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Friday, November 16, 2007

Avandia stays on market with increased boxed warning while safety assessed

The US Food and Drug Administration (FDA) has asked the manufacturer of diabetes type 2 drug Avandia (rosiglitazone maleate) to carry out a new long term study to assess the cardiovascular risk of the drug. In the meantime it will stay on the market but carry a higher level of boxed warning about potential increased risk of heart attacks, said the agency in a statement on 14th November.

The FDA said doctors should monitor patients who take Avandia for any potential cardiovascular risks, and people with type 2 diabetes who are at higher risk of heart attack or who have underlying heart disease should make sure the new health warning is considered when they talk to their health care provider about available treatments.

Dr. Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research at the FDA said the agency had:

"Moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings."

"FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines," she added.

Avandia (rosiglitazone maleate) is made by global pharmaceutical giant GlaxoSmithKline (GSK), which in the US is headquartered in Philadelphia, Pennsylvania. The drug has been prescribed to more than 7 million people over the last 7 years to help them control blood sugar.

The FDA approved the drug in 1999 as an adjunct to diet and exercise, either on its own or in combination with other oral anti-diabetes drugs, metformin and sulfonylureas.

Over the last 12 months the FDA has been reviewing several studies showing conflicting results about the side effects of Avandia, such as the risk of chest pain, heart attacks, deaths related to heart problems and deaths from any cause.

The agency has concluded that the evidence is not sufficient to show conclusively that Avandia is any riskier than some other oral drugs for treating type 2 diabetes and has therefore asked GSK to set up a new long term study to assess the cardiovascular risks of Avandia. GSK has agreed to carry out such a study and said it will do so promptly.

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