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- Title
lOM Urges FDA to Be More Aggressive in Monitoring Safety of Approved Drugs.
- Authors
Kuehn, Bridget M.
- Abstract
The article focuses on a report released by the U.S. Institute of Medicine (IOM) which urges the U.S. Food and Drug Administration (FDA) to be more active regarding safety issues of previously approved drugs. The FDA asked for the report to check on what actions needs to be taken in order to curb cardiovascular adverse effects linked with use of the diabetes medication rosiglitazone. Following the report, the FDA limited the use of rosiglitazone and announced changes to the labels on the drug containing products that it should be only prescribed to patients currently using the drug or to patients who have been unable to control their blood glucose using other medications and who have been fully informed of the drug's risks.
- Publication
JAMA: Journal of the American Medical Association, 2012, Vol 307, Issue 23, p2475
- ISSN
0098-7484
- Publication type
Academic Journal
- DOI
10.1001/jama.2012.5993