- It's long been known that the highly effective acne medication isotretinoin - marketed as Accutane and Roaccutane - is tied to the risk of severe 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 U.S. become pregnant while taking it, a new study shows.
"This drug is really life changing for those with severe acne that is resistant to everything else," said study coauthor Dr. Arash Mostaghimi, an assistant professor of dermatology at Harvard Medical School and Brigham and Women's Hospital."Even those who have had very mild acne can think about how it impacted them. Imagine how impactful it would be if it was severe and caused permanent scarring.
The researchers found reports of 6,740 pregnancies among women taking isotretinoin between 1997 and 2017, which peaked at 768 pregnancies in 2006 and then began to decline, plateauing in 2011 at 218 to 310 per year. Among women of childbearing age who were registered for iPLEDGE in 2006 and 2009 to 2010, the pregnancy rates ranged from 33 per 10,000 to 65 per 10,000.Just 41per cent of the reports included the woman's age.