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Physicians Will Be Warned About Hazards With Agents Used to Enhance the Diagnosis of Heart Problems Using Ultrasound Imaging

by Joan Trombetti, Writer | October 17, 2007
Definity, (Bristol-Myers
Squibb Co, NY) and
Optison (General Electric
Co, Fairfield, CT).
The Food and Drug Administration will soon alert health care workers about the danger of giving drugs used in helping to diagnose heart conditions with ultrasound imaging. The main drugs in question are Definity, (Bristol-Myers Squibb Co.) and Optison (General Electric Co.). The drugs contain microscopic gas-filled spheres and are injected into the veins of patients before the heart is examined with ultrasound. The gas leaves the body after a few minutes. The drugs (called contrast agents) make the pictures of the heart clearer during echocardiography. This helps physicians diagnose heart disease and malfunctions. Unfortunately, the FDA has found through investigations that there have been reports of deaths and serious cardiopulmonary reactions in some patients.

The manufacturers have also agreed to update their product labeling to carry a "black-box" warning, the sternest cautionary note available, that tells doctors not to use the medicines in patients with unstable angina, acute heart attacks and unstable cardiopulmonary disease. The labels will also instruct physicians to monitor patients' heartbeats for trouble signs with an electrocardiogram, or ECG, for a half-hour after the ultrasound exam is finished.