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Editor: Renee Preston
Profession: Attorney at Law

Category: Accutane News

Young women aren't getting the warning that they should not take the Accutane and its generic versions during pregnancy.

Accutane is not intended for use during pregnancy due to the risk of birth defects.

That risk is stressed in information from the drug's makers. The FDA also recently tightened its rules to try to prevent pregnant women from taking acne drugs such as Accutane or its generic versions.

The drug's old pregnancy prevention program was voluntary. It wasn't always heeded, a new report shows.

The report included 34 women who had taken Accutane or its generic versions while pregnant. Between April 2002 and September 2004, the women had voluntarily called a hotline run by the Organization of Teratology Information Services.

A teratogen is a substance that causes birth defects.

Many of the women said they didn't remember hearing or following the old guidelines.

For instance, the old program recommended that women get birth control counseling and two negative pregnancy tests before starting the drug.

Eight women said they didn't remember being counseled about birth control, and 25 said they hadn't gotten a second pregnancy test before taking acne drugs.

Also, the program advised monthly pregnancy tests while women took the Accutane or similar acne drug. More than half said they hadn't done that.

Acne drugs are usually taken for four to six months.

In addition, few women reported having the type of severe acne for which the drug is intended.

The new program, announced by the FDA, is called "iPLEDGE." The iPLEDGE plan requires virtually everyone involved with prescribing, supplying, or using acne drug Accutane or its generic versions to register and accept certain responsibilities such as getting two negative pregnancy tests within seven days of starting Accutane and agreeing to use two forms of birth control.