Healthy Skepticism Library item: 10492

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Publication type: Journal Article

Kazi D.
Rosiglitazone and implications for pharmacovigilance
BMJ 2007 Jun 16; 334:(7606):1233
http://www.bmj.com/cgi/content/full/334/7606/1233

Abstract:

Postsurveillance data should be systematically collected, timely, and publicly available

On 21 May 2007, the New England Journal of Medicine published a meta-analysis of 42 trials of rosiglitazone (Avandia, GlaxoSmithKline) for treating type 2 diabetes mellitus. It found that the drug was associated with an increased risk of myocardial infarction (odds ratio 1.43; 95% confidence interval 1.03 to 1.98; P=0.03) and death from cardiovascular causes (1.64; 0.98 to 2.74; P=0.06).1

Rosiglitazone, a thiazolidinedione, is an agonist at the peroxisome-proliferator activated receptors in cell nuclei. These receptors modulate the expression of a host of genes, and glycaemic control is achieved primarily through increased insulin sensitivity in peripheral tissues. Rosiglitazone was approved by the US Food and Drug Administration (FDA) in 1999 and by the centralised process of the European Medicines Agency (EMEA) in 2000. Its popularity has increased steadily, with more than one million prescriptions written in the one year period ending March 2006 in England alone-a 22% increase over the . . .