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FDA approval doesn’t mean an FAA blessing

FDA approval doesn’t mean an FAA blessing

P&E Medical

If you watch any amount of television, you’d swear there are new prescription medications coming on the market daily—each with its own enticing ad showing happy people walking their dogs, or hugging their grandchildren, or fishing. Perhaps your family physician has suggested one of these new meds.

While the splashy ad campaign for that medication means it has been approved by the U.S. Food and Drug Administration, it doesn’t signify FAA sanction.

“The FAA’s policy is not to arbitrarily make a medication allowable” simply because it has passed the FDA approval process, said Gary Crump, AOPA director of medical certification.

The agency’s Office of Aerospace Medicine at FAA Headquarters in Washington generally waits at least a year after a medication has received FDA approval before evaluating it for airman use. “That’s because the FAA is concerned about possible adverse physiologic and psychoactive side effects that can occur at altitude but wouldn’t necessarily be observed on the ground,” Crump said.

FAR 61.53 prohibits individuals from acting as pilot in command if they know, or have reason to know, of a medical condition that would make them unable to meet the requirements of the medical certificate they carry—or if they are taking medication or receiving other medical treatment for a medical condition that causes them not to meet the requirements of their medical certificate. Additionally, FAR 91.17 prohibits the use of “any drug that affects the person’s faculties in any way contrary to safety.”

The FAA doesn’t publish a comprehensive list of allowed medications, but AOPA maintains a regularly updated database that you can use as a starting point. Each medication is listed by generic and trade name. The database notes its status with the FAA and gives its drug classification; treatment; any conditions on which the FAA allows the use of the drug; and, in many instances, additional information on the associated medical condition for which the medication may be prescribed .

The FAA periodically reviews medications as new data or side effects become known, and based on that information it does change its opinion on meds that previously were permitted. This happened in 2008 with the smoking cessation drug Chantix, after the FDA sent out an alert indicating the drug could have possible severe psychiatric side effects ranging from changes in behavior to suicide. It’s a good idea to periodically review the FAA’s position on any medications you take.

Don’t forget over-the-counter medications. Many—particularly those containing antihistamines to treat coughs, colds, and allergies—cause notable adverse side effects. Read labels; think about whether the medication would affect your ability to think clearly or pilot an airplane. AOPA recommends that to be safe, you should wait at least five “maximal dosing intervals” after you stop taking the medication before you fly again.

If you have any questions on medication use or don’t find your particular medication on AOPA’s database, contact the medical certification experts at AOPA (800-USA-AOPA). They’re available to take your call weekdays from 8:30 a.m. to 6 p.m. Eastern. Enrollment in AOPA’s Pilot Protective Services can provide you with a more detailed review of medical records.

Email [email protected].

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