The Australian Medicines Regulatory Authority safety warning About the drug Phenergan and related products, including the antihistamine promethazine.
The Medicines Agency said the over-the-counter product should not be given to children under 6 due to concerns about serious side effects, including hyperactivity, aggression and hallucinations. Breathing may also become slow or shallow. it can be deadly.
At high doses, young children may experience learning and comprehension difficulties, including reversible cognitive deficits and intellectual disability. TGA said.
This latest warning follows international and Australian concerns about medicines for young children commonly used to manage conditions such as hay fever and allergies, motion sickness and 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 brain chemistry, resulting in people feeling drowsy and sedated.
For adults, this may help bring about sleep. But in children, these drugs can cause serious side effects on the nervous system, including those listed in this week’s safety alert.
we’ve known about this for a while
Serious side effects of promethazine in young children have been known for some time.
advice about 20 years ago In the United States, this drug should not be used in children under 2 years of age. Australia in 2022 Pharmaceutical Advisory Committee issued its own recommendation to raise the age to six years. issued by new zealand Similar warnings and advice In May of this year.
Over the past 10 years, 235 serious side effects of promethazine have been reported in both children and adults. Reported to TGA. Of the 77 deaths reported, one was a child under the age of six.
Side effects reported in both adults and children include:
- 13 accidental overdoses (11 deaths)
- 8 hallucinations
- 7 cases of slow or shallow breathing (4 deaths)
- Six people experienced decreased consciousness (five died).
TGA Safety Warning come later An internal investigation by Sanofi-Aventis Healthcare, the manufacturer of Phenergan. This study was conducted in 2022 advice From the Pharmaceutical Advisory Committee. The company has now updated information for consumers and medical professionals.
What can I use instead?
For allergies and hay fever in small children, Non-sedating antihistamines Something like Claratyne (loratadine) or Zyrtec (cetirizine) are preferred. These provide symptomatic relief without the risk of sedation and other concerning side effects of promethazine.
Parents can rest assured that cold and cough symptoms usually improve with time, hydration, and rest.
Saline nasal sprays, proper hydration, a humidifier, or elevating your child’s head can help reduce nasal congestion associated with hay fever. Oral phenylephrine products marketed for nasal congestion should be avoided as evidence suggests. no effectHowever, the nasal spray formulation of this drug is safe to use.
For fever and discomfort, paracetamol is a safer option.
What else can I do?
If you have a bottle of Phenergan or a related product, do not drop the medication down the sink or throw the bottle in the trash, as this may harm the environment. Instead, return it to your pharmacy for safe and responsible disposal.
A pharmacist can also help choose the best treatment for your child and advise you when to seek medical care.
If your child experiences any concerning side effects from taking promethazine or any other medication, please call us. Poison Information Center I will contact you immediately on 13 11 26. For emergencies in Australia, call 000.
