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The use of thiopurines (eg, azathioprine, 6-mercaptopurine, and 6-thioguanine) by pregnant individuals has been linked to intrahepatic cholestasis of pregnancy (ICP), according to the Food and Drug Administration (FDA).
Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease (ulcerative colitis and Crohn disease) or systemic lupus erythematosus. While not FDA-approved to treat these diseases, some guidelines suggest azathioprine or 6-mercaptopurine may be appropriate on an individualized basis to manage certain immunologic conditions during pregnancy.
In response to these reports, the FDA is requiring manufacturers add additional warnings related to the risk of ICP with thiopurines. These include the following:
- Postmarketing cases of ICP have been reported in women treated with drugs in the thiopurine class during pregnancy.
- ICP symptoms and elevated bile acid levels improved following azathioprine discontinuation.
- Pregnant persons should discontinue use of thiopurines if they develop ICP.
Adverse events related to medication use should be reported to the FDA’s MedWatch program.
References:
US Food and Drug Administration. FDA alerts health care professionals of pregnancy problems associated with thiopurines. April 30, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-pregnancy-problems-associated-thiopurines.
