Phenergan is no longer recommended for children under 6 years of age due to the risk of hallucinations. Here’s what you can exploit instead

The Australian Drugs Regulatory Authority has issued an order safety warning over Phenergan and related products containing the antihistamine promethazine.

The Therapeutic Goods Administration has stated that over-the-counter products should not be given to children under six years of age due to concerns about sedate side effects such as hyperactivity, aggression and hallucinations. Breathing may also become tardy or shallow, which can be fatal.

When high doses are administered to teenage children, difficulties in learning and understanding, including reversible cognitive deficit and intellectual disability, may also occur. – said the TGA.

The latest warning follows international and Australian concerns about the drug in teenage children, which is commonly used to treat conditions such as hay fever and allergies, motion sickness and for short-term sedation.

What is promethazine?

Promethazine is a “first generation” antihistamine that has been sold over the counter in Australian pharmacies for decades for a variety of conditions.

Unlike many other drugs, first-generation antihistamines can cross the blood-brain barrier. This means they affect your brain chemistry, making you feel drowsy and sedated.

In adults, this may be useful for sleep. However, in children, these drugs can cause sedate side effects on the nervous system, including those mentioned in this week’s safety alert.

We’ve known about this for some time

We have known about the sedate side effects of promethazine in teenage children for some time.

Advice regarding 20 years ago In the United States, the drug was not recommended for exploit in children under two years of age. In 2022, an Australian Medicines Advisory Committee made its own recommendation to raise the age to six. Novel Zealand released similar warnings and advice in May this year.

Over the last ten years, 235 cases of sedate side effects from promethazine have been reported in both children and adults reported to the TGA. Of the 77 deaths reported, one was a child under six years of age.

Reported side effects in both adults and children included:

• 13 cases of accidental overdose (resulting in 11 deaths)
• eight cases of hallucinations
• seven cases of tardy or shallow breathing (resulting in four deaths)
• six cases of decreased consciousness (resulting in five deaths).

TGA security alert comes after an internal investigation by the manufacturer of Phenergan, Sanofi-Aventis Healthcare. This investigation was initiated in 2022 advice from the Medicines Advisory Committee. The company has now updated its information for consumers and healthcare professionals.

What can you exploit instead?

If you have allergies or hay fever in teenage children, non-sedating antihistamines such as Claratine (loratadine) or Zyrtec (cetirizine) are preferred. They provide relief without the risk of sedation and other disturbing side effects of promethazine.

If symptoms of a icy or cough occur, parents should be reassured that these symptoms will usually subside with time, fluid intake, and rest.

Saline nasal sprays, adequate hydration, a humidifier or elevating the child’s head can relieve the congestion associated with hay fever. Oral products containing phenylephrine marketed for nasal congestion should be avoided because evidence shows that this is the case ineffectivebut nasal spray formulations of the drug are okay to exploit.

In case of fever or discomfort, paracetamol is a safer choice.

What else can I do?

If you have a bottle of Phenergan or a related product, avoid pouring the medicine down the sink or throwing the bottle in the trash as this may harm the environment. Instead, return it to your pharmacy for secure and responsible disposal.

The pharmacist can also advise you on the most appropriate treatment for your child and know when to seek medical aid.

If your child experiences side effects from promethazine or any other medication, call: Poison Information Center immediately on 13 11 26. In the event of an emergency in Australia, call 000.

The headline of this article has been changed to better reflect the TGA security update.