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The U.S. Food and Drug Administration (FDA) announced today that the controversial diabetes drug from GlaxoSmithKline, Avandia, will now carry a "black box" warning on its label, advising patients and doctors that use of Avandia presents an increased risk of heart failure.
All Drugs in the Class to Get Same Warning
Dr. Steven Galson, director of the FDA Center for Drug Evaluation and Research, said "This new boxed warning addresses the FDA's concerns that, despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure." He was referring to Avandia and competing drugs that make up the thiazolidinedione class of antidiabetes drugs, including Actos, Avandaryl, Avandamet, and Duetact. All of these drugs' labels will be changed to contain the black box warning about increased risk of heart failure.
Although Previous Warning Existed
GlaxoSmithKline's president, Chris Viebacher, pointed out that Avandia's label included a warning about cardiac problems when it was first released to the market. "Physicians are pretty much aware that Avandia can increase, in some cases, a fluid retention that can cause an additional strain on the heart. So people with congestive heart failure can have some exacerbation of that. But really, this warning has existed," he said.
Monitoring Patients for Heart Failure Signs
The new black box warning advises physicians to closely monitor patients for the symptoms and signs of heart failure after treatment is begun, including shortness of breath, rapid weight gain, and swelling. The warning also contends that these drugs shouldn't be administered to patients with a serious heart failure risk or with "limits on their activity and who are comfortable only at rest or who are confined to bed or a chair."
In July 2007, two FDA advisory panels concluded that Avandia increases the risk of heart problems, but they recommended that the drug remain available to diabetic patients. The panels also advised that a more severe warning about heart risks be added to Avandia's label.
(Source: Forbes online)
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