Resources for Food and Drug Administration (FDA)

FDA calls for strong warnings on two imaging drugs

www.newsday.com

Citing 11 deaths in patients who received either of two drugs that can enhance heart images in people undergoing echocardiograms, the Food and Drug Administration Friday called for serious black box warnings for both products.

Bristol-Myers Squibb's Definity and General Electric's Optison -- imaging agents regulated as drugs by the FDA -- will both carry black box warnings.

The FDA received reports of 10 deaths in patients who received Definity and one death involving Optison.

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