According to the findings of a report prepared by the United States Senate Committee on Finance the manufacturer of rosiglitazone failed to warn patients or regulatory authorities of cardiovascular concerns. This publication has been reported in the British Medical Journal.
A two year investigation has reviewed over 250,000 documents submitted by GlaxoSmithKline, the Food and Drugs Administration (FDA) and other organisations after the publication of a study in the New England Journal of Medicine that raised concerns that rosiglitazone increased the risk of myocardial infarction.
This investigation found that the manufacturer of rosiglitazone knew for several years prior to this study that there were possible cardiac risks associated with [rosiglitazone] Avandia®. Additionally, independent physicians were intimidated, the risks were misrepresented and positive results for competing drugs were downplayed.
Finally, this investigation is critical of the role played by the FDA. The FDA requested a cardiovascular safety trial be conducted however internal FDA documents note that two safety officials conducted an analysis of the available data at that time and concluded that any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative.
Action: As previously advised, clinicians should continue to implement the existing guidelines. Glitazones (and gliptins) are considered as alternatives to metformin or sulphonylureas when these agents are contraindicated or poorly tolerated. Pioglitazone currently has fewer prescribing restrictions and may be a better choice where a glitazone is indicated.
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