FDA to slap black box on ultrasound drugs

Sometimes, seeing clearly is dangerous. Or so says the FDA, which is prepping a warning for doctors who use drugs to help diagnose heart problems using ultrasound imaging. The agency has been investigating reports of deaths and serious cardiac reactions to the drugs, Definity from Bristol-Myers Squibb [1] and Optison from General Electric [2].

Both drugs are used to heighten contrast in ultrasound images so that doctors can see problems more clearly. The manufacturers have agreed to add a black-boxes to the drug labels to warn against their use in certain patients and to call for heart monitoring via ECG during the imaging process. Optison has been off the market since 2005 because of manufacturing problems; GE has said it plans to reintroduce the drug this month.

- read the report [3] from the Wall Street Journal (sub. req.)