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FDA Backs Off Warnings On Ultrasound Imaging Drugs

blogs.wsj.com

The FDA has eased restrictions on drugs used to enhance ultrasound images of the heart.

Citing “serious cardiopulmonary reactions” and deaths, the agency slapped a black-box warning last fall on Definity, formerly sold by Bristol-Myers Squibb, and Optison, sold by GE. The warning said the drugs, known as contrast agents, shouldn’t be given to acutely ill patients, including those with unstable congestive heart failure or acute coronary syndromes.

While the agents still carry a warning, the ban on giving them to acutely ill patients has been lifted. That’s a big deal because those are precisely the patients who are typically candidates for the drugs, William A. Zoghbi, president-elect of the American Society of Echocardiography, told the Health Blog.

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