Isotretinoin, better known as Accutane, can cause severe harm to a developing fetus. Isotretinoin belongs to a class of drugs known as retinoids and works by reducing the production of certain compounds known to contribute to acne. There are pregnancy prevention guidelines, but a study in Canada suggests that many women are not adhering to the guidelines.
The US Food and Drug Adminstration (FDA) launched the iPledge program with the goal of reducing fetal exposure to isotretinoin. Patients must be registered to iPledge and fill out an informed consent form before using the drug. Only prescribers and pharmacists registered to the program are permitted to prescribe and dispense the drug. In addition, women of reproductive age must have two negative pregnancy tests before they can use isotretinoin and use two forms of contraception.
Similarily, Canada has a program in place that requires informed written consent, two pregnancy tests with negative results prior to use and two reliable forms of contraception during treatment.
When health records were analyzed in a 15-year study period, the researchers identified 1,473 pregnancies. 8% resulted in live births with 9% of these live births having congenital abnormalities. 1,041 of the pregnancies were ended with abortion, while 290 were spontaneous losses.
The study suggests that up to 50 percent of women in Canada ignore the guidelines resulting in birth defects, miscarriages and pregnancy terminations. A high percentage of women, 25-30 percent, failed to fill birth control prescriptions while using the drug.
In other words, pregnancy termination rather than pregnancy prevention is used to manage fetal risk from isotretinoin, rather than adherence to guidelines. Clearly modifying contraceptive behavior is a difficult task in this setting.
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Pregnancy guidelines for harmful acne drug not adhered to by many women
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