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Health Agencies Update
February 23, 2005

Promethazine Warning

JAMA. 2005;293(8):921. doi:10.1001/jama.293.8.921-c

The Food and Drug Administration is requiring the addition of a black box warning to the labeling for promethazine hydrochloride, a drug with antihistamine,antiemetic, and sedative properties. It is commonly prescribed for nausea and vomiting in children (http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm).

The black box warning cautions that the drug should not be used in patients younger than age 2 years because of the potential for fatal respiratory depression. Postmarketing reports have noted cases of respiratory depression, including fatalities, in such children. The warning also recommends exercising caution when administering promethazine hydrochloride to children aged 2 years or older and avoiding concomitant administration of other drugs with respiratory depressant effects.

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