GlaxoSmithKline initiated a shield for its diabetes drug Avandia on Wednesday with a detailed 30-page response rejecting a critical report by U. S. lawmakers.
GSK posted that it had been pondering into potential safety concerns throughout Avandia’s tenure on the market, and that, till now, no conclusive studies relating the drug to high vulnerability of heart attacks has been found.
The FDA has disapproved the drug with a black box warning and made GSK initiate another study of the potential link, and that seemed to be that.
The drugmaker reported the Senate finance committee report did not posted an accurate, balanced, or complete set of information relating the drug and the company disapproved allegations it had concealed safety data
(link. reuters. com/bar62j).
In a letter to FDA Commissioner Margaret Hamburg, committee chairman Sen. Max Baucus (D-MT) and ranking member Sen. Chuck Grassley (R-IA) quoted, “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public”.
A spokeswoman for Glaxo, which issued a press issued on Feb. 20 annulling the committee's conclusion that Avandia was not safe, posted the lengthy "white paper" was the company's official response.












