Diabetic Drugs including Avandia will Carry Stronger Heart Failure Warning
The Food and Drug Administration announced Tuesday August 14th that Avandia will now have a strong "black box" warning on its label, advising an increased risk of heart failure for users. The “black box” warning is the FDA’s strongest label warning. After reviewing post-marketing reports, the FDA decided that an updated label was needed for the entire class of anti-diabetic drugs. These include Avandia, Actos, Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). The new warning tells doctors to watch patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain; shortness of breath, and edema (swelling) after starting drug therapy. The warning also says that these drugs should not be used by people with serious or severe heart failure with "limits on their activity and who are comfortable only at rest or who are confined to bed or a chair," the agency added.
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