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The FAAs Management of Medications

What is Acceptable and What is Not ? 2008


Presented at: FIDAE Presented at: FIDAE Presented to: Residents Aerospace Medicine By: M.D., M.S. By: Melchor J. Antuano, M.D., M.S. By:Melchor Warren J. S.Antuano, Silberman, D.O., MPH Director, Aerospace Director, Civil Aerospace Medical Medical Institute Institute Date: MarchCivil 2008 Date: Date: 2008 2008

Federal Aviation Administration

FAA Medication Policies 2008

Federal Aviation Administration

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

FAA Medication Policies 2008

Federal Aviation Administration

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 Medication Policies 2008

Federal Aviation Administration

FAA PROCEDURE
Zetia approved by FDA October 2002
Was approved by FAA November 2003

FAA Medication Policies 2008

Federal Aviation Administration

FAA Medication Policies 2008

Federal Aviation Administration

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

FAA Medication Policies 2008

Federal Aviation Administration

FAA PROCEDURE
ANTIHISTAMINES:
Sedating not acceptable: Cetirazine (Zyrtec); Dipenhydramine (Benadryl);
Astelin (Azelastine) Nasal Inhaler

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

FAA Medication Policies 2008

Federal Aviation Administration

FAA PROTOCOL
ANTIHYPERTENSIVE:

Allow ALL except: Reserpine, Methyldopa, Guanadrel, Guanabenz, & Guanethidine And currently Tekturna (Aliskiren)

FAA Medication Policies 2008

Federal Aviation Administration

FAA PROTOCOL
ASTHMA MEDICATIONS: ALL acceptable EXCEPT doses of steroids > 20 mg Prednisone

FAA Medication Policies 2008

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FAA PROCEDURE
LIPID LOWERING AGENTS:
ALL medications acceptable Airman just required to notify FAA at time of exam

FAA Medication Policies 2008

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FAA PROTOCOL
The AME must defer airman who is taking continuous treatment with Anticoagulant, Antiviral, Anxiolytics, Barbiturates, contd

FAA Medication Policies 2008

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Medications
Chemotherapeutic Agents, Experimental, Hypoglycemic, Investigational, contd

FAA Medication Policies 2008

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

FAA Medication Policies 2008

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

FAA Medication Policies 2008

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FAA Medication Policies 2008

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

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FAA PROCEDURE
We do not grant medical certification when airman receiving investigational treatment

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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

FAA Medication Policies 2008

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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

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FAA PROTOCOL
The use of Antiepileptic medications for ANY condition is UNACCEPTABLE
For Ex: Gabapentin (Neurontin) for peripheral neuropathy

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FAA PROTOCOL
GASTOINTESTINAL Drugs:
Unacceptable: Diphenoxylate (Lomotil), Anticholinergics (Bentyl), Levsin (Lhyoscyamine), Librax (chlordiazepoxide and clidinium), Opiates (Paregoric) Acceptable: Limited use of Loperamide (Imodium)
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FAA PROTOCOL
Tricyclic Antidepressants for ANY medical condition UNACCEPTABLE Selective Serotonin Reuptake Inhibitors (SSRIs) for ANY medical condition - NO
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FAA Medication Policies 2008

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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

FAA Medication Policies 2008

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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

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FAA Medication Policies 2008

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Policy for Airmen


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

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

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CASE SCENARIO
50 y/o Third-class airman takes his sons Methylphenidate, (Ritalin) feels he has ADHD
Thinks the Ritalin makes him more alert

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

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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. . .

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CASE SCENARIO
45 y/o airman is given Bupropion HCL (Zyban) for a trial of Smoking Cessation. The AME Issues. . . Whats wrong with this?

NOTE: Chantix just accepted

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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
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FAA Medication Policies 2008

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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!

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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

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Websites with Aeromedical Information


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

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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:

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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

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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.

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