U.S. Food and
Drug Administration
FDA Consumer magazine
January-February 2002
Table
of Contents
Accutane Risk Management
Program Strengthened
The Food and Drug Administration has announced changes that strengthen a risk management program regarding pregnancy and a drug used to treat severe acne. Accutane (isotretinoin) is a drug approved to treat the most serious form of acne--a type that is painful, permanently disfiguring, and does not respond to other acne treatments. Accutane is very effective, but its use carries significant potential risks, including birth defects and even fetal death.
The new risk management program is called S.M.A.R.T., the System to Manage Accutane-Related Teratogenicity. "Teratogen" refers to any substance with the potential to cause birth defects. S.M.A.R.T. was developed in consultation with the FDA by Accutane's manufacturer, Roche Laboratories of Nutley, N.J. The program is designed to enhance safe and appropriate use of the drug by strengthening an existing patient education program known as the Accutane Pregnancy Prevention Program.
In recent years, as more and more women have been receiving Accutane prescriptions, the risk that pregnant women may be inappropriately using the drug has increased. In September 2000, the FDA held a meeting of its dermatologic and ophthalmic drugs advisory committee to discuss what additional measures might help prevent exposure of unborn babies to Accutane.
The S.M.A.R.T. program was developed to address the two main goals identified at the meeting. The first is that no woman should begin Accutane therapy if she is pregnant; and second, no pregnancies should occur while a woman is taking Accutane.
The risk management components are described fully within the boxed contraindications and warnings (Black Box) and the precautions sections of the Accutane package insert, which provides prescribing information for health-care professionals. The S.M.A.R.T. program requires the following:
- Doctors who prescribe Accutane
must study the S.M.A.R.T. "Guide
to Best Practices" provided by
Roche, and then sign and return
to Roche a "Letter of Understanding"
certifying their knowledge of the
measures to minimize fetal exposures
to Accutane. The manufacturer has
also developed a continuing medical
education (CME) course for Accutane
prescribers that includes specific,
practical information about pregnancy
prevention. The FDA strongly encourages
participation in this half-day
course. Accutane prescribers will
then receive special self-adhesive
Accutane qualification stickers
from Roche. All Accutane prescriptions
should have the special yellow
sticker attached to the prescriber's
regular prescription form. This
sticker will indicate to the pharmacist
that the patient is "qualified"
according to the new package insert.
This means the patient has had
negative pregnancy tests as described
below, as well as education and
counseling about pregnancy prevention.
The pregnancy test will be repeated
every month throughout the Accutane
treatment course, and no prescriptions
should be given for more than a
one-month supply of Accutane at
a time.
- All female patients must have
two negative urine or serum pregnancy
tests before the initial Accutane
prescription is written. And for
each month of therapy, they must
have a negative pregnancy test
result before receiving their next
prescription, regardless of whether
they are sexually active. Patients
who are, or who might become, sexually
active with a male partner must
also select and use two forms of
effective contraception simultaneously
for at least one month before initiation
of Accutane therapy, during therapy,
and for one month following discontinuation
of therapy, according to the program.
They must sign a patient information/consent
form about Accutane and birth defects,
in addition to the consent form
that all patients should receive
about other potentially serious
risks related to Accutane. Finally,
female patients must be given the
opportunity to enroll in the Accutane
survey. This confidential survey
will collect data to help Roche
and the FDA decide if S.M.A.R.T.
is helping to prevent exposure
of unborn babies to Accutane.
- Pharmacists will dispense Accutane
only upon presentation of a prescription
with the special Accutane qualification
sticker. Pharmacists will dispense
a maximum one-month supply of Accutane,
fill prescriptions within seven
days from the date of "qualification"
and provide a medication guide
for patients with each Accutane
prescription. Requests for refills
and phoned-in prescriptions will
not be filled.
Exposure of an unborn baby to
Accutane is a serious adverse event
and should be reported to Roche Medical
Services at 1-800-526-6367 or the
FDA MedWatch program at 1-800-FDA-1088
(1-800-332-1088). MedWatch can also
be accessed via the Internet at www.fda.gov/medwatch/.
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2001-DEC-26.
