It's been a long, strange trip for the drug that was approved in 1999 to lower blood sugar in patients with type 2 diabetes and is sold under a number of brands, including Avandia
, Avandamet, and Avandaryl, as well as generics.
In November 2007 the FDA extended the warning to cover an increased risk for myocardial infarction, based on "a meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia
to placebo [and] showed Avandia
to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.
The Food and Drug Administration is lifting restrictions on the use of GlaxoSmithKline Plc's diabetes drug Avandia
after determining that its use did not increase the risk of heart attacks.
Food and Drug Administration (FDA) has eased restrictions on patient access to Avandia
(rosiglitazone), following an FDA Advisory Committee review in June 2013.
British drug maker GlaxoSmithKline has agreed to stump up millions of dollars settlement fee, in order to end a raft of lawsuits with eight US states, over improper marketing of its Avandia
A drug firm are trying to block legal aid for a former DJ who plans to sue over their banned diabetes medication Avandia
GlaxoSmithKline has agreed to pay $3 billion to the federal government and plead guilty to charges of illegally promoting two antidepressants and withholding key safety information about the diabetes drug Avandia
The London-based pharmaceutical giant admits in a charging document that it didn't report safety data of its Avandia
diabetes drug to regulators, unlawfully marketed Wellbutrin for weight loss and other purposes for which it wasn't approved by U.
The actions related to the sales and marketing of anti-depressants Paxil and Wellbutrin, the Medicaid Rebate Program, and the Department of Justice's investigation into the development and marketing of diabetes drug Avandia
Vioxx and Bextra, known as cyclo-oxygenase-2 (COX-2) inhibitors, were withdrawn from the market because of safety concerns over heart attacks and strokes, and Avandia
has been suspected in some reports of increasing the risk of heart attacks.
The political angst now expressed concerning just one of the drugs, GlaxoSmithKline's Avandia
, is dreadfully late--coming a decade after FDA medical reviewer Robert I.
DRUGS giant GlaxoSmith-Kline took a pounds 147m hit after writing off stocks of its controversial diabetes drug Avandia