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Rosiglitazone to Stay on US Market With New Warnings About MI

Posted: Friday, November 23, 2007

The FDA has decided to allow the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) to stay on the market with increased warnings about the risk of cardiovascular events, while further studies are conducted to investigate the issue. A myocardial infarction warning will be added to the black box warning.

An FDA press release, issued last week, states: "At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared with an active control agent. GSK has agreed to conduct the study, and FDA will ensure it is initiated promptly."

The existing boxed warning on the product's labeling will have the following statement added: "A meta-analysis of 42 clinical studies (mean duration six months; 14 237 total patients), most of which compared Avandia with placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14 067 patients), comparing Avandia with some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive." The boxed warning already cautions that rosiglitazone may worsen heart failure, a warning that is also on the labeling for pioglitazone (Actos, Takeda Pharmaceuticals).

The Avandia label also has been updated to add that the drug is not recommended--although not contraindicated--for use with patients who are taking insulin or nitrates.

The FDA notes that, to date, no oral antidiabetes drug has been conclusively shown to reduce cardiovascular risk, and it will therefore also be requesting that labeling of all approved oral antidiabetes drugs contain language describing the lack of such data.

The agency says that people with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their healthcare provider about the revised warning for rosiglitazone as they evaluate treatment options. It also advises healthcare providers to closely monitor rosiglitazone patients for cardiovascular risks.

The Canadian regulatory authorities have also updated the labeling for rosiglitazone but have used stronger language, stating that "rosiglitazone is no longer approved for use alone or in combination with a sulfonylurea drug to treat type 2 diabetes, except when metformin use is contraindicated or not tolerated."

The updated warnings for rosiglitazone follow recommendations made at a US FDA advisory committee meeting in July that the drug should stay on the market with extra warnings, pending a review of additional data. The advisory meeting was called to discuss a meta-analysis by Nissen and Wolski published in the New England Journal of Medicine in May that suggested an increase in cardiovascular events with rosiglitazone and several other subsequent analyses of cardiovascular risk with the drug.

Source: Diabetes In Control