aviationmedicine Antidepressants in Aviation Australian researchers found that pilots who took prescribed antidepressants were no more likely than others to be involved in accidents and incidents.
use of antidepressant medications by crew or air traffic controllers while using antide-
pilots and air traffic controllers does not
pressants, provided specific criteria are met and
maintained,” the report on the study said.
The criteria include having the pilot or
10 years of aviation safety data from Australia,
controller interrupt flight or control duties while
where aeromedical authorities have allowed the
being introduced to the antidepressant medica-
supervised use of antidepressants since 1987.
tion and ensuring that the pilot or controller
The study, published in Aviation, Space,
experiences only minimal side effects that do
and Environmental Medicine, the journal of
not interfere with flight or control duties, the
the Aerospace Medical Association (AsMA),
reviewed the cases of 962 pilots and controllers,
The Civil Aviation Safety Authority of Aus-
half of whom were treated with prescribed an-
tralia (CASA) includes these criteria in assessing
tidepressants and half of whom were not. There
pilots and controllers — including those who
was no statistical difference between the number participated in the study — along with other of accidents and incidents involving members of criteria requiring them to be under the care of the two groups.1
a medical practitioner with experience treat-
“This study found no evidence of adverse
ing depression; to be “stable on an established
safety outcomes arising from permitting indi-
and appropriate dose of medication for at least
viduals to operate as commercial or private air
four weeks” before resuming flight or control
flight safety foundation | AeroSAfetyWorld | february 2008
aviationmedicine
duties; and to have minimal side effects, no drug
The Australian study included pilots and
interactions and no allergies to the antidepres-
controllers taking all types of antidepressants
and found no difference in accident or incident
history based on the type of antidepressant.
taking antidepressants to undergo a clinical
Data indicated that a slightly higher num-
review at least once a month and to submit a
ber of accidents and incidents occurred among
progress report to CASA every six months for
pilots and controllers immediately before the
at least the first year of treatment. In addition,
start of antidepressant medication. Although
CASA requires an absence of other significant
the increase was considered statistical y insig-
psychiatric problems and no use of other psy-
nificant, the report said that “the data raise the
choactive medications, along with control of all possibility that the earlier use of antidepressants symptoms of depression; an absence of suicidal
might actual y improve safety in a group who
Antidepressants in Aviation
thoughts and “features of arousal,” such as ir-
subsequently go on to use them. If so, early
ritability or rage; and the presence of a normal
identification and treatment of this group may
improve aviation safety while allowing contin-
CASA’s decision to allow pilots and control-
lers taking antidepressants to participate in
The report added, “If there is an excess of
aviation operations came soon after the intro-
accidents in aircrew who would benefit from
duction of a class of antidepressants called selec-
antidepressants but were not [using] them at
tive serotonin reuptake inhibitors (SSRIs), which the time of the accident, this might provide an had fewer and milder side effects than older
argument for wider use of antidepressants than
antidepressant medications such as monoamine
is currently the case in Australia, and has pro-
oxidase inhibitors (MAOIs) and tricyclics.2
found implications in those jurisdictions where
The side effects associated with SSRIs and
antidepressant use is prohibited [by] certificate
a related class of antidepressants known as
serotonin-norepinephrine reuptake inhibitors (SNRIs) — most common during the first days
Common Condition
or weeks of use — are individualized, but they
Depression within the general population is
include decreased appetite, nausea, diarrhea,
relatively common. The United Nations World
nervousness, insomnia, headache and sexual
Health Organization (WHO) estimates that
dysfunction. Tricyclics may have side effects
it affects 121 million people worldwide; other
that include sedation, decreased blood pres-
estimates have been considerably higher.5 Symp-
sure, increased heart rate, dry mouth, blurred
toms include a depressed mood, loss of interest
vision, constipation, difficulty urinating
or pleasure, feelings of guilt or low self-worth,
and confusion. MAOIs — which usual y are
disturbed sleep, poor appetite, lack of energy
prescribed in cases in which other classes of
and poor concentration — problems that WHO
antidepressants have not helped — can cause
says can lead to “substantial impairments in
a dramatic increase in blood pressure if they
an individual’s ability to take care of his or her
are taken in combination with cold and cough
everyday responsibilities.” Depression also can
remedies that contain phenylpropanolamine
lead to suicide, which claims about 850,000 lives
CASA guidelines today specify that the au-
thority may “on a case-by-case basis” certificate
people with depression can be effectively treated
applicants who are prescribed (and are taking)
with antidepressant medications and “brief,
SSRIs sertraline (brand name Zoloft) and cit-
alopram (brand name Celexa), and venlafaxine
The Australian study estimated that about
(brand name Effexor) — a type of SNRI.4
4.5 percent of the adult population uses
WWW.flightsafety.org | AeroSAfetyWorld | february 2008
aviationmedicine
antidepressant medications, but only about 1
medication has been “well established and the
percent of “aviation certificate holders” could
depression has been ful y treated,” Evans said.
be identified as having taken antidepressants
If the proposal is adopted, considerable time
while certificated. The study said that the lower may be required to establish procedures for
“There is a groundswell
rate among pilots and air traffic control ers
“may reflect under-reporting of antidepressant
“It is considered that it is safer to know that
use rather than different levels of medication
pilots are being treated for depression and being
of opinion that supports
among pilots and air traffic controllers.”
monitored rather than have pilots fly whilst de-
CASA’s requirements differ from those of
pressed (not on medication) or fly whilst taking
the carefully controlled
most other civil aviation authorities, including
undisclosed treatment,” Evans said.
those in the United States and Europe, which do
use of antidepressants.”
not currently allow aeromedical certification of
Canadian Study
Civil aviation authorities in a few countries
In the United States, the Federal Aviation
in addition to Australia already have taken
Administration (FAA) policy is that “the medi-
steps to allow some pilots to fly while taking
cal condition of depression is disqualifying, as
well as every medication that is used for the
In Canada, for example, a long-term study
condition,” Dr. Warren S. Silberman, manager
is being conducted involving several pilots tak-
of the FAA Civil Aerospace Medical Institute
ing specific types of antidepressants to evaluate
Aerospace Medical Certification Division, wrote their performance while using the medications, in a 2005 Federal Air Surgeon’s Medical Bul etin.6
and authorities are continuing to review related
He added, however, that an FAA panel has been
medical literature, a Transport Canada (TC)
studying “the feasibility of granting medical cer-
spokeswoman said. Each of the pilots is permit-
tification to individuals that have been stable on
ted to fly only as part of a two-member crew.
SSRIs for the treatment of depression,” provided
The study began in the mid-1990s, and in
the depression has not been accompanied by
2001, Dr. Hugh O’Neil , then the TC director of
civil aviation medicine, said that TC was “pro-
The FAA allows pilots who have been treated ceeding very, very cautiously” with the study
with antidepressants to receive medical certifi-
while “looking for some consensus of opinion
cation if they have had no significant symptoms
of depression for at least 90 days after stopping
TC’s Handbook for Civil Aviation Medical
the medication. They also must be evaluated by
Examiners describes requirements similar to
a psychiatrist and a psychologist before issuance
those outlined by CASA: Applicants for aero-
of a medical certificate, and reports must be
medical certification “who have been treated
for a depressive illness and who are on main-
In Europe, the Joint Aviation Authorities
tenance or prophylactic therapy with … SSRIs
medical committee has agreed to a proposal
may be considered for medical certification on
that — if it receives final approval — eventu-
an individual basis after review by the CAM [the
al y would allow commercial pilots taking “a
TC Civil Aviation Medicine Division] Aviation
few specific antidepressants” to continue flying,
said Dr. Sal y Evans, chief medical officer of the U.K. Civil Aviation Authority and head of the
Changing Opinions
European Aviation Safety Agency Flight Crew
Worldwide, the opinions of some aeromedical
Licensing Medical Core Group. The proposal
would limit acceptable medications to a few
“There is a groundswell of opinion that sup-
SSRIs, require close monitoring of the pilots
ports the careful y controlled use of antidepres-
and allow medical certification only after the
sants, this being better than having a policy that
flight safety foundation | AeroSAfetyWorld | february 2008
aviationmedicine
grounds pilots when they take any antidepres-
groups to manage depressed aviators who require
sant medication,” said Dr. Anthony Evans, chief
SSRI antidepressants. Protocols designed to ag-
of the Aviation Medicine Section at the Interna-
gressively manage the ful spectrum of adverse
tional Civil Aviation Organization (ICAO) and
possibilities related to SSRI use may enable the
no relation to the U.K. CAA’s Dr. Sal y Evans.
safe use of SSRIs in formerly depressed aviators
“The latter policy results in pilots flying when
who suffer no aeromedical y significant side ef-
depressed and untreated, or failing to declare
fects. In these closely managed cases of depressive
their depression/treatment to an AME [aviation
disorders, special issuances or waivers for SSRI
medical examiner] and potential y taking anti-
depressants that have unacceptable side effects from the flying viewpoint.”
Despite the increasing tendency of special-
1. Ross, James; Griffiths, Kathleen; Dear, Keith;
ists to believe that some use of antidepressant
Emonson, David; Lambeth, Len. “Antidepressant Use
medications by pilots would be acceptable,
and Safety in Civil Aviation: A Case-Control Study
debate continues about precisely what medica-
of 10 Years of Australian Data.” Aviation, Space, and
tions are acceptable and what problems should
Environmental Medicine Volume 78 (August 2007):
be treated by these medications, which some-
times are administered for conditions other
2. MAOIs include phenelzine (brand name Nardil)
than depression; how long pilots might be
and tranylcypromine (brand name Parnate).
required to stop flying before and after they be-
Tricyclics include amitriptyline (brand name Elavil), desipramine (brand name Norpramin),
gin using the medications; and how these cases
imipramine (brand name Tofranil) and nortrip-
should be monitored. “In other words,” Evans
said, “the logistics of introducing such medica-tion into the aviation system without compro-
mising safety is not yet ful y harmonized.”
ICAO has begun changing its standards and
recommended practices to enable the use of an-
ICAO has begun changing
tidepressants by pilots and air traffic controllers
if the national licensing authority determines
5. United Nations World Health Organization.
that the medications present no significant risk
Depression. <www.who.int/mental_health/manage-
its standards and
In a 2006 preliminary, unedited version of
6. Silberman, Warren S. “Certification Update: SSRI
recommended practices
its Manual of Civil Aviation Medicine, ICAO
Policy Reminder.” Federal Air Surgeon’s Medical
said, “In recent years, the use of SSRI … has
Bulletin Volume 43 (2005–2). to enable the use of
become widespread, and there is indication
that such treatment, aimed at preventing a new
8. Transport Canada. Handbook for Civil Aviation
depressive episode, may be compatible with
antidepressants.
flying duties in careful y selected and moni-tored cases.”9
9. The 1985 version of the manualhad said that pilots
AsMA has called for an end to “current
typical y should not fly while taking antidepressant medication and “ordinarily … should not be allowed
absolute prohibitions against pilots flying while
to return to flying unless they have been off medica-
taking SSRIs and adoption of aeromedical pro-
tocols that include careful y controlled follow-up and review.”10
10. Jones, D.R.; Ireland, R.R. “Aeromedical Regulation
of Aviators Using Selective Serotonin Reuptake
In 2004, AsMA recommended that “all certifi-
Inhibitors for Depressive Disorders.” Aviation, Space,
catory and regulatory authorities … consider
and Environmental Medicine Volume 75 (May 2004):
immediately instituting a policy of using study
WWW.flightsafety.org | AeroSAfetyWorld | february 2008
EryDel announces US IND approval for EryDex Urbino, Italy – April 29 - EryDel SpA (www.erydel.com), a Drug Delivery Company specialized in the development of drugs and diagnostics delivered through red blood cells (RBCs), announced today that it has received approval to start its first study in the US. The Investigational New Drug (IND) Application for EryDex (Dexamethasone Sodium Phosphate