FDA to add black box warning on ultrasound contrast agents
|Source: Medison |
The agency said it "has been investigating reports of deaths and serious cardiopulmonary reactions" in patients. The FDA will alert healthcare professionals about "these serious risks and to provide guidance regarding the safe use" of the drugs, according to an agency spokeswoman.
The WSJ reported that the warning about the drugs could come this week.
The principal drug which is expected to receive additional warnings is Definity, made by Bristol-Myers Squibb, as well as Optison from GE Healthcare, WSJ said. The agency also asked manufacturers to update their product labeling, which they have agreed to do, the FDA spokeswoman said.
"We are in discussions with FDA about label revisions for Definity Vial for injectable suspension and will communicate them as soon as they are final. We are fully committed to assuring timely dissemination of safety information about our products," a spokesman from Bristol-Myers Squibb told Cardiovascular Business News.
This federal action will cause the affected drugs to carry a black-box warning that would tell doctors not to use the contrast agents in patients with unstable angina, acute heart attacks and unstable cardiopulmonary disease, FDA representatives told The WSJ.