FDA warns of ‘rare risk’ for thiopurine-related intrahepatic cholestasis of pregnancy
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The FDA has issued a safety alert warning patients and health care providers of a “rare risk of intrahepatic cholestasis of pregnancy” linked to thiopurine use.
The safety alert follows reported cases of intrahepatic cholestasis of pregnancy (ICP) among patients who were administered azathioprine, 6-mercaptopurine or 6-thioguanine as treatment for inflammatory bowel disease including, ulcerative colitis and Crohn’s disease, or systemic lupus erythematosus.
“Thiopurines are immunosuppressants with a known risk of hepatotoxicity and are currently labeled for risk of fetal harm with use during pregnancy,” the agency stated in the alert. “However, the American Gastroenterological Association and the American College of Rheumatology have published treatment guidelines indicating that azathioprine or 6-mercaptopurine may be appropriate to continue on an individualized basis for management of some immunologic conditions during pregnancy.”
In response to these reports, the FDA required that thiopurine manufacturers update their drug labeling to include additional warnings regarding risk for ICP. Specifically, the agency requested that drug labels highlight that:
- Postmarketing cases of ICP have been reported in patients who received thiopurine during pregnancy.
- ICP symptoms and elevated bile acid levels improved after discontinuing azathioprine.
- Patients who are pregnant should discontinue thiopurine immediately following ICP development.
“Thiopurines are not FDA-approved to treat CD, UC or SLE,” the agency noted. “Pregnant patients should stop using thiopurines if they develop ICP.”
The FDA is also encouraging health care providers and patients to report adverse events related to thiopurine use to the administration’s MedWatch Safety Information and Adverse Event Reporting Program.
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