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Isotretinoin-exposed pregnancies, fetal defects still an issue after iPLEDGE implementation

Pregnancies, abortions and fetal defects associated with isotretinoin exposure continue to be a problem even though the number of pregnancy-related adverse events has decreased since 2006, according to a retrospective analysis of FDA reports.

“Explanations for this trend include a broader national decrease in teenage pregnancies and abortion rates, improvements in access to effective long-term and emergency contraceptive, stringent iPLEDGE requirements and reporting fatigue over time,” Priyank Sharma, MD, of the department of dermatology at Brigham and Women’s Hospital in Boston, and colleagues wrote.

The iPLEDGE program, implemented in 2006 to reduce fetal exposure to isotretinoin, requires registration of wholesalers, clinicians and pharmacies who provide isotretinoin, as well as patients with a prescription for isotretinoin. Female patients of childbearing potential must have a negative pregnancy test and verify two forms of contraception.

The FDA Adverse Event Reporting System was searched for pregnancy-related adverse events related to isotretinoin from 1997 to 2017. A total of 6,740 pregnancies were reported during this time frame, which peaked in 2006 with 768 pregnancies. After the introduction of iPLEDGE in 2006, 4,647 pregnancies (68.9%) were reported.

In 2008, there was a peak of 291 abortions and 64 pregnancies that occurred while taking contraception, but all pregnancies and abortions have decreased since then.

There were 1,896 abortions (28.1%) from 1997 to 2017; 733 (10.9%) were spontaneous abortions.

Fetal defects peaked at 34 in 2000 and ranged between zero and four annually after 2008, the researchers reported.

A total of 41.3% of the reports included patient age, which was a mean was 24.6 years. The highest rate of reported pregnancies, therapeutics abortions and spontaneous abortions occurred among patients aged 20 to 29 years. The pregnancy rate has been consistent since 2011.

“If iPLEDGE were the primary reason for the decreasing number of pregnancies among women taking isotretinoin, then a decrease in the pregnancy rate would have been identified sooner after the implementation of iPLEDGE,” Sharma and colleagues wrote. – by Abigail Sutton

Disclosures: Sharma reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.