GlaxoSmithKline has agreed to pay $460 million to settle most of the lawsuits filed against its drug Avandia (Rosiglitazone).
The medicine, an antidiabetic, could cause heart attacks: the story led 13,000 customers to turn to the law for compensation. Now the pharmaceutical giant has announced that it has reached an agreement with about 10,000 people: each will receive about 46,000 dollars.
14-07-2010 Il Sole 24 Ore p. 45
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The diabetes drug Avandia: the FDA's position as of February 2010
The Food and Drug Administration (FDA) is reviewing data from a large study on the possible risk of the diabetes mellitus drug Avandia ( Rosiglitazone ).
The Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes ( RECORD ) clinical study was designed to evaluate the cardiovascular safety of rosiglitazone.
In addition to the RECORD study, a number of observational studies regarding the cardiovascular safety of rosiglitazone have been published, and are now being reviewed by the FDA.
To date, the FDA has not made any decisions or recommendations regarding the drug Avandia for the treatment of type 2 diabetes.
Once the FDA completes the data analysis of the RECORD study, the results will be presented at the Meeting of the Endochronologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committee in July 2010.
In that session the Panel of Experts will evaluate the risk-benefit ratio of Rosiglitazone.
The FDA recommends that physicians follow the instructions contained in the data sheet; patients should continue taking rosiglitazone unless their doctor intends to stop the therapy. Patients who fear the possible risks associated with the drug should talk about it c
