FDA panel overwhelmingly rejects Acusphere ultrasound heart contrast agent
In a 16-1 vote, the FDA panel of outside advisers said there was not consistent data to prove Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension worked, noting concern about potential side effects, including low blood pressure and fainting spells.
“There is an issue with using this contrast agent and I'm bothered by it,” John Flack, professor of medicine at Wayne State University in Detroit, told the Associated Press. “It's not benign and clearly there would have to be limits and restrictions on who it's given to.”
On Monday, federal regulators expressed similar misgivings about the ultrasound heart-imaging agent, Imagify, and deemed it inappropriate for the product's proposed clinical use.
Clinical studies with Acusphere suggest Imagify may result in acute inflammation and abnormally low blood pressure, according to FDA briefing documents posted Monday. The agency said that 17 patients who were administered Imagify during clinical studies experienced adverse events that were serious enough to cause them to permanently stop taking the product. Such adverse events include vertigo and hypertension.
The advisory committee's recommendations on Wednesday, while not binding, will be considered by the FDA in its review of Imagify’s new drug application. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act is Feb. 28, 2009.