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A unique pregnancy prevention program.

The more successful a new drug, however it is used, the more important it is to know what effect, if any, it has on an unborn child. As a result of the large numbers of women, particularly teenage mothers, now being recognized as having inadequate prenatal care, such precaution becomes particularly important.

One of the most distressing features of teenage life is acne, and with the advent of the antiacne drug isotretinoin (Accutane) eight years ago, the most severe cases of cystic acne, which almost inevitably led to permanent scarring, could now be successfully treated for the first time. Because of these dramatic results, Accutane has enjoyed huge success. However, in spite of its known potential for producing birth defects (and package label warning against its use in pregnancy), cases of fetal defects and spontaneous abortions began to appear within the first year. Since then, the drug's New Jersey-based manufacturer, Roche Dermatologics, has collaborated with the FDA in a massive effort to prevent possible pregnancies in women using the drug.

In 1988, the company began its "Pregnancy Prevention Program for Women on Accutane," which has only been fully implemented in the past 18 months. The program includes such items as packaging with warnings and pictures, patient consent forms, pregnancy prevention kits for physicians (including patient educational materials), and a label stating that a negative serum pregnancy test is required within two weeks prior to beginning treatment (which should begin only on the second or third day of the next menstrual period). Although nothing like this has ever been tried before, the manufacturer is so enthusiastic about the program that it has also initiated, with the FDA's approval, even more educational and preventive efforts. These include a videocassette to be played in the physician's office, referrals to obstetricians for pregnancy testing, consent forms in foreign languages, and the manufacturer's assurance that patients return all unused medication to prevent it from being given to a friend.

Although this sounds like a lot of to-do over one simple acne medication, the alternative would have been to remove the drug from the market entirely. This would have done an enormous disservice to the large number of patients receiving benefits not available before. It is encouraging to see what can be accomplished when government chooses to collaborate with a drug manufacturer and the medical profession, rather than simply forbid use of a highly useful, albeit potentially dangerous, agent.
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Title Annotation:Roche Dermatologics' Pregnancy Prevention Program for Women on Accutane
Publication:Medical Update
Date:Jan 1, 1991
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