Released by the Australian Drug Regulator. Safety warning The drug Phenergan and related products contain the antihistamine drug promethazine.
The Therapeutic Goods Administration said long-term products mustn't be given to children under the age of six due to concerns about serious negative effects, including hyperactivity, aggression and hallucinations. Breathing may be slow or shallow, Which can be fatal.
When high doses are given, young children may experience learning and comprehension problems, including reversible cognitive deficits and mental disabilities. said the TGA.
The latest warning follows international and Australian concerns in regards to the drug in young children, which is usually used to administer 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 pharmacies in Australia for a lot of conditions for a long time.
Unlike many other drugs, first-generation antihistamines can cross the blood-brain barrier. This signifies that they affect brain chemistry, causing people to feel drowsy and faint.
In adults it might be useful for inducing sleep. But in children, these drugs can have serious negative effects on the nervous system, including those listed on this week's safety alert.
We've known about this for some time.
We have known for a while in regards to the serious negative effects of promethazine in young children.
Advice about 20 years ago In the United States, the drug was to not be utilized in children under the age of two. Australians in 2022 Advisory Committee on Medicines It has issued its suggestion to extend the age to 6. Released by New Zealand Similar warning and advice In May this 12 months.
Over the past ten years, there have been 235 cases of significant negative effects of promethazine in each children and adults. Reported to TGA.. Of the 77 reported deaths, one was a toddler under the age of six.
Side effects reported for each adults and youngsters include:
- 13 cases of accidental overdose (leading to 11 deaths);
- Eight types of delusion
- Seven cases of slow or shallow respiration (leading to 4 deaths)
- Six cases of lack of consciousness (leading to five deaths).
TGA safety warning comes after An internal investigation by Sanofi-Aventis Healthcare, the manufacturer of Phenergan. The investigation was conducted till 2022. advice From the Medicines Advisory Committee. The company has now updated its information for consumers and health professionals.
What can you employ as an alternative?
For allergies or hay fever in young children, Non-sedating antihistamines Such as Claratyne (loratadine) or Zyrtec (cetirizine) are preferred. They provide relief without the risks of sedation and other annoying negative effects of promethazine.
For cold or cough symptoms, parents ought to be reassured that these often get well with time, fluids and rest.
Saline nasal sprays, adequate hydration, a humidifier, or elevating the newborn's head can reduce congestion related to hay fever. Oral phenylephrine products, that are marketed for nasal congestion, ought to be avoided, as evidence suggests that they ineffectivebut nasal spray formulations of the drug are high-quality to make use of.
For fever or discomfort, paracetamol stays a protected selection.
What else can I do?
If you could have a bottle of Phenergan or a related product, avoid tipping the drug down the sink or throwing the bottle within the trash, as this may harm the environment. Instead, return it to the pharmacy for protected and responsible disposal.
A pharmacist may also advise on selecting probably the most appropriate treatment on your child and when to hunt medical attention.