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