FDA requires strong amputation warning on injected sedative promethazine
As noted in the San Francisco Chronicle, makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, according to the U.S. Food and Drug Administration.
The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.
The FDA said Wednesday that makers of generic promethazine will have to put a “black box” warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene.
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