Australia Issues Safety Warning Over Phenergan and Related Products Containing Promethazine

Safety Warning Issued

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), has issued a safety warning over the medicine Phenergan and related products containing the antihistamine drug promethazine. The over-the-counter products should not be given to children under six due to concerns of serious side effects including hyperactivity, aggression, and hallucination. Breathing can also become slow or shallow, which can be fatal.

What is Promethazine?

Promethazine is a “first generation” antihistamine that has been sold over the counter at pharmacies in Australia for decades for a range of conditions. Unlike many other drugs, first generation antihistamines can cross the blood-brain barrier, resulting in people feeling drowsy and sedated. In adults, this may be useful to bring on sleep. However, in children, these drugs can have serious side effects on the nervous system.

We’ve Known About This for a While

We’ve known about the serious side effects of promethazine in young children for some time. Advice about 20 years ago in the United States was not to use the drug in children under two years of age. In 2022, the Australian Advisory Committee on Medicines issued its own recommendation to increase the age to six. New Zealand issued a similar warning and advice in May this year.

What Can You Use Instead?

For allergies or hay fever in young children, non-sedating antihistamines such as Claratyne (loratadine) or Zyrtec (cetirizine) are preferred. They offer relief without the risks of sedation and the other worrying side effects of promethazine. For cold or cough symptoms, parents should be reassured that these typically get better with time, fluids, and rest.

What Else Can I Do?

If you have a bottle of Phenergan or a related product, avoid tipping the medicine down the sink or throwing the bottle in the bin, as this can harm the environment. Instead, return it to the pharmacy for safe and responsible disposal. A pharmacist can also advise on choosing the most appropriate treatments for your child, and knowing when to seek medical attention.

Conclusion

The TGA’s safety alert comes after an internal investigation by the manufacturer of Phenergan, Sanofi-Aventis Healthcare. The company has now updated its information for consumers and health professionals. Parents are advised to be cautious when giving their children over-the-counter medications, especially those containing promethazine.

Frequently Asked Questions

Q: Why has the TGA issued a safety warning over Phenergan and related products?
A: The TGA has issued a safety warning due to concerns of serious side effects including hyperactivity, aggression, and hallucination in children under six.

Q: What are the alternative treatments for allergies or hay fever in young children?
A: Non-sedating antihistamines such as Claratyne (loratadine) or Zyrtec (cetirizine) are preferred.

Q: What should I do if my child has concerning side effects from taking promethazine?
A: If your child has concerning side effects from taking promethazine, or any other medicine, call the Poisons Information Centre immediately on 13 11 26. In an emergency in Australia, call 000.

Q: Can I dispose of my unused Phenergan or related product by tipping it down the sink or throwing the bottle in the bin?
A: No, this can harm the environment. Instead, return it to the pharmacy for safe and responsible disposal.