The U.S. FDA has lifted certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine.
Tag: Avandia
The results of a randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in children with type 2 diabetes show that children and adolescents treated with a combination of metformin and Avandia (rosiglitazone) had better glycemic control than children....
It seemed like such an elegant solution at the time; activate the transcription of a glucose transporter in an insulin independent fashion. The…
Following an ongoing FDA review of the diabetes drug Avandia (rosiglitazone) the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class...
The continuing controversy surrounding the cardiovascular risk of GlaxoSmithKline's diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug, Actos. Although the drugs are similar and both had FDA warnings in 2007, Takeda's Actos has been...
GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14...
GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions...
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 ...
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...
According to a new report published in the Lancet, taking a low dose of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) combined with metformin was highly effective in prevention of type 2 diabetes in patients with impaired glucose tolerance, with little effect on the clinically relevant adverse events of these two drugs.
The study included 207 patients with impaired glucose...