Drugs

Thiopurine Alert on Intrahepatic Cholestasis of Pregnancy

FDA has issued a safety alert on the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine, 6-mercaptopurine, and 6-thioguanine), immunosuppressants with a known risk of hepatotoxicity and currently labeled about the risk of fetal harm when used during pregnancy. “Pregnant patients should stop using thiopurines if they develop ICP,” the alert says. FDA is requiring manufacturers to update labeling to include additional warning information about the issue.

FDA is requiring all NDA/ANDA holders for the affected drug products to include the following in updated labeling:

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.

The agency says reported ICP cases have occurred among pregnant patients using azathioprine or 6-mercaptopurine primarily to treat inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Thiopurines are not FDA-approved to treat these conditions, but the agency notes that 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 managing some immunologic conditions during pregnancy.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome