TGA issues urgent safety alert for Phenergan

Australia’s medicines watchdog says parents should immediately stop giving a popular medicine to kids under the age of six, warning of potential ‘psychiatric’ side effects.

Australia’s medicines watchdog has issued an urgent safety alert for Phenergan, advising parents to immediately stop giving the popular hay fever and nausea medicine to kids under the age of six.

The Therapeutic Good Administration issued the alert on Tuesday, saying the oral antihistamine promethazine hydrochloride, which is sold as Phenergan and other generic brands, could produce psychiatric and central nervous system side effects in children.

Phenergan is used to treat a range of conditions including allergies, hayfever and nausea, as well as for short-term sedation, the TGA said.

The TGA has warned parents to immediately stop giving Phenergan to kids under the age of six. Picture: Supplied

“The pharmaceutical company Sanofi-Aventis Healthcare requested the latest updates to advice in the Product Information, Consumer Medicine Information and product label for Phenergan, following an internal investigation,” the watchdog said.

“This was prompted by a TGA investigation and advice from our Advisory Committee on Medicines.

“The PI and CMI documents have been updated to include the risks of psychiatric and central nervous system side effects in children under six, including hyperactivity, aggression and hallucination.

“When high doses are given, these children may also experience difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability.”

The medicine is currently available to patients over-the-counter on advice from pharmacists.

“There are almost 50 other brands of oral promethazine hydrochloride on the Australian market and these sponsors will also be required to update their PI and CMI documents and product labelling,” the TGA added.

The TGA said health professional should be alert to the updated advice and counsel parents and carers who may intend to give Phenergan or another oral promethazine product to a child under six years of age.

“We expect there will be a time lag before all products available in pharmacies will have updated package labelling,” the TGA added.

“In the interim, the updated advice to not use oral promethazine medicines in children under the age of six years applies across all products.”

Originally published as TGA issues urgent safety alert for Phenergan