Women Still Get Pregnant on Acne Medication Accutane Despite Warnings About Birth Defects


It has long been known that isotretinoin, a highly effective acne medication marketed under the names Accutane and Roaccutane, is linked to the risk of serious birth defects. But even with a special program in place to prevent conception in women taking the drug, each year two to three hundred women in the United States become pregnant while taking it, according to a new study.

The program, dubbed iPLEDGE, which was started in 2006 by the United States Food and Drug Administration, requires women who want a prescription for isotretinoin to use a contraceptive or to promise to abstain from sex and pass a pregnancy test before starting the medicine and every month. after.

While the program may have reduced the number of pregnancies among women taking the drug, the number has not been reduced to zero, according to the study published in JAMA Dermatology.

“This drug is truly life changing for people with severe acne that is resistant to everything else,” said study co-author Dr Arash Mostaghimi, assistant professor of dermatology at Harvard Medical School and Brigham. and Women’s Hospital. “Even those who have had very mild acne can think of the impact it has on them. Imagine how much of an impact it would have if it were severe and caused permanent scarring. I see this as an opportunity to study it. situation and think about how we can improve the delivery of this drug to patients in the safest way possible. “

To take a closer look at the impact of iPLEDGE, Mostaghimi and her colleagues combed through data from the FDA’s Adverse Event Reporting System, which collects information on adverse events reported by healthcare providers. , consumers and manufacturers.

Researchers found reports of 6,740 pregnancies in women taking isotretinoin between 1997 and 2017, which peaked at 768 pregnancies in 2006, then began to decline, peaking in 2011 at 218 to 310 per year. Among women of reproductive age enrolled in iPLEDGE in 2006 and 2009-2010, pregnancy rates ranged from 33 per 10,000 to 65 per 10,000.

Only 41 percent of the reports included the woman’s age. Among these reports, the average age of women who became pregnant was 24.6 years. Overall, women aged 20 to 29 accounted for the highest number of reported pregnancies (1,510), therapeutic abortions (317) and miscarriages (227).

Minimize unwanted pregnancies

Mostaghimi hopes the discussion about isotretinoin doesn’t scare people with severe acne. “I have seen such an improvement in people’s lives,” he said.

The number of pregnancies among women who take isotretinoin is unlikely to ever drop to zero, said Dr Hyagriv Simhan, vice president of obstetrics at UPMC Magee-Womens Hospital in Pittsburgh.

“No system is perfect,” said Simhan, who was not involved in the new research. “But incorporating decision support so that doctors prescribing this drug can ask the right questions would go a long way in minimizing the number of unplanned pregnancies. Contraception is not perfect. But I think we could use it much better. than we are. “

Because Accutane can damage the head, face, heart, central nervous system, and limbs of a fetus, prescribing information in Canada requires the patient’s written consent, two negative pregnancy tests prior to treatment, and the use of two reliable methods of contraception for women. of childbearing age.

In 2016, Canadian researchers also concluded that despite the strict guidelines, there were many failures in preventing pregnancy.


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