The commonly prescribed diabetes drug, Avandia (rosiglitazone), has come under the scrutiny of the Food and Drug Administration (FDA) this week, as a result of a new study published in the New England Journal of Medicine today.According to the study, Avandia (rosiglitazone) may lead to heart attacks and even death from cardiovascular causes. The study comes from the Cleveland Clinic and was actually a compilation of data from 42 different rosiglitazone studies that have already taken place. Rosiglitazone is an oral medication used to treat type 2 diabetes. It is in the thiazolidinedione class of drugs which lowers blood glucose levels by increasing insulin sensitivity in the body.
The conclusion reached in the Cleveland Clinic study was that rosiglitazone increased the risk of heart attack and other fatal cardiovascular events. Researchers recommend that people who take Avandia for type 2 diabetes should discuss the risks of treatment with their doctors and that doctors should seriously weigh the cardiovascular risks of treatment with rosiglitazone before prescribing it. There are many other classes of oral medications that control diabetes well that are not known to cause cardiac problems.
One of the concerns addressed in the study was that people with type 2 diabetes already have cardiac problems as a result of complications from their diabetes. If they are also on Avandia, their risk might be higher for fatal cardiac events.
The press release from the FDA states:
FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.
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