TY  - JOUR
T1  - IOm urges fda to be more aggressive in monitoring safety of approved drugs
AU  - Kuehn BM
Y1  - 2012/06/20
N1  - 10.1001/jama.2012.5993
JO  - JAMA
SP  - 2475
EP  - 2476
VL  - 307
IS  - 23
N2  - 
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).

SN  - 0098-7484
M3  - doi: 10.1001/jama.2012.5993
UR  - http://dx.doi.org/10.1001/jama.2012.5993
ER  -