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Australia’s medicines watchdog says parents should immediately stop using a popular oral antihistamine, used to treat allergies, hay fever and nausea.

The Therapeutic Good Administration (TGA) has issued a safety alert, warning that promethazine hydrochloride, sold as Phenergan, should not be given to children under six years old.

The TGA said there’s a risk 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’.

Phenergan

Phenergan is used to treat allergies, hay fever and nausea, and is also used for short-term sedation.

“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 explained.

“Oral promethazine products are currently available as S3 products which can be given to patients over-the-counter on advice from pharmacists.

“We expect there will be a time lag before all products available in pharmacies will have updated package labelling. In the interim, the updated advice to not use oral promethazine medicines in children under the age of 6 years applies across all products.”

  • Thank you for this important warning – they should be shared as widely as possible.

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  • Haven’t heard of this brand. We use zyrtec

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  • It really is so very important to share this information with this community and then; hopefully members of this community will in turn share with their networks and extended circles. Thank you MOM for sharing this important information; it really is very important to stay up to date with all warnings.

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  • Why has it taken them so long to realise this should not be given to children under 6 years old? I’d be wary of giving it to children of any age without a doctor’s recommendation. Maybe some of the children who have been diagnosed with hyperactivity and aggression were that way because of the medication and not for any other reason. It would be interesting to find out if the symptoms stop after the medication is ceased.

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  • I saw this warning on the news last night. A little worrying if you have been using it. I don’t think I’d even risk it with over 6 years now. Very scary.

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  • I want to know why any parent would think that such strong medications to such young children. I mean it says that this can be used for short term sedation? Say what? I get that parents are concerned about relieving symptoms, but I’m sure there are much milder alternatives, especially in young children!

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  • i used this three times so far but scared now. The advice for parents to stop giving popular hay fever medication to young children raises concerns about safety. While these medications are commonly used, the warning highlights potential risks or side effects for younger children. Parents should consult with healthcare providers for safer, age-appropriate alternatives to manage symptoms.

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  • I used it once for my daughter who was then probably 4 years old for travel sickness. But to be honest it’s actually strange that this is sold over the counter without a script of the GP. This is absolutely not the case in the Netherlands – where I come from- or other countries in Europe


    • I worked for many years as a psychiatric nurse and know promethazine as a medicine that quite often was used by psychosis. Promethazine is a phenothiazine. It is thought to be antipsychotic in itself ‐ although weakly so compared with others ‐ but has strong antihistamine and moderately potent anticholinergic properties (Figure 2). Promethazine is known to be sedating, which is likely due to its antihistaminic properties.

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  • I’ve never uses this for my children but when I used to work in pharmacy I saw many parents purchase it. Never any judgement because it was usually for a long haul flight. Or genuine allergy. I always felt that you just wouldn’t give it to young ones unless it’s medically very necessary. I can see that some people would just do it because… so it’s a good thing the TGA have stepped in

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  • Thanks for this best Article ever. https://asktotalks.info/thank-you-for-the-tip/

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  • We never used this but I know plenty of people who have or do. Thank you for helping spread this important message.

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  • This is a really valuable and important article and it is great that you are sharing this new advice here for mums to see and read up on. I don’t use this product but i am sure there are plenty of parents out there that do and this article will be very valuable for them.

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  • Really important information, thanks MoM. I’ve heard people joking about giving this to their littles when they were a little rambunctious and the parents wanted some chill time, all as a joke of course. But you never know who might think it’s okay to give to really young kids. Always great when this info is widely available.


    • The thought that it would be potentioally misused by some for this reason is of course quite disturbing. Personally I think this is even more reason why this product should not be sold over the counter. Personally I think a warning is not strong enough, it would really be better when it would become a script only medicine.

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