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News Articles >> FDA now flooded with reports of Heart Fa..
FDA now flooded with reports of Heart Failures linked to Avandia
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| August 15, 2007. By Brenda Frohloff |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: The Food and Drug Administration (FDA) has been bombarded with reports of heart attacks, heart failure, and heart-related hospitalizations in diabetics taking Avandia since May 21, the day the New England Journal of Medicine published Dr. Steven Nissen's startling analysis of the drug on the Internet.
"The Associated Press obtained the information from the FDA through a Freedom of Information Act Request. The FDA released the numbers of reports of heart failure in users of Avandia and Avandamet both before and after the analysis was published. In the 35 days before May 21, the FDA received reports of 5 heart attacks, 11 hospitalizations, and 11 deaths allegedly linked to these drugs, but that in the first 35 days after May 21, these numbers jumped to 90 heart attacks, 126 hospitalizations and 38 deaths, respectively.
What these figures mean is that doctors had not been told before May 21 about the dark side of Avandia—the possible increased risk of heart failure. After May 21, they were able to put two and two together.
Critics also say that this big jump in reports of Avandia and heart failure proves there is a big flaw in the FDA's information gathering system. After it has approved a drug, the FDA relies on voluntary reporting to learn of any adverse reactions or problems it causes. And if a doctor is unaware of the possibility of a given adverse reaction to a drug, that doctor will not likely report it as a problem with the drug. In the absence of information from the FDA, the doctor's only information about a given drug is likely only that supplied so willingly by the manufacturer.
Dr. Nissen first publicly raised his concerns about Avandia in a letter he wrote to the Lancet last December. In it he reported on the result of a 5000-patient clinical trial called Dream in which GlaxoSmithKline tested Avandia as a preventer of diabetes. Dream showed that Avandia did help in preventing the disease, but it also showed that, when compared to the control group, the Avandia group had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardio-vascular related problems. Nissen went on to say that this result raised "serious questions about the safety of this agent".
Yet the FDA and Avandia's manufacturer, GlaxoSmithKline, allegedly knew about this link long before Nissen's report was published. How many patients taking Avandia suffered heart failure, or died, because the FDA and Glaxo effectively kept them and their doctors in the dark?
Because these patients (or their estates) have started filing lawsuits against the manufacturer, that question will be answered in court.
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