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FDA considers halting GSK drug Avandia safety trial

Posted April 19, 2010 6:27 a.m. EDT
Updated April 19, 2010 8:09 a.m. EDT

— The three-year debate about the safety of GlaxoSmithKline’s diabetes drug Avandia may be reaching a climax.

According to The Wall Street Journal, the U.S. Food and Drug Administration is “weighing whether to halt” the study. Such a decision “could also determine whether the drug stays on the U.S. market.”

In a letter sent to Iowa Senator Charles Grassley (R-Iowa), and reproduced at The WSJ Web site, the FDA Commissioner Margaret Hamburg said:

“FDA is concerned about the potential risk. In July, the Agency will present assessments of all available evidence on the cardiovascular safety of Avandia to a joint meeting of the Endocrinologic and metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This session will give a meaningful opportunity for all views to be heard and will lead to an assessment and decision by the Agency.”

Glaxo (NYSE: GSK), which maintains its U.S. headquarters in Research Triangle Park, has aggressively defended the safety of Avandia.

Grassley is among Avandia’s harshest critics.

The safety debate dates to 2007 when the risk of heart attack by Avandia users was stressed in a study. The FDA approved a trial comparing the safety of Avandia to another product called Actos.

“Some scientists inside and outside the FDA have said it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative,” the WSJ said. “They also say Avandia should be pulled from the market.”

In a statement, GSK is quoted by the newspaper as saying that it "welcomes additional scientific information that could help guide decisions around clinical trials and ultimately patient safety."