The FDA Issues Alert on Phernergan

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. FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables. Cases of respiratory depression including fatalities have been reported with use of promethazine HCl in children less than two years of age. Caution should also be exercised when administering promethazine HCl in any form to pediatric patients two years of age and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings. One manufacturer of suppositories and tablets has notified healthcare professionals of the changed label. The FDA is issuing this safety alert to make sure that healthcare professionals, other caregivers, and patients realize that the warnings apply to promethazine HCl syrups as well.