Generic Version of Acne Drug to Be Sold, With Precautions

By THE ASSOCIATED PRESS

ASHINGTON, Nov. 9 — People with severe acne will soon be permitted to buy a generic version of the drug Accutane if they follow strict rules intended to keep it from pregnant women.

Health officials have worked for years to associate the name Accutane with birth defects so women with any prospect of pregnancy will know to avoid it. A generic version of the drug, which the Food and Drug Administration approved on Friday, will be sold under its chemical name, isotretinoin. The question now is whether doctors and women will connect the name to Accutane.

"One of our biggest concerns was that because they'll have different names, that may lead to confusion," said Dr. Sandra Kweder of the Food and Drug Administration.

The generic version of Accutane will be made by Genpharm, a Toronto unit of Merck of Germany.

The drug is not for treating routine pimples, but for the most severe form of acne. Its side effects include serious birth defects and fetal death. A link to depression and suicide is also possible, but unproved.

Despite intense efforts to keep the drug from pregnant women, the Food and Drug Administration has in the last decade had more than 2,000 reports of women becoming pregnant while taking Accutane. The vast majority chose abortion, but some had miscarriages or had babies with birth defects. Others had normal babies.

Last spring, the drug agency and Roche Laboratories, the maker of Accutane, began a program to make it harder for women to get the drug. Among other things, prescriptions require a doctor's certification that the women have tested negative for pregnancy and have agreed to use birth control. Pharmacies are not permitted to fill Accutane prescriptions without the certification, and they may dispense only a month's supply. The women must have new pregnancy tests before prescriptions can be renewed.

Genpharm must follow the same safety steps, the government said.

The company did not return a call seeking information about how much its generic version would cost or when sales would begin. Generics typically cost half as much as brand-name drugs. Accutane typically sells for $4 a pill.