Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
iPledge: Fetal Exposure to Isotretinoin Continues
Key clinical point: Pregnancies, abortions, and fetal defects in women treated with isotretinoin have declined since iPledge was implemented in 2006, but pregnancies are still occurring.
Major finding: Overall, of the 6,740 pregnancies in women on isotretinoin reported to the FDA from 1997 to 2017, 4,647 (68.9%) were reported since the iPledge program’s implementation in 2006, and pregnancy and abortion reports dropped after peaking in 2008.
Study details: A retrospective study of pregnancies and adverse events related to pregnancies among women taking isotretinoin reported to the FDA between 1997 and 2017.
Disclosures: One author reported support from an award by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and salary support from a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the trustees of the University of Pennsylvania, Philadelphia. The other authors reported no relevant conflicts of interest.
Tkachenko E et al. JAMA Dermatol. 2019. doi: 10.1001/jamadermatol.2019.1388.