Today it was announced that the FDA will be issuing warnings to doctors about the risks associated with certain imaging agents used to better view the heart in an echocardiograph. The FDA has been investigating reports of serious cardiopulmonary reactions and even deaths associated with the imaging agents. The agents in question are manufactured by Bristol-Myers Squibb Co. under the name Definity, and by General Electric Co., under the name Optison.
These agents are injected into the veins and used to enhance the image, to allow doctors to more easily diagnose heart conditions. The Wall Street Journal first reported the news and claims its sources expect the products to carry a “black box” warning.
Definity had 2006 sales of about $65 million. Optison was recalled by GE Healthcare in November 2005 because of manufacturing problems. The company said last month it hoped to relaunch the product this year in September or October.
With over a million doses of Optison given to date there have been very few reported adverse reactions, but the report of the FDA’s strict action gives me the inclination that the problem may become larger in the near future.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.