U.S. FDA panel urges approval of Eisai sedative
By Lisa Richwine
GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel recommended approval on Wednesday for a proposed sedative from Japan's Eisai Co Ltd (4523.T: Quote, Profile, Research) but urged against use by health-care workers without general anesthesia training.
Eisai has touted the potential use by non-anesthesiologists as a major advantage of the drug, Aquavan, for use in procedures such as colonoscopies.
In an 8-2 vote, the group of outside advisers to the U.S. Food and Drug Administration said they were not convinced Aquavan could be safely given by medical personnel without general anesthesia training.
Members said they were concerned some patients may develop complications that could not be managed by other workers.
"The risk of using it in a less-monitored situation has huge potential downsides. That whole issue needs to be much better understood and studied," said the panel's chairman, John Farrar of the University of Pennsylvania.
Still, the committee voted 6-3 with one abstention to recommend approval of the drug for sedating adults undergoing various diagnostic and therapeutic procedures.
"It's likely this drug will have a role in sedation," said Dr. Nancy Nussmeier, chair of anesthesiology at State University of New York's Upstate Medical University.
The FDA will consider the panel's input before deciding whether to approve the product. The FDA usually follows panel recommendations, and a final decision is expected by July 26. Continued...
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