U.S. weighing new limits on acne drug Accutane

WASHINGTON (Reuters) -- The prescription drug Accutane, a popular treatment for severe acne, could face new restrictions to keep pregnant women from taking it and risking serious birth defects.

Accutane, made by Roche Holding unit Hoffmann-La Roche Inc., is known to cause birth defects, and the drug already comes with strict limits that aim to make sure women taking it do not conceive.

At a public meeting Monday and Tuesday, a panel of outside advisers to the Food and Drug Administration (FDA) is set to debate whether new measures are needed to prevent pregnancies.

An FDA official said the agency has evidence that pregnancies among Accutane users have occurred since the drug debuted in 1982 despite efforts to prevent them. Numbers of known pregnancies will be made public at the meeting, the official said.

Among the restrictions, doctors must give women written and verbal warnings about Accutane's potential to cause birth defects. Women also must sign consent forms promising to use two types of birth control simultaneously to prevent pregnancy.

"We always have had the pregnancy prevention program under revision," Hoffmann-La Roche spokeswoman Melissa Ziriakus said.

In February, the company began sending pregnancy tests to doctors who prescribe Accutane. Women take the first in the doctor's office and the second at home before they start taking the drug.

Few drugs have such restrictions. One is thalidomide, the drug used for morning sickness before it was linked to birth defects in the 1950s and 1960s. Thalidomide now is approved to treat leprosy and is under study for fighting other diseases.

Accutane is the second-biggest seller for Roche. Mark Ravera, a drug industry analyst for Mehta Partners, said he did not expect any new limits to adversely affect Accutane sales.

"There are so many controls on it already because of the pregnancy risk that it doesn't seem this is going to be a major deal," Ravera said.

The FDA also is asking the advisory panel for input on the usefulness of warnings about rare cases of depression, psychosis and suicidal thoughts that may be associated with Accutane. Those cautions were added in 1998.

Also, the panel is being asked whether to recommend approval for a new once-a-day formula of Accutane. Dosing for the current version is twice a day.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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