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Medical News & Perspectives
June 20, 2012

IOM Urges FDA to Be More Aggressive in Monitoring Safety of Approved Drugs

JAMA. 2012;307(23):2475-2476. doi:10.1001/jama.2012.5993

The Institute of Medicine (IOM) has urged the Food and Drug Administration (FDA) to be more proactive in dealing with safety concerns that emerge after a drug is on the market. The recommendation was issued as part of a final report on postmarketing safety from the IOM released in May (http://tinyurl.com/cxovshm).

The FDA requested the report as it considered what actions it should take to curb cardiovascular adverse effects linked with use of the diabetes medication rosiglitazone. The IOM committee charged with drafting the report submitted a brief preliminary version to the FDA during the deliberations in July 2010. Ultimately, the FDA and its European counterpart decided to greatly limit the use of rosiglitazone. In September 2010, the FDA announced changes to the labels on rosiglitazone-containing products to indicate they should be prescribed only 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 (http://tinyurl.com/66gtzq3).