Boston—While the number of pregnancies has decreased, pregnancies among women taking the potent teratogen isotretinoin for acne have continued to persist despite a special restricted distribution program mandated by the FDA.

Isotretinoin, which was marketed under the brand names Accutane and Roaccutane, can help patients whose severe acne has not responded to other drugs, according to an article published online by JAMA Dermatology.

The downside, according to Brigham and Women’s Hospital–led researchers, is that taking the drug while pregnant, even for a short period of time, dramatically increases the risk of severe birth defects. In light of that, the FDA in 2006 required the iPLEDGE program, which includes stringent, recurring requirements for patients, prescribing physicians, and dispensing pharmacists.

The study team analyzed pregnancy-related adverse events associated with isotretinoin reported to the FDA and identified 6,740 total pregnancies among women exposed to isotretinoin reported from 1997 to 2017, peaking with 768 pregnancies at the 2006 initiation of the iPLEDGE program before settling into a range of 218 to 310 annual reports of pregnancy after 2011. Researchers calculated the overall rate as 0.65% per females of childbearing potential—768 of 117,784.

The brief report points out, “Although reports of pregnancies, abortions, and fetal defects have decreased since 2006, several hundred pregnancies among women taking isotretinoin have been reported annually in the last decade.”

Among women becoming pregnant while using isotretinoin, the mean age was 24.6, the article notes.

In explaining why the number of reports of pregnancies, abortions, and fetal defects among women taking isotretinoin has decreased since peaking around the initiation of iPLEDGE in 2006, researchers suggest “a broader national decrease in teenage pregnancies and abortion rates, improvements in access to effective long-term and emergency contraception, stringent iPLEDGE requirements, and reporting fatigue over time.”

Yet, they warn that the risk continues. Despite the decrease, persistent reporting of pregnancy-related events in the last decade warrants investigation into the efficacy of iPLEDGE and exploration of new approaches for lowering fetal exposure to isotretinoin,” the authors conclude.

“While the number of pregnancies among patients taking isotretinoin is low, even 200 pregnancies is too high,” explained corresponding author Arash Mostaghimi, MD, MPA, MPH, director of Dermatology Inpatient Service and codirector of the Complex Medical Dermatology Fellowship Program at the Brigham. “We need to think about regulations that can reduce that number without being overly burdensome for patients and physicians.”

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