the maximum dose at that time were required to wait 72 hours before working, and had to have a letter from their physician.

In November 2007, the FDA began to receive reports of psychiatric problems associated with the medication. The FAA’s Federal Air Surgeon Fred Tilton said he was aware of the anecdotal information circulating about Chantix, but chose to rely on hard data as it became available. “There were indications, but no clear data,” he said. “We don't just act indiscriminately.”

When more conclusive data was published this week, Tilton's Office of Aerospace Medicine moved quickly in response.

Medications approved for pilot and controller use must undergo a rigorous review process before being considered acceptable. When a new class of drug comes on the market, members of FAA’s Office of Aerospace Medicine require at least a year for data to emerge regarding its effects, at which point a review board can then be convened. If any red flags are detected by the board during evaluation, the medication will be prohibited.

Nicotine replacement products such as the nicotine patch, gum and lozenges are still allowed.

If you are interested in having a look at the report that prompted the FAA to ban Chantix, here is the link to the full document:

Strong Safety Signal Seen for New Varenicline Risks - The Institute for Safe Medication Practices, May, 2008