Drug Warning For Pregnant Women

FDA Tightens RUles On Accutane Use

(CBS)  Although it's an effective drug for acne, Accutane causes miscarriage and severe birth defects if taken by a woman who is pregnant. And the latest numbers show that Accutane pregnancies are still occurring despite recent efforts to counsel and educate users of the drug.

In a one-year period after safety measures were strengthened in 2002, 120 pregnancies were reported, compared with 127 during the year before when there were looser restrictions.

Now advisers to the Food and Drug Administration want a mandatory registry to track women who take the drug in an effort to make sure they are following the guidelines to prevent pregnancy, The Early Show medical correspondent Dr. Emily Senay reports.

Accutane is widely prescribed because it is a highly effective drug for the treatment of severe acne. It's also increasingly prescribed for less severe cases.

The drug has been called a silver bullet for acne because it tackles acne on several levels to clear it up.

It's usually prescribed for a five-month period and it's effective in about forty percent of cases.

Guidelines for taking Accutane:

There are some basic recommendations that need to be adhered to religiously to avoid pregnancy and the potential for miscarriage and birth defects.

First, before you start taking the pills, you need to have 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 forms of effective birth control. You should have to repeat pregnancy tests every month while taking the drug.

Part of the problem is that not enough doctors make 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.

The new registry would require women to produce a negative pregnancy test before getting prescriptions refilled, and require pharmacists to double-check that women are properly screened before handing over the pills.

The registry cannot make women comply with the contraception guidelines. It's impossible to control what patients do once the prescription has been filled.

Accutane is not for everybody, and it is not a first-choice therapy because in many cases you can have effective treatments without this risk.