FDA reconsiders diabetes drug study



The U.S. Food and Drug Administration reportedly is considering suspending a safety review of the GlaxoSmithKline diabetes drug Avandia because of concerns that patients on the medication are at unnecessary risk for heart attacks and other heart problems.

In the first nine months of 2009, the drug was linked to more than 1,000 deaths from January through September, 2009, according to an analysis of reports filed with the FDA by the Horsham, Pa.-based Institute for Safe Medication Practices. The nonprofit group, which focuses on preventing medication errors, said that most of the deaths during those nine months were due to heart attacks, heart failure and strokes.

On Monday, Bloomberg News reported that the FDA is reassessing a study comparing Avandia with a rival medicine Actos from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news service said.

Even if the FDA halts the trial, the agency - which has been criticized as a weak regulator - might not pull Avandia off the market.

"If they decide to discontinue the comparison study, then, I think, they would be obliged to reexamine Avandia’s continuation on the market or at least give good reason why they won’t," said Daniel R. Hoffman, president of Pharmaceutical Business Research Associates in Chester County.

An independent data monitoring committee has so far "not expressed any concerns regarding the safety of participants in the study and has recommended that the study continue without modification," Glaxo spokeswoman Claire Brough said Monday in an e-mail to Bloomberg.

Avandia is Glaxo's brand name for the medication known as rosiglitazone. Last month a report by UBS analysts said that GlaxoSmithKline P.L.C. could be facing liabilities of as much as $6 billion from 13,000 personal-injury lawsuits relating to Avandia.