FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone

Michael O’Riordan

Heartwire 2008. © 2008 Medscape

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.