Avandia gets Black-Box Warning
November 15, 2007
The FDA has ruled that the diabetes drug Avandia must now carry a “black box” label warning that the drug may increase a person’s risk of heart attack and angina.
The action follows the recommendation of the FDA’s outside advisory panel. The panel last July voted 22-1 against removing the drug from the market, but said the drug’s label should carry a stronger warning.
The FDA decision against an Avandia ban came after a split vote from its own internal safety review board.
In August, the FDA announced that all thiazolidinedione diabetes drugs — the class of drugs including Avandia, Actos, Avandaryl, Avandamet, and Duetact — would carry a black-box warning that the drugs may cause or worsen heart failure in some patients.
Avandia will now carry an additional black-box warning. The warning alerts patients and doctors to troubling but inconclusive evidence that the drug may increase a patient’s risk of heart attack and angina.
Avandia’s new label also notes that the drug is not recommended — but not contraindicated — for patients already taking insulin or nitrate drugs.
[Via Web-MD]
Comments
Got something to say?
Powered by WordPress
