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 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 mark.