Health authorities have issued a critical advisory urging parents and healthcare providers to avoid giving oral antihistamines to children under six years old due to potential severe side effects. This recommendation follows an investigation prompted by the Therapeutic Goods Administration (TGA) into the safety of antihistamines containing promethazine, a common ingredient found in popular brands like Phenergan by Sanofi and other generic equivalents.
Alarming Side Effects Raise Red Flags
The TGA’s investigation revealed that these medications, widely used to manage allergies, hay fever, and nausea, carry significant risks when administered to young children. The reported side effects include hyperactivity, aggression, hallucinations, and cognitive impairments such as reversible intellectual disability.
“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,” the TGA stated in its advisory.
Notably, the Product Information (PI) and Consumer Medicine Information (CMI) for Phenergan have been updated to include these warnings, highlighting the risks of psychiatric and central nervous system side effects.
Intellectual Impacts and Hallucinations: A Deeper Look
For children under six years of age, particularly those receiving high doses, promethazine poses an increased risk of severe cognitive issues. The medication may induce learning difficulties and intellectual disabilities, which, although reversible, are concerning enough to warrant significant caution.
“Sanofi-Aventis Healthcare’s comprehensive review of cumulative safety data in children aged two to five has established a clear causal link between promethazine and adverse psychiatric and central nervous system events,” the TGA report noted. This finding underscores the urgency of reevaluating the widespread use of such medications in younger populations.
Widespread Use for Various Conditions
Promethazine-based medications like Phenergan are often employed to manage conditions such as:
- Allergies and hay fever
- Nausea and vomiting
- Insomnia, as a short-term sedative
While these drugs are generally considered effective for adults and older children, their benefits for younger children are outweighed by the associated risks. Despite their over-the-counter availability as S3 products (requiring pharmacist advice), the need for tighter controls and updated guidelines is increasingly evident.
Delays in Updating All Brands
Currently, there are approximately 50 brands of oral promethazine hydrochloride available on the Australian market. Authorities have acknowledged that updating the safety warnings across all these products will take time, potentially delaying the dissemination of crucial information to consumers.
The TGA is working with manufacturers to expedite the process, but parents and caregivers are urged to consult with pharmacists and healthcare professionals before administering these medications to young children.
Pharmacist Advice: A Key Role in Prevention
Oral promethazine products are classified as S3, meaning they are available over-the-counter but require pharmacist guidance. This classification underscores the importance of informed advice to prevent misuse and mitigate risks. Pharmacists play a critical role in ensuring parents are aware of the updated warnings and alternative treatment options.
Broader Implications for Pediatric Medication Safety
The TGA’s findings and subsequent warnings are part of a broader movement to improve pediatric medication safety. They highlight the need for rigorous evaluations of commonly used drugs and greater public awareness of their potential side effects.
Promethazine’s risks are a stark reminder that medications suitable for adults or older children may not be safe for younger ones. The emphasis on updating product information and educating healthcare providers is a step in the right direction, but the delays in implementation reveal systemic challenges in ensuring timely access to vital safety updates.
What This Means for Parents and Caregivers
For parents, this advisory is a critical reminder to avoid using promethazine-containing medications for children under six. Instead, alternative treatments and preventative measures for managing allergies, hay fever, and other conditions should be explored. Consulting with a pediatrician or trusted healthcare provider is essential for determining safe and effective options.
While promethazine has long been a staple in many households for addressing various ailments, this new guidance underscores the importance of vigilance and informed decision-making when it comes to children’s health.
