Pregnancies in Women Taking Isotretinoin Dropped Since 2006

Since initiation of the iPLEDGE program in 2006 to reduce fetal exposure to isotretinoin, there has been a reduction in pregnancies among women taking isotretinoin, although exposure still persists, according to a report published online in JAMA Dermatology.

Elizabeth Tkachenko, from the University of Massachusetts Medical School in Worcester, and colleagues examined the frequency and rate of pregnancy and pregnancy-related adverse events among women taking isotretinoin. A retrospective analysis of pregnancy-related adverse events associated with isotretinoin was conducted using pregnancy reports from the U.S. Food and Drug Administration Adverse Event Reporting System.

The researchers identified reports of 6,740 pregnancies among women taking isotretinoin from 1997 to 2017. The number of these reports peaked in 2006 (768 pregnancies) and varied from 218 to 310 annual reports of pregnancy after 2011. For women of childbearing potential, the rate of pregnancy varied from 0.33 to 0.65 percent, peaking in 2006. Since initiation of iPLEDGE in 2006, pregnancies, abortions, and fetal defects have decreased among women taking isotretinoin, but all three persist.

"Further research is required to determine the most efficacious system to reduce complications for patients and administrative requirements for physicians while at the same time maintaining access to this important drug," the authors write.

Two authors disclosed financial ties to Pfizer, and one disclosed ties to HIMS Inc.

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