US Food and Drug Administration reports of pregnancy and pregnancy-related adverse events associated with isotretinoin
JAMA Oct 17, 2019
Tkachenko E, et al. - In this analysis, researchers ascertained the incidence and rate of pregnancy and pregnancy-related adverse incidents among women taking isotretinoin notified to the US Food and Drug Administration (FDA). A total of 6,740 pregnancies among women who were taking isotretinoin reported to the FDA from 1997 to 2017 was noted, which plateaued in 2006 (768 pregnancies) prior to reconciling into a range of 218 to 310 annual reports of pregnancy following 2011. For women of childbearing potential, with a plateau in 2006, the rate of pregnancy was between 0.33% (388 of 115,925) and 0.65% (768 of 117,784). In conclusion, among women who were taking isotretinoin, however, pregnancies, abortions, and fetal defects have reduced since the beginning of iPLEDGE in 2006, all three continue. Specifications for this trend incorporate a more extensive national reduction in teenage pregnancies and abortion rates, betterments in access to efficient long-term and emergency contraception, robust iPLEDGE demands, and informing fatigue over time. Moreover, irrespective of the reduction, steadfast reporting of pregnancy-related events in the last decade warrants research into the efficiency of iPLEDGE and the investigation of new strategies for decreasing fetal exposure to isotretinoin.
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