Health authorities have issued a critical advisory for parents and caregivers, urging them to avoid giving oral antihistamines containing promethazine to children under six years old. The warning from the Therapeutic Goods Administration (TGA) follows an investigation that uncovered risks of severe side effects, prompting updates to safety information for popular brands like Phenergan. This move highlights significant safety concerns over medications commonly used for allergies and colds in young children.
Alarming Side Effects Prompt Official Warning
The TGA’s investigation was launched after reports of serious adverse reactions in young children. These side effects are not minor and include alarming neurological and psychiatric issues.
The reported side effects include hyperactivity, aggression, hallucinations, and cognitive impairments such as reversible intellectual disability. This prompted the TGA to state that the risks associated with these drugs far outweigh their benefits for this age group.
In a direct statement, the TGA noted, “Promethazine can cause serious harm or even death in young children, and there is limited evidence to support its effectiveness in treating common symptoms like cough, cold, and flu.”
Cognitive and Psychiatric Risks Highlighted
The potential for intellectual harm is one of the most concerning findings. For children under six, especially when given high doses, promethazine can lead to severe cognitive problems that affect their development.
The medication may induce learning difficulties and intellectual disabilities. While these conditions are reported to be reversible once the drug is stopped, their occurrence is a major red flag for health regulators.
A comprehensive review by Sanofi-Aventis Healthcare, the manufacturer of Phenergan, confirmed these dangers. The TGA report stated that the review established a “clear causal link between promethazine and adverse psychiatric and central nervous system events” in children aged two to five.
Why are These Medications so Common?
Promethazine-based products have long been a go-to solution in many households for a variety of common ailments. Their over-the-counter availability has made them easily accessible to parents seeking quick relief for their children’s symptoms.
These medications are frequently used to manage conditions such as:
- Allergies and hay fever
- Nausea and vomiting
- Insomnia, due to its sedative effects
Despite being classified as S3 products, which require a pharmacist’s advice before purchase, their widespread use continues. This new advisory underscores the critical role pharmacists play in guiding parents toward safer alternatives for young children.
Delays in Updating Warnings Across all Brands
A significant challenge for regulators is ensuring this new safety information reaches all consumers promptly. There are approximately 50 different brands of oral promethazine hydrochloride available on the Australian market.
Authorities have acknowledged that updating the safety warnings across all of these products will take time. This potential delay means that some products on pharmacy shelves may not yet carry the updated, more explicit warnings.
The TGA is working with all manufacturers to speed up the process. However, the responsibility currently falls on parents and healthcare providers to be aware of the new guidance and to exercise caution.
Guidance for Parents and Caregivers
This advisory serves as a crucial call to action for anyone caring for young children. The primary message is to immediately stop using promethazine-containing medications for any child under the age of six.
Parents should explore alternative treatments and preventative measures for managing allergies, hay fever, and travel sickness. Consulting with a pediatrician or a trusted pharmacist is essential to find safe and effective options tailored to a child’s needs.
While promethazine may remain a useful medication for adults and older children, this new guidance makes it clear that its risk profile is unacceptable for the youngest members of the population. Vigilance and informed decision-making are key to protecting children’s health.
