An FAA Policy Update
By Dr. Thomas T. Yasuhara, ALPA Associate Aeromedical Advisor
Air Line Pilot, April 2004, p.14
|Visit www.aviationmedicine.com/meds.htm, the Virtual Flight Surgeons website, for more detailed information about these and other medications.|
Our office is often asked for a copy of the FAA’s "list of approved medications," and the pilot who calls is usually surprised to learn that the FAA does not publish such a list. The FAA’s stated reasons have included the labor-intense nature of maintaining such a document, given the number of different products that are marketed, their various uses, and the new information about them that emerges almost daily. Also, the FAA may approve many medications for some diagnoses, but not for others, with the result that establishing a simple policy that is consistent for a given drug across all its uses is often not possible.
Based on our daily telephone contacts with airline pilots, we find that the medications of greatest interest tend to be those prescribed for common medical conditions and those that the U.S. Food and Drug Administration has recently approved (or recalled). We have produced the following updates on some of the newer medications that the FAA commonly approves for pilots to use while flying (with any applicable prerequisites).
We have also listed some of those newer medications that the FAA normally does not authorize in conjunction with flying, along with some that the FDA has recently recalled. The FAA approval status we provide for each medication or class of drug is based on our ongoing experience with the FAA special issuance (waiver) process and regular contact with the FAA Aeromedical Certification Division’s aerospace medicine physicians.
In reviewing the medications that follow, several general caveats apply. First, the FAA’s primary concern is whether the underlying medical condition being treated is compatible with safe flying. For example, even though the FAA normally approves use of pseudoephedrine (Sudafed) for upper respiratory congestion, the agency would not consider fit to fly a pilot who is using pseudoephedrine to resolve an earblock associated with vertigo.
Further, a pilot should not fly while using a medication that has caused in that pilot an adverse side effect or allergic reaction, even if the drug is listed here as one the FAA normally approves for a pilot to use while flying. As an example, a pilot using Sudafed to help control mild nasal congestion should clearly not continue flying while using it if that pilot develops an adverse reaction such as dizziness, headaches, or irregular heartbeats.
In most cases, a pilot who is using an FAA-approved medication for the first time should undertake a self-observation period ("ground test") to check for adverse or allergic reactions to the medication. A 48-hour ground test usually suffices. In some cases, however, other ground-test durations, or other clinical prerequisites, may apply before a pilot meets all FAA criteria for flying while using a specific medication.
The information contained in this article is not intended in any way to direct or limit your attending physician’s choice of treatment for a given medical condition. Knowing that a medication is FAA-approved may provide options among several equally effective choices, but should never deprive you of the best clinical choice.
We also caution that the accuracy of the following information can be very short-lived, because the FAA can change its policy at any time and without publicly publishing it. As pilots present requests to fly with a new medication or with a new use for an existing product, new FAA policies can emerge with little notice. As a result, the medications discussed here by no means represent an all-inclusive list. Also, our discussion of the most commonly used medications categorized by medical condition appears on the Virtual Flight Surgeons website, www.aviationmedicine.com/meds.htm.
We do not recommend using this article as the sole reference for returning to flying with the use of a given medication. For the latest information, we suggest that you periodically check for policy updates at our website, or call the ALPA Aeromedical Office to discuss your specific situation with one of our aerospace medicine specialists.
"New" medications NOT FAA-approved
Note: The FAA normally does not consider a new class of drugs for use while flying until 1 full year after the FDA has approved it.
Alpha interferon: This medication is used for many purposes, but it has recently been used to treat hepatitis C. Given periodically by injection, it can cause flu-like symptoms, fatigue, and muscle aches. The FAA briefly approved alpha interferon only when used to treat hepatitis C. However, in late September 2001, the FAA reversed its previous approval and specifically excluded all forms of alpha interferon for medical certification. This prohibition is primarily due to concerns about psychological depression associated with using alpha interferon. The PEG-intron form of interferon alpha is not approved. The FAA will also not allow use of the newly FDA-approved combination drug Rebetron, which combines ribaviron and interferon alpha-2b.
Celexa (citalopram): The FAA has not approved for use by pilots this relatively new antidepressant medication, which generally has minimal side effects. The FAA currently has a blanket ban on all antidepressant medications, although the Federal Air Surgeon’s Office is considering changes to this policy. (See the section about antidepressants and psychoactive medications on our website.)
Ditropan XL (extended-release oxybutynin) and Ditropan (oxybutynin): Although these drugs—which relieve bladder spasms, control overactive bladders, and reduce urinary incontinence, frequency, and urgency—were previously acceptable, the FAA reversed its policy on their use in April 2002 over concerns about medication side effects. (See the section on prostate and urinary medications on our website.)
Levitra (vardenafil): The FAA has not approved pilots to use this treatment for erectile dysfunction but is scheduled to review the treatment soon.
Meridia (sibutramine): A weight-reduction drug that works by suppressing appetite, this product was marketed as a replacement for "Fen-Phen," but without its potentially dangerous heart and lung side effects. We do not anticipate that the FAA will approve pilots’ use of it. (See the section on diet aids and weight-reduction medications on our website.)
Sonata (zaleplon): A short-acting sleep medication, Sonata is marketed as causing no persistent drowsiness beyond 4 hours after use. The FAA typically requires a 48-hour "washout" period after an isolated use of Sonata. FAA physicians have previously stated that use of such medications more often than two to three times per month is unauthorized. (See the section on sleep medications on our website.)
Ultram (tramadol): Though not a narcotic chemically, Ultram is a potent pain reliever that comes with warnings that using it can lead to physical and psychological dependence. Its potential side effects include malaise, confusion, and a lowered seizure threshold. (See the section on pain control medications on our website.)
Medications NOT FAA-approved plus recalled by the FDA
Aristocholic acid:Commonly found in Chinese herbal products, this substance was recalled because of its association with kidney cancer.
Baycol (cerivastatin): This substance was recalled Aug. 8, 2001, after manufacturer Bayer AG announced that 31 deaths had been associated with its use, primarily in the high-dosage form or when combined with another cholesterol-lowering medication called gemfibrozil.
Ephedra/ephedrine: The FDA banned the sale of products containing ephedra because of serious adverse effects (primarily cardiovascular) that had been reported, and the FAA prohibits pilots to use it.
Lotronex (alosetron): Designed to treat symptoms of irritable bowel syndrome, Lotronex has been associated with severe adverse gastrointestinal problems; Glaxo-Wellcome voluntarily removed the product from the market.
Phenylpropanolamine (PPA): The FDA issued a voluntary recall to manufacturers of PPA and a consumer health advisory for products containing PPA, after a Yale University study showed an increased risk of hemorrhagic (bleeding) stroke in women and a theoretical risk in men using PPA. PPA was previously used in prescription and over-the-counter (OTC) nasal decongestants and OTC weight-control products.
Propulsid (cisapride): After reports of deaths from cardiac arrhythmias, Propulsid’s manufacturer, Janssen, voluntarily stopped marketing this medication, which was designed to relieve heartburn-type symptoms and to speed emptying of the stomach. The drug is still available in limited investigational protocols.
"New" FAA-authorized medications
Ambien (zolpidem):The following policy statement appeared in the Federal Air Surgeon’s Medical Bulletin, Fall 2003, Vol. 41, No. 3: the FAA Aeromedical Certification Division "has allowed the use of this sedative providing the airman is not taking it more than twice a week. It cannot be used for circadian adjustment. An airman should not operate an aircraft for 24 hours after taking Ambien."
Recurring prescriptions for any sedatives must be reported on your FAA medical applications. Your AME may opt to defer issuance of your certificate unless you can clearly document that you meet the above restrictions for Ambien use. We recommend that you discuss this with your AME before your FAA medical exam, and if the AME is inclined to defer, then you should contact us at the ALPA Aeromedical Office.
Avandia (rosiglitazone): This oral antidiabetic medication is similar to Rezulin, which was withdrawn from the market. The FAA may now authorize use of Avandia once the patient meets specific FAA criteria for flying with diabetes mellitus and the FAA clears the airman’s case records. (See the section on diabetes on our website.)
Beta interferon: This form of interferon (e.g., Avonex) is used to treat some conditions, such as hepatitis C and multiple sclerosis, and the FAA may authorize its use on a case-by-case basis under a special issuance medical certificate.
Botulinum toxin: The FAA has approved pilots’ use of this product in treating painful muscle spasms and for cosmetic treatments, after a 21-day observation period free of side effects. The FAA must clear the case before a pilot may continue to fly while being treated. If used for diagnostic purposes, only a 72-hour wait after injection is required before flying.
Celebrex (celecoxib): This is a member of a category of arthritis medication, COX-2 inhibitors, which have a much less irritating effect on the stomach than many other anti-inflammatory medications. Celebrex does not affect clotting or bleeding. If Celebrex controls a pilot’s inflammatory symptoms without side effects, the pilot may use it while flying—after a 48-hour ground test—without needing FAA review of case records. (See the section on anti-inflammatory/arthritis medications on our website.)
Detrol (tolterodine): The FAA approves, on a case-by-case basis, this bladder antispasmodic—used to control overactive bladders, generally without adverse effects on vision and light sensitivity. The airman must complete 1 month of ground observation without side effects before the FAA will review the case and approve a waiver. (See the section on prostate and urinary medications on our website.)
Enbrel (etanercept): The FAA will consider granting a waiver to a pilot using this category of injectable medication for moderately severe rheumatoid arthritis after a 30-day ground test, if the side effects are minimal and the degree of arthritis does not impair the pilot’s ability to fly safely. (See the section on anti-inflammatory/arthritis medications on our website.)
Imuran (azothioprine): The FAA recently authorized this immunosuppressive medication, traditionally used with transplants and some cancer chemotherapy, for pilots to use when flying while being treated for rheumatoid arthritis, Crohn’s disease, or ulcerative colitis. The FAA requires the patient to complete a 30-day observation period before he or she may apply for a waiver. (See the section on gastrointestinal drugs on our website.)
Lovenox (enoxaprin): An injectable medication used to prevent blood clots in the legs and lungs in a number of clinical settings, Lovenex may help patients with increased risk factors for blood clotting. The FAA may approve its use on an individual basis, depending on the underlying condition and after reviewing the airman’s case records.
Mebic (meloxicam): The FDA approved this oxicam-derivative, nonsteroidal anti-inflammatory drug in April 2000, and the FAA has authorized pilots to use other medications in this class. Pilots may use Mebic while flying, after a 48-hour ground test shows no side effects, as long as the underlying inflammatory condition is controlled. (See the section on anti-inflammatory/arthritis medications on our website.)
Micardis (telmisartin): The FAA allows a pilot to take this angiotensin-II blocker, used to control blood pressure, after the agency or the pilot’s AME reviews a cardiovascular evaluation of the pilot. (See the section on blood pressure on our website.)
Prandin (repaglinide): A pilot may take this medication, which is used to control blood glucose in diabetics who do not require insulin for control, after the pilot meets specific FAA criteria for flying with diabetes mellitus and the FAA clears the pilot’s case records. (See the section on diabetes on our website.)
Protonix (pantoprazole): This is a member of the proton pump inhibitor category of medications that decrease stomach acid. If it successfully controls a pilot’s symptoms of gastroesophageal reflux disease (GERD) without side effects, the pilot may use it while flying after a 48-hour ground test, without needing the FAA to review his or her case records. If Protonix is used to treat ulcers, other specific FAA criteria must be met before the agency will grant the pilot a waiver. (See the section on antacids on our website.)
Relenza (zanamir): This category of medication, used to reduce the duration and intensity of flu symptoms, is effective against influenza A and B, but not the common cold. It must be taken within the first 2 days of symptoms and used for 5 days. An inhaled form is available. A pilot may resume flying if no adverse side effects from the medication occur after at least 48 hours of self-observation and after symptoms of the underlying infection subside. (See the section on antibiotics and antivirals on our website.)
Remicade (infliximab): The FAA requires that a patient take two to three doses (usually given 2-4 weeks apart) before applying for approval of this treatment for rheumatoid arthritis and Crohn’s disease. (See the section on anti-inflammatory/arthritis medications and gastrointestinal drugs on our website.)
Starlix (nateglinide): The FAA may authorize this oral medication for Type II diabetes that does not generally cause hypoglycemia (low blood sugar) side effects, after the patient meets the specific FAA criteria for flying with diabetes mellitus and the FAA has cleared case records. (See the section on diabetes on our website.)
Synvisc (hylan G-F 20): The FAA may authorize a pilot to fly while undergoing this injection treatment for osteoarthritis after a 48-hour post-treatment observation period shows no adverse side effects, and symptoms of the underlying condition are controlled. (See the section on anti-inflammatory/arthritis medications on our website.)
Tamiflu (oseltamivir phosphate): Used to reduce the duration and intensity of flu symptoms, this medication is effective against influenza A and B, but not the common cold. Tamiflu must be taken within the first 2 days of symptoms and be used for 5 days. Pilots may resume flying if no adverse side effects from the medication occur after at least 48 hours of self-observation and after symptoms of the underlying infection subside. (See the section on antibiotics and antivirals on our website.)
Vioxx (roficoxib): This is another member of a class of COX-2 inhibitors for arthritis that are generally much less irritating to the stomach than other anti-inflammatory medications. Vioxx does not affect clotting or bleeding. If Vioxx controls a pilot’s inflammatory symptoms without side effects, the pilot may use it while flying, after a 48-hour ground test and without needing the FAA to review the case records. (See the section on anti-inflammatory/arthritis medications on our website.)
Xenical (orlistat): A pilot who uses this obesity medication that blocks absorption of fat from the intestine, thus reducing absorbed calories, must undergo a 2-week observation period without significant side effects before the FAA will allow that pilot to return to flying while taking the medication. The pilot need not report using Xenical to the FAA until the next scheduled FAA medical exam. Major side effects may include abdominal gas production and greasy, loose stools. These symptoms may be worse at altitude. (See the section on diet aids and weight-reduction medications on our website.)
Zetia (ezetimibe): Ezetimibe is the first medication in a class of cholesterol-lowering drugs that the FDA approved on Oct. 25, 2002. It works by inhibiting cholesterol absorption in the small intestine and lowers the concentration of LDL ("bad") cholesterol and total cholesterol in the blood. Zetia may be prescribed in combination with other cholesterol-lowering medications, such as the statins. The FAA has approved pilots to use ezetimibe, provided they have completed a self-observation ground test with no adverse effects. (See the section on cholesterol-lowering medications.)
Zelnorm (tegaserod): This gastrointestinal medication has FDA approval as a treatment for irritable bowel syndrome in women who have constipation as a primary symptom. The FAA permits a pilot to use Zelnorm while flying, as long as a self-observation ground test shows no adverse side effects and the symptoms are well-controlled.