Promethazine Must Carry Warning About Possible Tissue Damage: FDA
September 16, 2009 - 4:23pm
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The antihistamine and anti-nausea drug promethazine must carry a warning that it can cause tissue injuries, including gangrene, if it's administered incorrectly, says the U.S. Food and Drug Administration.
The agency said Tuesday that the drug's label must carry a warning that it should not be administered into an artery or under the skin. The drug should be injected deep into muscle, the Associated Press reported.
A requested label revision would caution doctors who choose to administer promethazine intravenously to limit the concentration and rate of administration of the drug.
Manufacturers must submit the safety label changes to the FDA within 30 days or make a case for why they feel changes aren't needed, the AP reported.
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