Tag: GSK

Diabetes Drug Maker Hid Study Data


Avandia Safety Questioned:  The New York Times reports that diabetes drug maker SmithKline did not reveal the results of a study showing its drug Avandia was riskier to the heart than a competing drug, Actos. The New York Times states, “instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.” Experts...



Avandia Recall Possible: FDA Reviews


The diabetes drug, Avandia, may be more dangerous than was previously reported.  According to CNN,  a review of Avandia released last week by the FDA states that officials overseeing GlaxoSmithKline Plc’s RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients — including reports of patient deaths. Next week an FDA panel will debate a series of steps that could include removing Avandia from the market. Avandia is used to control blood sugar levels in diabetics, but its...



GSK Rejects Allegation Regarding Avandia Safety


GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance report regarding Avandia. GSK said it rejects any allegations of concealing safety information or acting inappropriately on behalf of patients.  GSK also said it disagrees with the Committee’s decision to publish a Staff Report with the errors of fact, omissions, and inferences detailed in GSK’s White Paper. GSK stated that it stands behind the safety of Avandia. GSK also denied reports claiming the FDA had called for withdrawal of Avandia,...



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