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GlaxoSmithKline received FDA warning letter about rosiglitazone

Letter alleges company has not followed reporting requirements for the drug.

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GlaxoSmithKline has confirmed receipt of a warning letter from the FDA on March 25 related to reporting requirements for rosiglitazone.

According to the FDA warning letter, GlaxoSmithKline failed to report clinical experience data for rosiglitazone (Avandia) in more than 10 ongoing studies between 2001 and 2007. Current federal regulations require that companies report such data.

The FDA said these violations are “serious and may be symptomatic of underlying post-marketing safety reporting failures.”

This letter follows a routine FDA inspection of GlaxoSmithKline’s reporting processes between Aug. 20, 2007 and Nov. 13, 2007.

“We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway,” Ronald Krall, MD, chief medical officer, GlaxoSmithKline, said in a press release. “These omissions did not interfere with the timely reporting of adverse event information to the FDA.”

The FDA’s claims are related to information on the start and progress of clinical trials, summaries of final clinical trial data and processes for reporting individual adverse events. The information that GlaxoSmithKline submitted to the agency was not in periodic reports, but rather other modes of communication, such as postings on ClinicalTrials.gov, according to the FDA.

The letter urged GlaxoSmithKline to “take prompt action to correct the violations” and said that “failure to do so may result in regulatory action without further notice.”

GlaxoSmithKline said it is committed to taking the appropriate steps to address the concerns raised by the FDA, according to the press release.

A meta-analysis published last year in the New England Journal of Medicine revealed that rosiglitazone was associated with an increased risk for myocardial infarction and risk of death from cardiovascular causes. – by Katie Kalvaitis