Important FDA Safety Alerts in GI: What you need to know

Boxed warning for Ocaliva (obeticholic acid) The U.S. Food and Drug Administration (FDA) issued a warning this week stating that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients ...

Recent FDA Safety Alerts Impacting GI

On Tuesday, June 7th, the FDA warned the public about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium): taking higher than recommended doses of both the non-prescription, over-the-counter (OTC) and prescription ...

FDA Updates Guidance: How to Request Domperidone for GI Disorders

ACG continues to work with the FDA in helping members obtain access to domperidone for patients.  As you know, domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. On June 7, 2004, FDA issued ...