FDA backs off warnings on ultrasound imaging drugs.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has eased restrictions on drugs used to enhance ultrasound images of the heart, "The Wall Street Journal" noted May 14. Citing "serious cardiopulmonary reactions" and deaths, the agency slapped a black-box warning last fall on Definity, formerly sold by Bristol-Myers Squibb, and Optison, sold by GE. The warning said the drugs, known as contrast agents, shouldn't be given to acutely ill patients, including those with unstable congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. or acute coronary syndromes. While the agents still carry a warning, the ban on giving them to acutely ill patients has been lifted. That's a big deal because those are precisely the patients who are typically candidates for the drugs, William Zoghbi, president-elect of the American Society of Echocardiography The American Society of Echocardiography (ASE) is a professional organization of physicians, cardiac sonographers, nurses and scientists involved in echocardiography, the use of ultrasound to image the heart and vascular system. , told The Journal. The restrictions meant doctors used alternative methods--including angiograms and an ultrasound technique that involves going in through the patient's throat--that come with their own risks. "We really applaud FDA on their decision to revise the labeling of the contrast agents," Zoghbi said of the news. Zoghbi, who runs the Cardiovascular Imaging Institute at the Methodist DeBakey Heart Center in Texas and has received grants from Bristol in the past, said a number of recent analyses suggested that the risk profile of the agents is low. This study, published by the "Journal of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. " in March, looked at more than 18,000 patients and concluded that Definity doesn't raise the risk of death compared with ultrasound performed without a contrast agent. A research letter published last week in JAMA JAMA abbr. Journal of the American Medical Association looked at 15,000 patients who received the agents and found a "relatively low rate of adverse events" associated with the use of the agents. Earlier this year, Bristol-Myers Squibb spun off its imaging unit to a stand-alone company stand-alone company An independent operating firm. For example, a large diversified firm may consider spinning off a subsidiary because, as a stand-alone company, the subsidiary would command a higher price-earnings ratio than the parent. called Lantheus, which reported the easing of the restrictions. The revision also loosens restrictions on monitoring patients who receive the agents. While the initial warning called for monitoring all patients for 30 minutes after they receive the agents, the new warning says only patients with pulmonary hypertension Pulmonary Hypertension Definition Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right or unstable cardiopulmonary conditions need to be monitored. |
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