Therapeutic Goods Administration Says Children Under Six Should Not Use Phenergan, Parents Said Side Effects Are Rare

This week, the Therapeutic Goods Administration (TGA) issued an alert stating that children under the age of six should not receive promethazine hydrochloride.

The medication, commonly known by the brand name Phenergan, is used to treat allergies and hay fever, as well as for short-term sedation.

Here’s what parents need to know about the new rules.

What has the TGA said about this drug?

They say it should not be used in children under six years old.

“These products can still be used in children six years and older for their approved indications,” said a TGA spokesperson.

The advice for children under six years of age concerns, at the moment, only the oral form of the medicine.

“At this stage, the updated advice does not apply to the sole intravenous form of promethazine hydrochloride available in the Australian market, noting that this product is only available with a doctor’s prescription.”

Why can’t children under six follow it?

The TGA states that there are “risks of psychiatric and central nervous system side effects”, including:

• hyperactivity
• assault
• hallucination

“When high doses are given, these children may also experience learning and comprehension difficulties, including reversible cognitive deficit and intellectual disability“, the TGA said in its security alert.

What do we know about side effects?

We spoke to Nitin Kapur, pediatrician and director of pediatric education at Queensland Children’s Hospital, about psychiatric and central nervous system side effects.

“These side effects are well known although rare,” said Dr. Kapur.

“(I) don’t think the effects are long-term, so if parents haven’t seen them yet, they won’t see it if they stop Phenergan now.”

He said these side effects are usually only present when the child is taking the medication.

We also asked him about the possibility of a reversible cognitive defect and intellectual disability.

“Reversible means the side effects will subside once treatment is stopped,” he said.

What is the risk?

The ABC asked the TGA what the risk of side effects was for children under the age of six using this medicine.

A TGA spokesperson did not give a specific figure, but said the recommendation was based on a study conducted by Sanofi-Aventis Healthcare, the pharmaceutical company that markets Phenergan.

“These data demonstrate sufficient evidence that promethazine hydrochloride could potentially cause psychiatric and central nervous system side effects in children two to five years of age,” the spokesperson said.

“The TGA applies its scientific and clinical expertise to its decision-making to ensure that, based on currently available data, the overall benefits of a product outweigh the risks in the intended population, when used for approved indications.”