Manufacturers of certain drugs approved for treating Type 2 diabetes have agreed to add stronger warnings on the risk of heart failure, announced the U.S. Food and Drug Administration (FDA). The information will be included in a “boxed” warning – the FDA’s strongest warning.
The updated warning label will highlight that certain drugs may cause or worsen heart failure in some patients.
The FDA determined an updated label with a boxed warning on the risks of heart failure was required for the thiazolidinedione class of antidabetic drugs after a review of adverse reports. Included in this class are Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). The FDA has requested that the manufacturers of these drugs, GlaxoSmithKline and Takeda, address these concerns.
While reviewing the adverse event reports, the FDA discovered cases of significant weight gain and edema – both warning signs of heart failure. In some reports, continued use was association with poor health outcomes, some including death.
The updated warnings will advise health care officials to carefully observe patients for signs and symptoms of heart failure. The warning will also state that these drugs should not be used by those people who have serious or severe heart failure.
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