10 | 19 | 2007 Posted By Regan Zambri & Long

FDA Links Heart Imaging Drugs to Serious Risks, Fatalities

The U.S. Food and Drug Administration (FDA) has warned that a type of drug used in heart testing can cause serious cardiopulmonary reactions, and has advised that a Black Box warning should warn against the risk.  Marketed as Definity and Optison, the drugs, classified as micro-bubble ultrasound contrast agents, are used by physicians to get a clearer image of the heart during electrocardiography.  The FDA has warned that these drugs have caused as many as 11 deaths and nearly 200 dangerous adverse reactions, mainly in patients with severe heart conditions.  Adverse reactions typically occur between 1 and 12 hours after administration of the injectable drug.

Definity, manufactured by Briston-Myers Squibb, gained FDA approval in 2001.  Optison, manufactured by General Electric, was approved in 1997.  Both drugs are comprised of a gas enclosed in tiny capsules of protein or fatty material, and they help illuminate the borders of the heart during electrocardiography, alerting physicians to small clots or abnormalities of the heart wall.  FDA officials are recommending that patients be closely monitored, and that resuscitation equipment be kept close at hand for at least 30 minutes after these drugs are used. 

The agency advises that in the interest of safety, prior to a heart imaging test, patients should alert their physician if they:

  • "have a congenital heart defect
  • have a heart or lung condition that has recently gotten worse
  • have ever had a reaction to a drug given to you during an echocardiogram"

 
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

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