Some don't heed warnings of acne drug danger during pregnancy conception

iPLEDGE mandates pregnancy test for women who want a prescription for isotretinoin

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 US become pregnant while taking it, a new study shows.

The program, dubbed iPLEDGE, which was started in 2006 by the Food and Drug Administration, requires women who want a prescription for isotretinoin to use birth control or promise to abstain from intercourse and to take a pregnancy test before starting the drug and every month thereafter.

While the program may have reduced the number of pregnancies in women who take the drug, the number hasn’t been reduced to zero, according to the study published in JAMA Dermatology. 

“This drug is really life changing for those with severe acne that is resistant to everything else,” said study coauthor 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. I think of this as an opportunity to study the situation and to think about how we can improve the delivery of this medication to patients in the safest way possible.”

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

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. 

reuters