Accutane. (Drugs, Pregnancy, and Lactation).

Accutane (isotretinoin), a vitamin A derivative, is probably the most teratogenic drug on the market today. The Organization of Teratology Information Services has reported a marked increase in the number of Accutane-exposed pregnancies in the last several years.

This issue has led to renewed pressure on the Food and Drug Administration and Roche, the drug's manufacturer, to do more to prevent Accutane-exposed pregnancies and strengthen the existing Pregnancy Prevention Program for Women on Accutane. The System to Manage Accutane-Related Teratogenicity (SMART) will have some impact in reducing exposed pregnancies (see related stories on this page), but unless we provide much more education about family planning and effective contraception, I am not sure how effective the program will be.

If this program is not adequate, the next step, according to the FDA, will be to require registration of patients and prescribers. I believe we will end up with such a registry which will mean much tighter control over the drug.

One of the stipulations of SMART is that a patient has to have two negative pregnancy tests and receive pregnancy prevention counseling before the prescription is filled; the test needs to be repeated every month before the prescription is refilled. Physicians must sign a letter saying they will refer patients for contraceptive counseling or provide it themselves, It is unrealistic to assume that this step by itself will bring about a solution. Some women who test negative conceive while on treatment. What patients tell us here at the Motherisk program is that they didn't plan the pregnancy which is often a result of unplanned and unprotected sexual activity We published a study of exposed cases, which showed that most women who became pregnant during therapy acknowledged they knew the drug was not safe during pregnancy.

Clearly the obstetrician can play an important role in prescribing and in counseling women who are going to take Accutane about effective use of contraception. For such patients, it is reasonable to consider the highly effective injectable contraceptives as the primary method, which can cover several months of treatment. For example, a reasonable approach would be to administer the monthly injection after every negative pregnancy test. Norplant, which can be removed at any time, is also a reasonable choice.

Accutane's label ...