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Rules Set on Acne Drug Prescriptions

November 01, 2001|From Associated Press

WASHINGTON — 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 from 1982 to June 30 of this year, there have been 2,181 reports of women on Accutane becoming pregnant.

Among those pregnant women, there have been 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 increase 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, Dr. Jonathan Wilkin of the FDA said.

The woman will have to sign a consent form saying she understands the danger and what she needs to do.

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 that they have sufficient training to properly dispense the medication.

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