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Clearing Medications for Flying

By Michael Berry, M.D. - Federal Air Surgeon
Source - FAA Safety Briefing July/August 2019

medications

One of the most common questions we receive from airmen in the Office of Aerospace Medicine is, “Can I take X medication?” Less frequently we are asked, “How does a medication get cleared for use while flying?” Let’s explore both of these questions.

It’s important to remember that although a medication may be allowed, that does not automatically mean it is safe for you to fly while using it. You must first consider the underlying condition for which the medication is used, as well as your own particular reaction to that medication.

To be cleared, a medication must first be approved by the Food and Drug Administration (FDA). This means the FDA has determined that the benefits of the product outweigh the known risks for the intended use. The FDA does not take into account specific occupational impairments, although they may issue warnings against use of a particular medication in certain conditions, (e.g., when operating dangerous machinery.) The FDA does not evaluate medications for use in the flight environment.

To clear a medication for airman use, we usually require it to be FDA-approved for a full year. Occasionally, side effects or toxicities that were not recognized in the initial studies may be discovered in this post-introduction period.

We do not evaluate a new medication until the FAA receives an application for a medical certificate on which an airman indicates he is stable, free from side effects, and is benefitting from a particular medication that has not been previously cleared. These requests are screened by our Doctor of Pharmacy, who reviews the available information on the medication. The information is then reviewed by a panel of FAA staff physicians on the Pharmacy and Therapeutics Committee for aeromedical suitability. Depending on the medication, we may also request an opinion from a Federal Air Surgeon Clinical Consultant in the relevant specialty. The final clearance decision is made on my behalf by the FAA’s Director of the Medical Specialties Division.

The sheer volume of new medication requests has been staggering, but the addition of our pharmacist and an automated system for medication review have positioned us to better meet the needs of airmen. Medication review is a dynamic process for both the FDA and the FAA. New information that we must address is constantly emerging on both new and old medications. In all of this change, though, our task remains clear: safety is job one.

Learn More:

“Making a List,” FAA Safety Briefing, Jan/Feb 2019 - https://www.faa.gov/news/safety_briefing/2019/media/JanFeb2019.pdf

“From FDA to FAA,” FAA Safety Briefing, Jan/Feb 2013 - https://www.faa.gov/news/safety_briefing/2013/media/JanFeb2013.pdf

Dr. Michael Berry received an M.D. from the University of Texas Southwestern Medical School, and an M.S. in Preventive Medicine from Ohio State University. He is certified by the American Board of Preventive Medicine in Aerospace Medicine. He served as an FAA Senior Aviation Medical Examiner and Vice-President of Preventive and Aerospace Medicine Consultants for 25 years before joining the FAA. He also served as both a U.S. Air Force and NASA flight surgeon.