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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY February 2018 | Archived Issues

FDA Issues Warning About Incorrect Dosing of Obeticholic Acid

The U.S. Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate-to-severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, the FDA is clarifying the current recommendations for screening, dosing, monitoring and managing PBC patients with moderate to severe liver disease taking Ocaliva.

The FDA website has more information.

FDA: Agency Seeks Packaging Limits for Anti-diarrhea Drug Loperamide

In an effort to foster safe use of the over-the-counter anti-diarrhea drug loperamide, the FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. The agency continues to receive reports of serious heart problems and deaths linked to much higher than recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product. Loperamide is a safe drug when used as directed and helps control symptoms of diarrhea.

The FDA website has more information.