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FDA ANNOUNCES CHANGES TO THE RISK MANAGEMENT PROGRAM TO PREVENT BIRTH DEFECTS CAUSED BY ACCUTANE

Accutane is approved to treat the most serious form of acne. This form of acne 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.

In recent years, as more women have been receiving prescriptions for Accutane, the risk that pregnant women may be inappropriately using the drug has increased. On September 18, 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 this meeting:

1) no woman should begin Accutane therapy if she is pregnant; and 2) no pregnancies should occur while a woman is taking Accutane. S.M.A.R.T. involves Accutane prescribers, patients, and pharmacists in a partnership to prevent fetal exposure. 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 healthcare professionals.

The S.M.A.R.T. program requires the following:

• Prescribers must study the S.M.A.R.T. "Guide to Best Practices"provided by Roche, and then sign and return to Roche the 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 prescribers that includes specific, practical information about pregnancy prevention. FDA strongly encourages participation in this half-day course. Prescribers will then receive from Roche special self-adhesive Accutane Qualification Stickers. All prescriptions for Accutane 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, which means that the female 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 might become, sexually active with a male partner must also select and use two forms of effective contraception simultaneously for at least one month prior to initiation of Accutane therapy, during therapy, and for one month following discontinuation of therapy. 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. Finally, female patients must be given the opportunity to enroll in the Accutane Survey. This confidential Survey will collect data to help Roche and FDA decide if S.M.A.R.T. is helping to prevent exposure of unborn babies to Accutane. Patients who agree to participate in the Survey will be making a major contribution to the public health by helping identify aspects of S.M.A.R.T. that could be improved as experience with it grows.
• 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 (i.e. more Accutane without a new prescription) 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, or directly to the FDA MedWatch Program. The contacts are as follows: Roche Medical Services 1-800-526-6367, FDA MedWatch program 1-800-FDA-1088. MedWatch can also be accessed via the Internet at www.fda.gov/medwatch/index.html.

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