FDA slaps black-box label on Definity
The FDA has posted its strictest black-box label for Definity, a Bristol-Myers Squibb cardiac ultrasound contrast agent.
The label now contains the warning: “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration.” The warning instructs doctors to monitor patients during and for 30 minutes after an imaging procedure with Definity is conducted, and to have resuscitation equipment and trained personnel readily available.
In a formal statement, Bristol-Myers said it would notify healthcare professionals about the warnings. "We believe that Definity has significant medical value when used properly and in accordance with the label," the company said.
The label now contains the warning: “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration.” The warning instructs doctors to monitor patients during and for 30 minutes after an imaging procedure with Definity is conducted, and to have resuscitation equipment and trained personnel readily available.
In a formal statement, Bristol-Myers said it would notify healthcare professionals about the warnings. "We believe that Definity has significant medical value when used properly and in accordance with the label," the company said.