Promethazine Products Contraindicated in Children Under 2 Years

Yael Waknine


April 26, 2006

April 26, 2006 -- The US Food and Drug Administration (FDA) is warning healthcare professionals, parents, and caregivers against the use of promethazine HCl in children younger than 2 years due to the risk for fatal respiratory depression, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

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. As a result, all promethazine-containing syrups, tablets, suppositories, and injectables are contraindicated in this population.

Because these adverse events were not directly related to individualized weight-based dosing, 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.

Promethazine-containing products are marketed in the United States as brand name ( Phenergan, made by Wyeth Pharmaceuticals, Inc) and generic formulations. They are indicated for use in treating hypersensitivity reactions and as an antiemetic and/or sedative in various settings.

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.

Because the drug's extrapyramidal effects may be confused with central nervous system signs of undiagnosed primary disease, promethazine should not be used in pediatric patients with signs and symptoms suggestive of Reye's syndrome or other hepatic diseases.

Healthcare professionals are encouraged to report promethazine-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

Related Medscape Alert: Phenergan May Cause Pediatric Respiratory Depression, Death


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