FDA limits prescriptions for acne drug accutane AP - 10/31/01

- It will be tougher next year for women to get a prescription for the acne drug Accutane, under a new program announced Wednesday by the Food and Drug Administration. Accutane, used to treat the most serious form of acne, can have dangerous side effects for pregnant women, including fetal death.

For years health authorities have worked to advise women not to use the drug when they are pregnant. Despite that effort, the FDA said that between 1982 and June 30 of this year there have been 2,181 reports of women on Accutane becoming pregnant. Those have included 1,310 elective abortions, 242 spontaneous abortions, 192 normal babies born and 166 reports of babies born with congenital abnormalities.

The effort to prevent these pregnancies will be scaled up starting in January, with a special label for prescriptions. Pharmacists will be advised not to fill Accutane prescriptions that lack the new label. When a doctor places the new label on a prescription he is certifying that the patient has had a negative pregnancy test, understands the danger and is committed to using contraception, said Dr. Jonathan Wilkin of the FDA.

The woman will have to sign a consent form saying she understands the danger and what she needs to do. Wilkin said the idea is to create a three-way partnership among doctor, patient and pharmacist to prevent fetal injury or death from this drug. The FDA said the maker of Accutane, Roche Laboratories, has prepared education material for doctors and patients and will offer physicians a half-day refresher course dealing with the medication. The company will provide the special stickers to doctors who take the course or who assure the company they have sufficient training to properly dispense the medication.

Under the new program:
a) The new yellow sticker should be attached to the prescriber's regular prescription form to indicate the patient has been counseled and signed a consent form to receive the medicine. All female patients must have two negative pregnancy tests as well as education about pregnancy before their first Accutane prescription.
b) No Accutane prescriptions will be given for more than one month supply at a time and the patient must have a new negative pregnancy test before each renewal.
c) Female patients who are, or might become, sexually active with a male partner must use two forms of effective contraception simultaneously for at least one month prior to starting Accutane, during therapy, and for one month following discontinuation of the drug. d) Pharmacists will dispense Accutane only on receiving a prescription with the special Accutane sticker. Requests for refills without a new prescription and phoned-in prescriptions will not be filled.