Originally published November 5 2008
Serious Complications and Death Linked to Heart Imaging Drugs
by David Gutierrez, staff writer
(NaturalNews) The FDA has said it is still concerned that certain heart imaging dyes may lead to serious side effects and even deaths.
"FDA remains concerned about the accumulating safety data pertaining to marketed ultrasound contrast agents, and the labels for these products that continue to contain a boxed warning that highlights the risk for serious cardiopulmonary reactions," FDA officials said.
The agents in question are used during electrocardiograms, in which doctors use ultrasound to take a three-dimensional, real-time picture of the heart as a diagnostic tool. When a doctor feels it is necessary, chemicals known as contrast agents are injected into the blood to increase the contrast of the picture and improve its detail.
The FDA has expressed concern over GE Healthcare's contrast agent Optison and Lantheus Medical Imaging's similar product Definity. In October 2007, the agency issued a warning that the products had been linked to seven deaths and 200 other cases of serious side effects, including breathing trouble, seizures and a cessation of heartbeat. Since then, four more deaths have occurred in people given electrocardiograms with Definity.
According to GE Healthcare, Optison was voluntarily withdrawn from the market even before the FDA warning due to unrelated problems with a contract manufacturer. The product was reintroduced in 2007, however.
When doctors objected that the information gained from the contrast agents could help save lives, the FDA scaled back its October warning. Now the agency has convened a panel of independent experts to investigate the products - although that panel will not make any regulatory recommendations. The FDA is also reviewing information on other contrast agents.
Manufacturers have asked the FDA to approve the contrast agents for other uses, such as liver exams. The agency says that it wants to comprehensively review the dangers of the agents before deciding whether to extend approval to new uses.
Sources for this story include: www.reuters.com.
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