November 19th 2024.
Attention all parents and caregivers! The authorities in charge of our health have recently released a warning against giving the oral antihistamine promethazine hydrochloride to children under the age of six. This medication, commonly known as Phenergan and manufactured by Sanofi, is often used to treat allergies and sleep troubles in adults, as well as a sedative for children over six years old. However, new scientific evidence has shown potential risks for younger children, leading officials to restrict its use in this age group.
According to a review conducted by Sanofi-Aventis Healthcare, there is enough evidence to suggest a link between promethazine and safety concerns in children aged two to five. Specifically, there have been reports of psychiatric and central nervous system events. This is why the Therapeutic Goods Administration has made the decision to limit the use of this medication in children under six years old. Side effects that may occur in this age group include hyperactivity, aggression, and hallucination.
In rare cases where high doses are given, children may also experience difficulties in learning and understanding. This can include temporary cognitive deficits and even intellectual disability. It's important to note that this applies to almost 50 other brands of promethazine-containing products, not just Phenergan. The labels on these products will need to be updated to reflect these safety concerns.
In the meantime, if you have a child under six years old who needs relief from allergies or sleep troubles, it's best to seek alternative products. These oral promethazine products are currently available as S3 products, which means they can be purchased over-the-counter with the advice of a pharmacist. However, the TGA has stated that it may take some time for the updated package labels to be reflected on all products in pharmacies. As always, the health and well-being of our children is of utmost importance, so it's crucial to be cautious and informed when it comes to their medications.
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