Rep. Henry Waxman says ‘FDA dropped the ball’ with AvandiaJune 7, 2007 - The Food and Drug Administration has requested a black box warning for the labels of the type 2 diabetes medications Avandia, manufactured by GlaxoSmithKline, and Actos, manufactured by Takeda Pharmaceuticals, because of increased risk for congestive heart failure associated with the medications, agency Commissioner Andrew von Eschenbach announced on Wednesday at a House Oversight and Government Reform Committee hearing, the New York Times reports.Glaxo's Avandia May Raise Heart-Attack, Death RisksBy Michelle Fay CortezMay 21 (Bloomberg) -- GlaxoSmithKline Plc's drug Avandia, the world's top-selling oral diabetes treatment, may raise a patient's chance of having a heart attack, researchers said. Glaxo shares fell the most in four years. The finding reflects data from 42 studies involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo. Patients getting Avandia were 43 percent more likely to have a heart attack. The study also suggested a trend toward higher death rates in the Avandia group.
(accessed May 21, 2007, http://www.bloomberg.com/apps/news?pid=20601087&sid=av4TNXlcwujE&refer=home Avandia Linked to Heart Risks CNN article "(AP) -- The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday." Diabetes Drug tied to heart risk study CBS "Analysis Reveals Avandia Linked To 43 Percent Increased Risk For Heart Attack And Possibly Death" Avandia (351)Avandia decreases bone formation, may cause high risk of hip and other fractures (3/23/07) Avandia (352) "Although rosiglitazone, an insulin sensitizer, is known to have beneficial effects on high density lipoprotein cholesterol (HDL-C) concentrations and low density lipoprotein (LDL) particle size, it has unwanted effects on total cholesterol (TC) and LDL cholesterol (LDL-C) concentrations and body weight" (Clin Endocrinol. 2006;65(4):453-459 ) Rosiglitazone Reduces Microalbuminuria and Blood Pressure (337) "The investigators concluded that, when added to metformin, rosiglitazone provided greater improvements in microalbuminuria and blood pressure than glyburide in patients with type 2 diabetes, independently of its effects on glycemic control" Systematic Review Finds More Reasons To Avoid Diabetes Drug Avandia " The pooled data revealed that patients taking rosiglitazone gained up to 11 pounds in body weight and that the chance of developing edema (swelling) doubled. These changes indicate that the drug causes fluid retention, which can lead to shortness of breath and heart failure" |