TGA Urges Caution: Promethazine Not for Children Under 6 Due to Serious Risks

TGA Safety Alert on Promethazine for Children

The Therapeutic Goods Administration (TGA) warns against giving promethazine to children under six. Serious side effects can occur, including:

• Hyperactivity
• Aggression
• Hallucinations
• Slow or shallow breathing, which may be fatal

High doses may lead to learning difficulties, cognitive deficits, and intellectual disabilities.

What is Promethazine?

Promethazine is a first-generation antihistamine available over the counter in Australia. It treats conditions like hay fever, allergies, travel sickness, and for short-term sedation. Unlike newer antihistamines, it can affect the brain, causing drowsiness. This drowsiness may be helpful for adults but poses serious risks for children.

Historical Context

Concerns about promethazine’s side effects in young children are not new. U.S. guidelines advised against its use in children under two over 20 years ago. In 2022, the TGA recommended the use restriction be raised to children over six. New Zealand issued similar advice in May. There have been 235 reported severe side effects associated with promethazine, including 77 deaths, with one case involving a child under six.

Reported Side Effects

The reported side effects include:

• 13 accidental overdoses (11 resulted in death)
• 8 cases of hallucinations
• 7 cases of slow or shallow breathing (4 resulted in death)
• 6 cases of lowered consciousness (5 resulted in death)

Recommended Alternatives

For young children with allergies or hay fever, consider non-sedating antihistamines like:

• Claratyne (loratadine)
• Zyrtec (cetirizine)

These alternatives reduce the risk of sedation. For cold or cough symptoms, encourage hydration, rest, and time for recovery. Use saline nasal sprays and humidifiers to alleviate congestion. Avoid oral phenylephrine products for nasal congestion, as they are ineffective. Paracetamol is a safer choice for fever or discomfort.

Seek Professional Guidance

Consult a pharmacist for advice on suitable treatments and when to seek medical help.

If your child experiences concerning side effects from promethazine or any other medication, contact the Poisons Information Centre at 13 11 26. In emergencies, call 000.