Healthy Skepticism Library item: 18644
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Cohen D
Rosiglitazone: what went wrong?
BMJ 2010 Sep 6; 341:
http://www.bmj.com/content/341/bmj.c4848.full
Abstract:
Over 10 years after the diabetes drug rosiglitazone was approved by regulators, and despite studies on tens of thousands of people, questions remain about its cardiovascular safety. An investigation by the BMJ looks at why this happened.
It was, as one Food and Drug Administration (FDA) adviser put it, a “perfect regulatory stormâ€-a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour.
Now, 10 years after its approval by regulators in the United States and Europe, the widely prescribed blockbuster diabetes drug rosiglitazone may be about to fold. Two months ago, in July 2010, the FDA convened a 33 member expert advisory panel to decide whether it should be withdrawn from the market in the light of evidence that it may increase the risk of myocardial infarction. Earlier this year a US Senate finance committee report had detailed concerns about the paucity of evidence to support the use of rosiglitazone and about the way in which the drug was evaluated and licensed.1 …
