Acne drug should have stricter limits, says panel

Main Category: Pregnancy / Obstetrics
Article Date: 28 Feb 2004 - 0:00 PDT

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Pregnant women and their babies should be better protected from the birth defects cause by a power acne drug called Accutane. This is according to an American advisory panel.

They asked for a mandatory, centralized registry for everyone taking the drug (and its genetic rivals). If pharmacists and prescribers registered within the system, Accutane would become one of the most restricted drugs on the market.

Pharmacists and those prescribing the drug would need proof that the woman wishing to take the acne drug was not pregnant.

Despite voluntary safeguards, pregnant women still seem to be slipping through the net and taking the drug.

Roche, Accutane's producer, is cooperating with the implementation of the safeguards. Roche agrees with the recommendations.

When restrictions were loose, 127 pregnancies were reported. After safety measures were strengthened there were 120 pregnancies.

The risks for the undborn child are heart and nervous system defects if the pregnant mother continues taking Accutane.

At the moment, women must have two negative pregnancy tests (to take Accutane). Then they need to have a pregnancy test every month for four to six months. However, this is not always carried out according to plan.

Roche and generic companies proposed the new plan. The panel added a couple of other recommendations as well.

It is clear that Roche and the panel are working together and have the best interests of patients and their babies in mind.