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- Title
Critics Press FDA to Act on Evidence of Rosiglitazone's Cardiac Safety Issues.
- Authors
Mitka, Mike
- Abstract
In this article, the author discusses the oversight of the U.S. Food and Drug Administration (FDA) over safety issues surrounding the rosiglitazone drug as of June 16, 2010. Critics reference findings from several meta-analyses and observational studies which showed that the drug is associated with increased risk of myocardial infarction and cardiovascular death. It presents the counterarguments of the drug's manufacturer, GlaxoSmithKline, against conclusions reached by the Senate Finance Committee. Issues surrounding the Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial are also considered.
- Subjects
UNITED States; LEGISLATIVE oversight; UNITED States. Food &; Drug Administration; MEDICATION safety; ROSIGLITAZONE; MYOCARDIAL infarction; GLAXOSMITHKLINE
- Publication
JAMA: Journal of the American Medical Association, 2010, Vol 303, Issue 23, p2341
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2010.788