The American Society of Echocardiography (ASE) said it welcomes the U.S. Food and Drug Administration's (FDA) modification of black box warning labels required for the two echocardiography contrast agents that are commercially available in the U.S.
Earlier this month, the FDA said it would allow the two companies with echo contrast agents on the market, Lantheus Medical Imaging of North Billerica, MA, and GE Healthcare of Chalfont St. Giles, U.K., to sell their products with revised labeling information in the black box warning label, rather than the more restrictive warning initially used when the black box requirement was issued last year. Lantheus sells the Definity contrast agent, while GE markets Optison.
The FDA's reversal follows an extensive lobbying campaign by echocardiography experts, who sought to demonstrate that the safety profile of echo contrast agents does not warrant the more restrictive language. The ASE said that it believed the initial black box language was "unnecessarily restrictive" and might prevent clinicians from using the agents in situations where their diagnostic benefits were well established.
According to the ASE, the contraindications and warnings for Definity and Optison have been revised, and the mandate for a 30-minute postinfusion monitoring period has been modified to cover only high-risk patients. The ASE said that it has organized a joint session with FDA officials to cover the changes at its annual conference in Toronto on June 10.
"The new labeling guidelines reasonably address patient safety, while at the same time facilitating the appropriate use of contrast agents to improve the value of the echo examination," the ASE said in a statement dated May 13. "We want to thank our members who worked diligently to collect and communicate the information that ultimately led to the revisions. We also thank the FDA for its open communication and willingness to consider all the available information and, in the end, to act in the best interest of the patients."
Related Reading
Lantheus updates Definity label, May 13, 2008
Ultrasound contrast agents appear safe despite FDA warning, April 1, 2008
Ultrasound contrast advocates take aim at FDA black box warning, January 3, 2008
Definity to carry warning label, October 12, 2007
U.S. FDA to alert doctors about imaging drugs' risks, October 9, 2007
Copyright © 2008 AuntMinnie.com
