May 23 — Less than 48 hours after FAA learned the anti-smoking medicine Chantix might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately.
The agency took this swift action after a medical safety group, the Institute for Safe Medication Practices, released the results of a study this week that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.
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.
Tilton also pointed out that the board considers both a medicine and the underlying diagnosis to be treated as important factors when weighing medications.