Thursday, October 11, 2007

Ultrasound Imaging Drug Gets Black-Box Warning

Ultrasound Imaging Drug Gets Black-Box Warning

October 11, 2007

Posted by Jacob Goldstein

The FDA posted a black-box warning added to Definity, a Bristol-Myers Squibb drug used in conjunction with ultrasound imaging to diagnose heart problems, Dow Jones Newswires reports.

The Health Blog reported on Sunday that the agency has been investigating reports of deaths and serious side effects associated with the drug, and that the warning was imminent.

The warning says: “Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY administration.” It also says patients should be assessed for risk factors that make the drug unsafe, and patients who do receive the drug should be monitored for 30 minutes. The warning ends with an imperative: “Always have resuscitation equipment and trained personnel readily available.”

The drug is also contraindicated for patients with worsening or clinically unstable congestive heart failure and acute myocardial infarction or acute coronary syndromes.

Most echocardiograms are performed without the drug, but doctors sometimes use it when a first ultrasound is inconclusive or in difficult cases.

The stiffer warnings are expected to reduce the use of Definity, several cardiologists told the Health Blog.

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