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Home arrow News arrow Latest arrow Reminder against use of promethazine (phenergan) in children less than two years old

Reminder against use of promethazine (phenergan) in children less than two years old Print E-mail
published 06-05-2006

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Promethazine (phenergan) is commonly used in Africa as an antiemetic, but it carries risks. A new announcement from the US government FDA (Food and Drug Administration) serves to remind us of the dangers of its use in children. "Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years of age because of the potential for fatal respiratory depression. This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables." A short commentary on Medscape adds, "The FDA has received postmarketing reports of serious adverse events, including 7 deaths and 22 cases of respiratory depression, that were associated with use of promethazine in children younger than 2 years."

Besides the contraindication of use under two years of age, there are cautions in using phenergan for older children: "… promethazine should be administered with caution and at the lowest effective dose for pediatric patients aged 2 years and older. Concurrent administration of other drugs with the potential for respiratory depression should also be avoided. … The FDA notes that antiemetics are not recommended for the treatment of uncomplicated vomiting in pediatric patients; use of these agents should be limited to prolonged vomiting of known etiology." (Medscape)

We have seen promethazine toxicity fairly often at Evangel, especially altered level of consciousness and the extrapyramidal side effects such as torticollis (inability to turn the neck) or protruding tongue. These may be misdiagnosed as cerebral malaria, meningitis, tetanus, or even spiritual oppression. To avoid these as much as possible, it is important to stay within the recommended dosing guidelines using the actual or carefully estimated weight of the child, rather than simply using a fixed "child's" dose.

   
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