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Back To Vidyya FDA Considers Additional Restrictions For Accutane Anti-Acne Medication

Drug Is Already Heavily Restricted To Prevent Possible Birth Defects

An extremely popular treatment for severe acne, Accutane, is facing new restrictions to keep pregnant women from ingesting the drug and causing damage to the developing fetus.

Accutane, the second largest seller for drug company Hoffmann-La Roche Inc., has been known to cause birth defects for some time and is already heavily restricted. Women taking the drug must sign a statement saying they will take two forms of birth control while taking the drug.

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. The FDA has announced that there is evidence that a number of pregnancies among Accutane users have occurred since the drug debuted in 1982 despite efforts to prevent them. The actual number of these pregnancies will be announced at a public meeting.

In existing 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. The packaging of the drug is well-labeled in multiple places and a patient must break multiple seals to achieve access to the pills. Each of the seals warns the user that the drug can cause birth defects.

Hofmann-La Roche keeps the prescription policy for the medication under constant review, 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 other 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.

Other warnings for Accutane are warnings about rare cases of depression, psychosis and suicidal thoughts that may be associated with Accutane. Those cautions were added in 1998.

An FDA advisory panel is considering whether to recommend approval for a new once-a-day formula of Accutane. Current dosing is is twice-a-day.

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Editor: Susan K. Boyer, RN
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