FDA Warns of Serious Side Effects of Heart Imaging Drugs
Despite strong warnings to physicians, the FDA says that drugs injected into patients to improve medical images of the heart are still linked to serious side effects and some deaths.
Since October, the FDA has received four reports that patients died after receiving injections of Definity, including a congestive heart failure patient who died within five minutes of the injection. Definity was marketed by Bristol-Myers Squibb Co. until December, when it was sold to Lantheum Medical Imaging.
General Electric markets a similar drug called Optison. The FDA says it has received fewer reports of safety problems with Optison because the drug was not sold between 2005 and 2007.
The drugs are known as contrast imaging agents and are used in echocardiograms, an ultrasound procedure that shows how the blood moves through the heart. The drugs contain tiny gas bubbles that help doctors see small clots and other potential heart problems.
The FDA mandated a black box warning, the most serious possible warning it can require, for Definity in October of 2007, and for Optison in June, 2008.
