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FDA Warns of Ultrasound Drug Risks
A U.S. Food
and Drug Administration spokeswoman said the agency is preparing a warning
about the dangers of drugs used to enhance heart-related diagnoses.
The FDA has
been investigating reports of deaths and serious cardiopulmonary reactions
in patients who took drugs designed to assist in diagnosing heart problems
with ultrasound imaging machines, the Wall Street Journal reported Monday.
The injected
drugs, which include Definity, manufactured by Bristol-Myers Squibb Co.
of New York, and Optison, from General Electric Co., Fairfield, Conn.,
contain microscopic gas-filled spheres that allow for sharper pictures
to be taken of a patient's heart during an echocardiography procedure.
The FDA spokeswoman
said the agency will alert the healthcare industry about "these serious
risks and... provide guidance regarding the safe use" of the drugs.
She said the
drug makers have also agreed to update their labels to reflect the risks.
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