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Wednesday, August 15, 2007

FDA Announces Boxed Warnings on All Thiazolidinediones

FDA Announces Boxed Warnings on All Thiazolidinediones


The entire class of thiazolidinedione drugs used to treat type 2 diabetes must carry boxed warnings about the drugs' ability to cause or worsen heart failure, the FDA announced late yesterday.

The affected drugs are Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride).

The action addresses the FDA's worry 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," says the agency's chief of drug evaluation and research.

FDA announcement (Free)
Rosiglitazone alert (Free)
Pioglitazone alert (Free)

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