FAA Medication Policies

Presented to: Residents Aerospace Medicine

By: Warren S. Silberman, D.O., MPH

Date: March 2008

Federal AviationAdministrationFederal AviationAdministrationThe FAA’s

Management of MedicationsWhat is Acceptable and What is Not ?2008

Presented at: FIDAE

By: Melchor J. Antuñano, M.D., M.S.

Director, Civil Aerospace Medical Institute

Date: 2008

Presented at: FIDAE

By: Melchor J. Antuñano, M.D., M.S.

Director, Civil Aerospace Medical Institute

Date: 2008

FAA Medication Policies 2Federal AviationAdministration2008


CASE SCENARIOS

1. Airman placed on new cholesterol lowering med Zetia (ezetimibe) by treat Doc. AME issues medicalFAA Denies airman


FAA PROCEDURE

• Rule of thumb: The FAA does not grant medical certification for ANY medication in a NEW DRUG CATEGORY until one year has passed from FDA approval


FAA PROCEDURE

• Zetia approved by FDA October 2002– Was approved by FAA November 2003



FAA PROTOCOL

• THINK! It is not usually the medication but the medical condition that is the issue


FAA PROCEDURE

• ANTIHISTAMINES:– Sedating not acceptable: Cetirazine (Zyrtec);

Dipenhydramine (Benadryl);Astelin (Azelastine) Nasal Inhaler

– Allow Allegra (Fexofenadine), Claritin (Loratidine), and Clarinex (Desloratidine)


FAA PROTOCOL

• ANTIHYPERTENSIVE:–Allow ALL except: Reserpine,

Methyldopa, Guanadrel, Guanabenz, & Guanethidine

–And currently Tekturna (Aliskiren)


FAA PROTOCOL

• ASTHMA MEDICATIONS:– ALL acceptable EXCEPT doses of

steroids > 20 mg Prednisone


FAA PROCEDURE

• LIPID LOWERING AGENTS:– ALL medications acceptable – Airman just required to notify FAA at

time of exam


FAA PROTOCOL

• The AME must defer airman who is taking continuous treatment with Anticoagulant, Antiviral, Anxiolytics, Barbiturates, cont’d


Medications

• Chemotherapeutic Agents, Experimental, Hypoglycemic, Investigational, cont’d


Medications

• Mood-ameliorating, Motion Sickness, Narcotic, Sedating Antihistaminic,


Medications

• Sedative, Steroid drugs, or Tranquilizers (Online AME Guide).



FAA PROCEDURE

• Do not grant medical certification while airman actively receiving Radiation therapy or Chemotherapy for cancer treatment


FAA PROCEDURE

• We do not grant medical certification when airman receiving investigational treatment


FAA Procedure

• For Off-Label use of FDA Approved medication is acceptable providing:– The underlying medical condition is not itself

disqualifying and– The medication itself is already acceptable to FAA


Non-approved FDA Use

• Recent decision to accept non FDA approved use of medications if no safety of flight issue

• Example is use of Metformin (oral hypoglycemic) in Dysmetabolic Syndrome or Insulin Resistance – Airman will still be required to provide follow up

material like diabetes on oral agent


FAA PROTOCOL

• The use of Antiepileptic medications for ANY condition is UNACCEPTABLE–For Ex: Gabapentin (Neurontin) for

peripheral neuropathy


FAA PROTOCOL

• GASTOINTESTINAL Drugs:– Unacceptable: Diphenoxylate (Lomotil),

Anticholinergics (Bentyl), Levsin (L-hyoscyamine), Librax (chlordiazepoxide and clidinium), Opiates (Paregoric)

– Acceptable: Limited use of Loperamide (Imodium)


FAA PROTOCOL

• Tricyclic Antidepressants for ANY medical condition –UNACCEPTABLE

• Selective Serotonin Reuptake Inhibitors (SSRIs) for ANY medical condition - NO



DIABETES ON ORAL MEDICATIONS

• Byetta (Exenatide):– Used with Metformin or Sulfonylurea – Must observe for 2 wks. if used with Sulfonylurea– Airman cannot fly for 2 hours after injection

• Januvia (Sitagliptin): – Can only be used with Metformin or

thiazolidinedione – Can be used with both above medications– If used alone a 14 day observation period


DIABETES MELLITUS ON ORAL MEDICATIONS

• (Continued)• Januvia:

– When used with the other acceptable medications must wait 60 days if just beginning and if already was taking the other medications then only 14 day wait

– Acceptable with beta-blocker use



Policy for Airmen

• An airman who has donated 200 cc. or greater blood for plasmapheresis or blood should not fly for 24 hours


CASE SCENARIO

• 41 y/o First-class airman with Colitis has exacerbation and is placed on High-Dose Steroids– What would you do?


CASE SCENARIO

• 50 y/o Third-class airman takes his son’s Methylphenidate, (Ritalin) feels he has ADHD– Thinks the Ritalin makes him more

alert


CASE SCENARIO

• 35 y/o female airman given Celexa (citalopram) for Depression. Since it is a new SSRI, AME issues– Was the AME correct?


CASE SCENARIO

• 50 y/o 1st Cl. Airman develops Type II Diabetes Mellitus and is treated with Glyburide (sulfonylurea). He also happens to be on Atenolol for HTN– The AME issues. . .


CASE SCENARIO

• 45 y/o airman is given Bupropion HCL (Zyban) for a trial of Smoking Cessation. The AME Issues. . .–What’s wrong with this?NOTE: Chantix just accepted


CASE SCENARIO

• 71 y/o airman elects to receive External Beam Radiation and insertion of radioactive seeds (Brachytherapy) for Prostate cancer–He requests a 2nd Cl. Medical



Herbal (or Alternative) Medications

• In general, the FAA accepts the use of these medications

• Do not accept those containing Ephedrine due to cardiac toxicity

• Remember: It is the medical condition, not the medication that is the concern!


Diet Pills

• The ONLY medication approved is Xenical– Xenical (Orlistat) can cause diarrhea and thus a 30

day period of non-flying is required.– We are likely to accept the use of oral hypoglycemic

agent Metformin for treatment of weight loss• The requirements will be just as with Metabolic Syndrome


Websites with Aeromedical Information

• AOPA.org• EAA.org• leftseat.com• www.aviationmedicine.com• www.faa.gov



Part 61.53

• Prohibition on operations during a medical deficiency

• (a) . . . A person who holds a current medical certificate issued under part 67 of this chapter shall not act as pilot in command, or in any other capacity as a required pilot flight crewmember, while that person:


Part 61.53

– (1) Knows or has reason to know of any medical condition that would make the person unable to meet the requirements for the medical certificate necessary for the pilot operation; or


Part 61.53– (2) is taking medication or receiving other

treatment for a medical condition that results in the person being unable to meet the requirements necessary for the pilot operation.


Documents

FAA Medication Policies