FDA issues warnings for Rezulin
Reports of liver problems associated with the new diabetes drug Rezulin have prompted the U.S. Food and Drug Administration in Rockville, MD, to issue new warnings about the drug.
The FDA said that doctors should monitor and measure liver enzyme levels in their patients taking the drug Rezulin for diabetes. Doctors should measure these levels at the start of the drug therapy and continually measure the levels at least monthly to ensure no liver damage is taking place.
Known generically as troglitazone, the drug has reportedly caused liver failure in some people and three known deaths. Currently, 600,000 people in the United States and 200,000 people in Japan have taken the drug.
Parke-Davis, of Morris Plains, NJ, the maker of Rezulin, has also been told to display information about possible liver damage more prominently on the drug label.