Although the information was already included on the label, the company has made the decision to add the black box to make the warning more visible to patients and doctors. Bristol-Myers said that the label change was made due to “surveillance of adverse effects,” although would not confirm specifics.
Coumadin, which is sold in generic form under the name wafarin sodium, thins the blood and is used to help prevent blood clots forming in patients at risk of heart attacks. However, patients with too much of the drug in their system can bleed heavily from a cut or internal injury.
Bristol-Myers said that the revision had been made after consultation with the FDA, but would not say if the regulators had requested the label change. Bristol-Myers reported Coumadin sales of $110 million during the first half of 2006.