The Therapeutic Goods Administration (TGA) has issued a stern warning against administering over-the-counter products containing promethazine to children aged under six. This caution arises from significant concerns over severe side effects, which can manifest as hyperactivity, aggression, hallucinations, and, in more severe cases, respiratory depression—where breathing becomes dangerously slow or shallow, potentially leading to fatal outcomes.

Research indicates that when young children are given high doses of promethazine, they may suffer from learning difficulties and comprehension issues, which can include reversible cognitive deficits and even intellectual disabilities, according to the TGA’s latest advisement.

This recent advisory follows growing international scrutiny, alongside concerns within Australia, regarding the safety of promethazine in pediatric patients. The medication is frequently used for treating various ailments, including seasonal hay fever, allergic reactions, travel-related nausea, and short-term sedation needs.

What is promethazine?

Promethazine is classified as a “first generation” antihistamine, having been available over the counter at Australian pharmacies for many years to address a spectrum of health conditions.

One of the distinguishing features of first generation antihistamines is their ability to cross the blood-brain barrier, directly influencing brain chemistry. This interaction can produce drowsiness and sedation in users, which may be beneficial for adults seeking sleep induction.

We’ve known about this for a while

The potential severe side effects of promethazine in younger children have been acknowledged for an extended period. Advancements in clinical guidance suggest that around two decades ago, the prevailing recommendation in the United States was to refrain from using this drug in children younger than two years old. More recently, in 2022, the Australian Advisory Committee on Medicines proposed raising the age limit to six years. Notably, New Zealand similarly cautioned against the use of promethazine in young children in a warning issued in May of this year.

Data over the last decade shows that the TGA has logged 235 occurrences of severe adverse reactions related to promethazine, affecting both young and older patients. Alarmingly, from these, there were 77 recorded fatalities—including one case involving a child under six.

The side effects reported by both adults and children include:

• 13 cases of accidental overdose leading to 11 fatalities.
• Eight documented instances of hallucinations.
• Seven cases where patients experienced slow or shallow breathing, resulting in four deaths.
• Six instances involving lowered consciousness, which led to five fatalities.

The TGA’s recent safety alert follows an internal review by the manufacturer of Phenergan, Sanofi-Aventis Healthcare, which was initiated after the 2022 advisories from the Advisory Committee on Medicines. In response, the company has updated safety information targeting both consumers and healthcare professionals.

What can you use instead?

In the case of allergies or hay fever affecting young children, it is advised to opt for non-sedating antihistamines like Claratyne (loratadine) or Zyrtec (cetirizine). These alternatives provide effective relief while minimizing the potential for sedation and other alarming side effects associated with promethazine.

For cold or cough symptoms, parents should note that these generally resolve with time, adequate fluid intake, and rest. Saline nasal sprays, ensuring proper hydration, using a humidifier, or elevating your child’s head can effectively relieve nasal congestion related to allergies. However, oral phenylephrine products that claim to relieve nasal congestion should be avoided, as research indicates they are ineffective; nonetheless, nasal spray versions of the medication remain safe for use.

What else can I do?

A pharmacist can guide you in selecting the most suitable treatments for your child’s specific condition and help discern when medical attention is warranted.

If your child experiences alarming side effects from promethazine or any other medication, please reach out to the Poisons Information Centre immediately at 13 11 26. In the event of an emergency in Australia, dial 000.

Understanding the New Warnings on Promethazine for Kids

Ah, promethazine—the over-the-counter wonder drug promising to help with allergies, travel sickness, and, in some unexplained way, possibly inducing a state somewhere between drooling and snoring. But hold onto your hats, parents, because the Therapeutic Goods Administration (TGA) has just swung the cautionary hammer down on this medication for children under six. Serious side effects? You bet! We’re talking hyperactivity, aggression, hallucinations, and, just for a little flair, slow or shallow breathing that could lead to something a bit less than “fun in the sun.”

Now, let’s chew on that for a moment. This is the same medication that’s been crowding family medicine cabinets for decades. The TGA’s not just flipping a coin with this alert—they’ve got empirical evidence. High doses can send young children bouncing off the walls, only to find they’ve forgotten how to operate their own brains, leading to what they charmingly refer to as reversible cognitive deficits or outright intellectual disability. Yikes!

What’s the Deal with Promethazine?

To put it bluntly, promethazine is a “first generation” antihistamine that has been an unwavering companion to parents for years. It’s a medicine that behaves a bit like that one friend at a party who crosses your blood-brain barrier and suddenly—voila!—you’re feeling all drowsy and sedated. Helpful for adults trying to catch some Z’s? Yes! But this medication is more like that dodgy housemate you never invited over to your child’s birthday party. Seriously. It’s been linked to all sorts of nerve-wracking side effects in children.

But Really, We’ve Been Aware for Ages

In the medical world, this isn’t exactly breaking news. The buzz surrounding the dangers of promethazine in young ones dates back over 20 years. The good ol’ US of A warned against using it in kids under two, and just last year, our friends down under decided six was a safer benchmark. They’ve even had some dramatic incidents over the last decade: 235 cases of severe side effects, including 77 tragic deaths that remind us of that “boiling frog” saying. Keep raising the temperature, and eventually, you’re in trouble without anyone noticing.

In summary: side effects in adults and children have included a charming list of threats including accidental overdoses, where 11 lives were tragically cut short, hallucinations, shallow breathing (which sounds like an awful yoga class), and lowered consciousness. Basically, promethazine could offer a wild ride on the roller-coaster of life—or, you know, just slingshot you straight into the emergency room. Delightful!

So, What Can Parents Use Instead?

Now, before you toss your medicine cabinet into the bin and embark on a journey to find the Holy Grail of allergy relief, fear not! There are non-sedating antihistamines like Claratyne (loratadine) and Zyrtec (cetirizine) available. These little champions offer relief without the psychedelic adventure of side effects we’ve just discussed. And for those pesky coughs and colds? Let’s just remember that patience is a virtue! Most of those symptoms improve with time, hydration, and a little bit of TLC.

Some Practical Tips

Here’s where we get practical: saline nasal sprays, humidifiers, and a good head elevation can be your allies in battling congestion. And don’t fall for the trap of oral phenylephrine—evidence says it’s about as effective as a chocolate teapot. Stick with the nasal spray formulations if you must.

And let’s not forget about fever or discomfort—paracetamol remains your best buddy here. So next time your child’s feeling under the weather, resisting the urge to stuff a promethazine tablet down their throat could save you a nightmare of worries.

What Else Can You Do?

If you’re scratching your head and wondering about the right choice for your little one, your local pharmacist is a treasure trove of knowledge. They can guide you in navigating the jungle of medications and help decipher which are safe and when to wave the white flag of surrender—err, when to seek medical attention.

Remember, if any alarming side effects occur from taking promethazine, or really any medicine, don’t hesitate—call the Poisons Information Centre on 13 11 26. And in dire emergencies, you know what to do—dial 000 and get the help you need.