FDA to add black box warning on ultrasound drugs
The U.S. FDA plans to warn physicians about hazards with drugs used to enhance the diagnosis of heart problems using ultrasound imaging, according to The Wall Street Journal (WSJ).
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, said 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 from Bristol-Myers Squibb, as well as Optison from GE Healthcare, according to The WSJ.
"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 for Bristol-Myers Squbb told Health Imaging & IT.
The agency also asked manufacturers to update their product labeling, which they have agreed to do, the FDA spokeswoman said.
This federal action will cause the affected drugs to carry a black-box warning that would tell doctors not to use the medicines in patients with unstable angina, acute heart attacks and unstable cardiopulmonary disease, FDA representatives told The WSJ.
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, said 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 from Bristol-Myers Squibb, as well as Optison from GE Healthcare, according to The WSJ.
"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 for Bristol-Myers Squbb told Health Imaging & IT.
The agency also asked manufacturers to update their product labeling, which they have agreed to do, the FDA spokeswoman said.
This federal action will cause the affected drugs to carry a black-box warning that would tell doctors not to use the medicines in patients with unstable angina, acute heart attacks and unstable cardiopulmonary disease, FDA representatives told The WSJ.