FDA Insists On Box Warning For Promethazine

Law360, New York (September 16, 2009, 3:14 PM EDT) -- The U.S. Food and Drug Administration has ordered makers of promethazine — which Wyeth Pharmaceuticals Inc. once sold under the brand name Phenergan — to attach a boxed warning to the injectable form of the anti-nausea medication, concerned over the serious tissue injury it can cause if administered incorrectly.

On Wednesday, the agency revealed the new warning requirements to the health care community, detailing the risks connected to the sedative.

“Promethazine should neither be administered into an artery nor administered under the skin because of the...
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