WASHINGTON (Reuters) - U.S. regulators will soon alert doctors about reports of deaths and serious reactions following the use of certain imaging agents to help diagnose heart problems, Food and Drug Administration officials said on Monday.
The contrast agents, Bristol-Myers Squibb Co’s Definity and General Electric Co’s Optison, are injected into some patients’ veins before doctors view the heart via an ultrasound procedure known as echocardiography.
The FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were injected with either of the products, FDA spokeswoman Karen Riley said.
“The agency will soon be issuing information to health care professionals to alert them to these serious risks and to provide guidance regarding the safe use of this contrast agent,” Riley said.
The FDA also has asked the manufacturers to update the product labels and the companies have agreed, Riley said.
The Wall Street Journal, which first reported the FDA plans, quoted unnamed sources saying the products were expected to carry a “black box” warning, the strongest type for medical products. Riley said she could not say whether the FDA had requested a black box for the information.
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.
The products are made from gases enclosed in tiny capsules of protein or fatty material. They can help doctors visualize the borders of the heart more clearly and identify abnormalities.
Millions of people have echocardiograms each year, but only a small group of them receive Definity or Optison, FDA spokeswoman Julie Zawisza said.
Bristol-Myers spokesman Tony Plohoros said the company was in discussions with the FDA about label revisions for Definity “and will communicate them as soon as they are final.” The product’s 2006 sales were about $65 million.
GE Healthcare also is talking with the FDA about changing the label for Optison, spokesman Brian McKaig said.
“To date, more than 1 million doses of Optison have been given and very few adverse reactions have been reported,” he said.
Reporting by Lisa Richwine, additional reporting by Bill Berkrot in New York and Scott Malone in Boston