WASHINGTON – Federal health officials warned parents and doctors Tuesday not to give drugs that contain promethazine hydrochloride to children younger than 2, citing seven cases of death linked to use of the antihistamine.
The Food and Drug Administration said in a safety alert that beyond the deaths, it also has received 22 reports of severe breathing problems associated with use of the allergy drug, all in children younger than 2.
The drug, also known as promethazine HCl, is sold by Wyeth under the brand name Phenergan as well as in various generic versions. The warning covers all forms of the drug, including syrups, suppositories, tablets and injectable liquids.
Parents also should use care in giving the drug to children older than 2, the FDA said.
The labels on all versions of the drug have been updated to reflect the strengthened warnings, the FDA said.
The drug, approved in 1951, is used to treat hay fever, stuffy or runny nose due to allergies and other minor allergies.