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A heart disease screening drug has been rejected by experts at the US Food and Drug Administration (FDA), who said its risks outweigh any advantages it has over older products.
Imagify, made by Acusphere, was rejected by the FDA’s panel of heart drug experts by a vote of 16-1, with one abstention.
The vote does not automatically mean that the drug will not win FDA approval, but Acusphere was criticised by the panel for not carrying out further studies into negative side effects reported by patients.
The company has asked the FDA to approve the injectable drug for use in patients undergoing echocardiograms – medical images of the heart. The formula includes tiny particles which improve the clarity of the images.
A number of similar drugs are already on the market, but Acusphere says Imagify is the first that will help medics spot specific blood flow problems.
However, the FDA panel was troubled by side effects reported with the drug, including low blood pressure and fainting spells.
“There is an issue with using this contrast agent and I’m bothered by it,” said John Flack, professor of medicine at Wayne State University. “It’s not benign and clearly there would have to be limits and restrictions on who it’s given to.”
Copyright Press Association 2008
