Bubbles are Back!

A change in the labeling of Definity and Optison is the direct result of concerted efforts by the echocardiology community.

Chalk one up for the good guys! In a rare move, the United States Food and Drug Administration (FDA) has agreed to relax its warning about the possible risks of the two commercially available ultrasound contrast agents, Definity and Optison. In October, 2007 the FDA required the agents to carry a "Black Box Warning" which placed significant restrictions on the use of the agents. Many members of the ultrasound community, particularly cardiologists, questioned the validity of the FDA's decision and felt that the restrictions were not warranted.

Thus, a concerted movement was initiated to objectively assess the safety of contrast. One study, which was presented at this year's meeting of the American College of Cardiology, compared the outcomes of patients who received contrast-enhanced echocardiography studies to patients who did not need to receive contrast. Of the nearly 18,000 individuals who received contrast injections, none experienced an adverse event within 30 minutes. Another compelling report was published in the March issue of the Journal of the American College of Cardiology: "Acute Mortality in Hospitalized Patients Undergoing Echocardiography With and Without an Ultrasound Contrast Agent".

Although the product's package inserts will still have black box warnings, the FDA has eliminated a ban on giving the agents to acutely ill patients, such as those with congestive heart failure (many of which are the very patients that need contrast-echocardiography studies the most). The Feds also changed the requirements for monitoring patients that receive contrast. The previous warning had called for monitoring all patients for 30 minutes after they received contrast, but the new warning only requires monitoring of patients with pulmonary hypertension or unstable cardiopulmonary disease.

The cardiology community should be applauded for their successful efforts to convince the FDA to relax its restrictions. Furthermore, the FDA should be praised for its willingness to right a wrong. Both of these actions will now allow cardiology professionals to resume performing contrast-echocardiograms and enhance (pun intended) the care of cardiac patients.

Lantheus Medical Imaging is the distributor of Definity. Read more about the FDA's labeling requirement here: Lantheus Medical Imaging, Inc.,