Posted on 09/16/2007 1:04:01 AM PDT by neverdem
Two more studies published in yet another prominent medical journal have raised questions about the safety of Avandia, a once-popular diabetes medicine.
One study found that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent. A second study found that Actos, a similar drug made by Takeda, actually lowered the risks of heart attacks, strokes and death but, like Avandia, also raised risks of heart failure.
Taken together, some of the authors said, the two studies in The Journal of the American Medical Association confirm what doctors and patients using Avandia have already done in great numbers, that is, switch to another drug. Sales of Avandia have plunged.
GlaxoSmithKline said in a written statement that the studies were flawed and “offered no new information on the safety of Avandia.” The company “continues to support Avandia as safe and effective when used appropriately,” the statement said.
In July, a federal advisory panel voted overwhelmingly that Avandia should remain on the market even though it raised the risks of heart attacks. In June, the Food and Drug Administration said it would place its strictest warnings on the labels of both Avandia and Actos because of heart failure risks.
Riven by internal disagreements, the drug agency is still pondering further regulatory actions regarding Avandia. Some in the agency say that the drug should be withdrawn, while others say that...
--snip--
Dr. Solomon wrote that the Avandia situation should be used to improve the nation’s drug-safety system. Among his proposals is that when several drugs are available to treat a condition, new drugs must prove that they improve or extend people’s lives before they are approved. Now, many drugs are approved only after they improve laboratory results, like blood sugar or cholesterol levels.
(Excerpt) Read more at nytimes.com ...
Actos is pioglitazone. Avandia is rosiglitazone. The reviews are pertinent, but only abstracts are available in the "Reviews." I read the abstract of the FReebie about lowering homocysteine levels in patients with a history of chronic kidney disease. Too bad it doesn't seem to work.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.