Warning on heart test drug widened

Bristol-Myers Squibb Co. strengthened the warning on its drug Definity, used to enhance heart images from ultrasound scans, after a U.S. inquiry into the medicine’s safety.

The new prescribing information, highlighted in a black box on the package insert and warning of the risk of “serious cardiopulmonary reactions,” was posted Thursday on the Food and Drug Administration’s website. The black box represents the agency’s most serious safety caution.

The FDA said Monday that regulators would be alerting healthcare professionals of serious risks and new safety guidelines in using the agents Definity and Optison before echocardiography, a form of ultrasound used to diagnose heart ailments.

Bristol-Myers, which makes Definity, and General Electric Co., which sells Optison, confirmed that they were discussing package insert revisions with regulators.

“The changes are designed to help ensure the safe and appropriate use of Definity,” Bristol-Myers spokesman Tony Plohoros said. “We believe that Definity still has significant medical value when used properly and in accordance with the label.”

Bristol-Myers will send doctors FDA-approved letters when “the changes are final,” Plohoros said. Sales of Definity were $65 million in the U.S. last year and less than $1 million abroad, Bristol-Myers spokesman Jeffrey Macdonald said.

Definity’s new boxed alert warns that “serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration,” advising that patients be closely monitored and resuscitation equipment be on hand for half an hour after injecting the drug.

Definity, approved by the FDA in 2001, and Optison, allowed since 1997, enhance ultrasound images to help doctors see the heart more clearly. The drugs are a gas enclosed in small capsules of protein or fatty material that make heart borders clearer, letting doctors rule out small clots and identify abnormalities on the heart wall.