FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone

April 09, 2008

April 9, 2008 (Research Triangle Park, NC) – The Food and Administration (FDA) has reprimanded GlaxoSmithKline (GSK) for failing to report all of its postapproval data on rosiglitazone (Avandia), the company's diabetes drug [1]. Rosiglitazone has been in the line of fire since May 2007, when a meta-analysis showed a significant increase in the risk of MI and an increase in cardiovascular death of borderline significance with the thiazolidinedione.

In a letter sent to Dr Jean-Pierre Garnier, chief executive officer of GSK, the FDA said an inspection in late 2007 focusing on compliance with postmarketing adverse drug experience reporting requirements found that the company "failed to report data relating to clinical experience, along with other data and information." The inspection revealed that the company failed to report multiple postmarketing studies involving rosiglitazone in periodic and/or annual new drug application reports.

In the FDA letter, dated March 25, 2008 and posted on the FDA website yesterday, the agency notes that nine studies were not disclosed until September 2007 and another 11 studies were not included in required annual reports, although some data were submitted to the agency in other reports or communications.

"The specific violations noted in this letter are serious and may be symptomatic of underlying postmarketing safety reporting failures," warns the FDA.

On its website [2], GSK acknowledged the receipt of the FDA letter on regulatory reporting, noting the warning letter relates to missing information such as the start and progress of clinical trials and summaries of final data from clinical trials. GSK issued a press release stating that corrective steps are being taken to "make sure we file periodic reports completely and promptly." The company said the omissions did not interfere with the timely reporting of adverse-event information to the FDA.

In November 2007, as previously reported by heartwire , the FDA decided to allow rosiglitazone to stay on the market with increased warnings about the risk of cardiovascular events, while further studies were conducted to investigate the issue. An additional statement was added to the existing boxed warning on the product's labeling, noting that a meta-analysis of 42 clinical studies, most of which compared rosiglitazone with placebo, showed rosiglitazone to be associated with an increased risk of myocardial ischemic events such as angina or MI. The label notes that other studies have not confirmed this risk, and that available data on the risk of myocardial ischemia is inconclusive.

  1. FDA. Warning letter. March 25, 2008. Available at: http://www.fda.gov/foi/warning_letters/s6714c.htm .

  2. GlaxoSmithKline. GlaxoSmithKline confirms receipt of FDA letter on regulatory reporting [press release]. April 8, 2008. Available at: .

The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.



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