The federal government is planning on requiring warnings for certain contrast agents used with ultrasound technology. These contrast agents are used to improve diagnoses of heart problems in patients evaluated with ultrasound imaging equipment.
The contrast agents are sold under the brand name Definity, by Bristol-Myers Squibb, and Optison, of General Electric. Physicians inject the imaging agents into patients’ veins before viewing the heart during an echocardiogram. The FDA has received several reports of deaths and heart attacks in patients using the imaging agents.
According to the WSJ who broke the story, a Bristol-Myers spokesman confirmed the company is in discussions with the FDA about revising the instructions for use for Definity. He declined to characterize the changes being discussed and said the company “will communicate them as soon as they are final.” Common side effects from Definity include headache, back or kidney pain and flushing.
The FDA will require black box warnings on these types of drugs, which are the most severe warnings indicated by the FDA to doctors for patients. Patients with unstable angina, a history of acute heart attacks, and cardiopulmonary disease are warned to avoid ultrasound contrast agents.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.
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