Ultrasound Drugs to Get Black Box Warnings Following Reports of Serious Injuries and DeathsOct 9, 2007 | Parker Waichman LLP
Ultrasound drugs used to diagnose heart problems could cause serious and sometimes fatal injuries in some patients, and the Food & Drug Administration (FDA) is preparing to warn health care providers about theses risks. In addition, the medications will soon bear new black box warnings about these serious drug side effects.
The drugs at issue are Definity, made by Bristol-Myers Squibb and Optison, made by General Electric. The medications, known as contrast agents, are used in ultrasounds of the heart to enhance images during a procedure called echocardiography. During an echocardiography, the contrast agents are injected into a patient’s veins. The medications contain microscopic gas-filled spheres that sharpen the resulting ultrasound picture. This allows doctors to better diagnose heart defects and malfunctions. According to the FDA, Definity and Optison are only used in a small number of the echocardiography done each year. Generally, the contrast agents are only used when previous ultrasound pictures are inconclusive.
According to an article in the Wall Street Journal, the FDA has received “reports of deaths and serious cardiopulmonary reactions” in patients administered these ultrasound drugs. The Wall Street Journal report says that the FDA will be warning doctors this week of the risks associated with Definity and Optison. The FDA will also provide health care professionals with guidance regarding the safe use of these ultrasound drugs.
The Wall Street Journal is also reporting that both Bristol-Myers Squibb and General Electric have agreed to include black box warnings regarding these risks on the product labels. Black box warnings are the FDA’s most severe type of warning. The Wall Street Journal says that the labels will warn that Definity and Optison are not suitable in patients who have unstable angina, unstable cardiopulmonary disease or a history of acute heart attacks. The labels will reportedly also advise doctors to monitor patients with an electrocardiogram (EKG) for at least a half-hour immediately following an ultrasound that involves either Definity or Optison in order to spot any problems immediately.
The new black box warning will apply to Definity immediately. Optison was recalled in 2005 and has been off the market since due to a manufacturing problem. At that time, the FDA had ordered General Electric to stop selling Optison after an inspection of a third-party factory that manufactured the drug turned up problems with its methods for maintaining sterility. Information regarding Optison on General Electric’s website says that those issues have since been resolved, and that the company plans to reintroduce Optison to the market sometime this fall.