US Food and Drug Administration Reports of Pregnancy and Pregnancy-and Pregnancy-Related Adverse Events Associated With Isotretinoin

iPLEDGE is a program initiated in 2006 in US to reduce foetal exposure to isotretinoin (IS). Study found that although number of reports of pregnancies, abortions, and foetal defects among women on IS has decreased since peaking around initiation of Ipledge, all 3 persist.

There were 6740 pregnancies among women taking isotretinoin reported to the FDA from 1997 to 2017, peaking in 2006 (768 pregnancies) before settling into a range of 218 to 310 annual reports of pregnancy after 2011.

 

An editorial notes that although the study does not allow conclusions to be drawn about iPLEDGE’s efficacy, one basic conclusion is very clear: foetal exposure persists at unacceptable levels. It acknowledges that programs such as iPLEDGE must strike a careful balance between preserving access to medication and ensuring that the medication is used safely.