Ultrasound contrast problems lead to new FDA warning
According to the Wall Street Journal, the FDA is planning to issue a warning this week about ultrasound contrast problems which could lead to serious and potentially fatal reactions. The contrast agents, which are used to enhance the diagnosis of heart problems, are expected to receive a “black box” warning, which is the most serious warning the federal regulators can place on a prescription product.
The Journal article indicates that the FDA has been investigating reports of serious cardopulmonary reactions and deaths associated with the injections given before some ultrasound exams. The “black box” warning is expected to indicate that the contrast should not be used in those with unstable angina, acute heart attacks and unstable cardiopulmonary disease. Physicians will also be asked to monitor their patients’ heartbeats for a half-hour after the ultrasound to watch for signs of heartbeat problems.
Ultrasound contrast agents are sometimes injected into an individual’s vein before a heart exam, known as an echocardiography. While most echocardiograms are done without use of the contrast agents, they may be required to sharpen pictures of the heart and help doctors interpreting the images to diagnose defects and malfunctions of heart.
The two drugs expected to receive new warnings are Definity, manufactured by Bristol-Myers Squibb Co., and Optison, made by General Electric Company. Definity generated sales of approximately $65 million in 2006. Optiscan has been off the market since 2005 due to manufacturing problems, but GE has previously indicated they plan to resume selling the drug in the near future.
Earlier this year, the FDA announced a “black box” warning which was added to another type of contrast agent used during MRI (magnetic resonance imaging) and MRA (magnetic resonance angiogram) exams. The gadolinium-based contrast agents, which are different from the ultrasound contrasts, have been associated with the development of a rare, but debilitating condition, known as nephrogenic systemic fibrosis, among those with kidney problems.
Information and research regarding the ultrasound contrast problems are being reviewed by the lawyers at Saiontz & Kirk, P.A. If you, a friend or family member experienced problems following an ultrasound, request a free consultation.
