RT Journal
A1 Kuehn BM
T1 IOm urges fda to be more aggressive in monitoring safety of approved drugs
JF JAMA
JO JAMA
YR 2012
FD June 20
VO 307
IS 23
SP 2475
OP 2476
DO 10.1001/jama.2012.5993
UL http://dx.doi.org/10.1001/jama.2012.5993
AB 
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).