Key Points

Question  What is the scope of pregnancy-related adverse events associated with isotretinoin reported to the US Food and Drug Administration?

Findings  In this analysis of pregnancy-related adverse events associated with isotretinoin reported to the US Food and Drug Administration, there were 6740 total pregnancies among women exposed to isotretinoin reported from 1997 to 2017, peaking with 768 pregnancies at the 2006 initiation of the iPLEDGE program, for a rate of 0.65% per female of childbearing potential (768 of 117 784). 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.

Meaning  Although the number of reports of pregnancies among women taking isotretinoin has decreased from peaks in the mid-2000s, these pregnancies persist in the iPLEDGE era.

 

CC0 Creative Commons, Pixabay

Read more…