FDA advisory panel votes to keep Avandia
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FDA advisory panel votes to keep Avandia After two days of hearings, the US FDA’s advisory panel has voted to allow rosiglitazone [Avandia] to remain on the market.1 The joint advisory committee* voted on recommendations from making no changes to the current label, to revising the label with additional warnings and restrictions, or completely withdrawing the drug from the US market.1 Overall, the advisory committee voted 20 to 12 (with one abstention) to keep rosiglitazone on the market. The committee also voted 20 to 10 (with two abstentions) for the continuation of the TIDE trial – a trial requested by the FDA to evaluate the long term effects of rosiglitazone in type 2 diabetes mellitus patients at risk of cardiovascular disease.2 The FDA will now consider the committee’s recommendations and make a final ruling.2 Meanwhile, the personal injury law firm Parker Waichman Alonso LLP is investigating allegations, from the New York (NY) Times, that the manufacturer attempted to conceal information about rosiglitazone’s cardiovascular side effects.3 According to an article published in the NY Times on 12 July 2010, SmithKline Beecham – which later became GlaxoSmithKline (GSK) – failed to submit to federal regulators negative findings from a study comparing rosiglitazone with pioglitazone [Actos].4 The Times revealed an email from a SmithKline executive, stating "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK". Similarly, a company official queried the publishing of data from other studies comparing rosiglitazone with glibenclamide [glyburide], and the same senior executive responded by emailing, "Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG [rosiglitazone] monotherapy arm."4 In response to the newspaper’s allegations, GSK commented that Avandia is safe and that particular senior executive no longer works for the company.4 * The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee 1. GlaxoSmithKline. GlaxoSmithKline Statement in Response to FDA Advisory Committees′ Vote on Safety of Avandia (rosiglitazone). Media Release : 14 Jul 2010. Available from: URL: http://us.gsk.com. 2. American Heart Association. American Heart Association Comment: Advisory Committee Recommends that U.S. Food and Drug Administration Keep Rosiglitazone (Avandia) on the Market, Continue Clinical Trial of Safety and Efficacy. Media Release : 14 Jul 2010. Available from: URL: http:// www.americanheart.org. 3. Parker Waichman Alonso LLP. Parker Waichman Alonso LLP Demands GlaxoSmithKline Pull Avandia from the Market Immediately Due to Company’s Attempt to Hide Deadly Safety Concerns. Media Release : 14 Jul 2010. Available from: URL: http://www.businesswire.com. 4. New York Times. Diabetes drug maker hid test data, files indicate. Internet Document : [3 pages], 12 Jul 2010. Available from: URL: http:// www.nytimes.com. 801140687
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