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Accutane Warnings Not Getting Through to Many Women

Despite warnings that the acne drug Accutane can cause severe birth defects if taken during pregnancy, many women are still not getting the message. Dr. Emily Senay is here with more.

Why is Accutane so dangerous?

Accutane is a highly effective drug for the treatment of severe acne, but it has long been known to cause miscarriage and severe birth defects if taken by a woman who is pregnant. Two new reports by the Centers for Disease Control and Prevention show that despite efforts to counsel and educate users of the drug, over 2,000 pregnancies were exposed to Accutane between 1982 and 2000 and that some women don't understand the symbols designed to warn them about the drug. Obviously we still need to do a lot more to educate people about the dangers of this drug.

Why isn't the message about the dangers of Accutane getting through?

It's not for lack of a concerted effort by the CDC [the Centers for Disease Control and Prevention], the Food and Drug Administration, and the makers of the drug. Since 1988, they have been working together to educate doctors and patients about the consequences of taking Accutane while pregnant. Part of the problem is that not enough doctors are making sure their patients understand the issues, and part of the problem may be that the patients do not follow the directions for using the drug. Most of the pregnancies reported on in the study could have been avoided if the proper guidelines for use were explained, understood, and followed.

What guidelines should women follow before they start taking Accutane?

You should only take the drug if it is prescribed by a doctor. There are some basic recommendations that need to be adhered to religiously to avoid pregnancy and the potential for miscarriage or birth defects.

First, before you start taking the pills, you need to have two--count 'em, two--negative results from a pregnancy test, including one on the second day of the next normal menstrual cycle after the first test. You should also use two--count 'em, two--forms of effective birth control. You should have repeat pregnancy tests every month while taking the drug. And you should register with the survey that monitors the experience of women who take this drug.

The survey is contained in every package of Accutane pills, which also has a variety of instructions and warnings

What makes those warnings hard to understand for some people?

Researchers found that many women didn't interpret a symbol used on the pill dispenser to warn them about taking the drug while pregnant. It's a pregnant woman in a circle with a slash through it, and the study showed that without proper counseling, the symbol was often misinterpreted.

The same study also found that the symbol confused some patients. About a third confused Accutane with birth control.

What's being done to make sure the drug is used properly by women?

The FDA an the makers of the drug are finalizing plans to strengthen the education efforts already underway.
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