TGA mulls restricting paracetamol sales after report raises concerns about overdoses in teens

Paracetamol sales could be restricted in Australia after an independent expert report stated there had been a “concerning increase” of misuse among teens.

The concern about overdoses in the age group has prompted the national medicines regulator to consider restrictions, including purchase limits of one or two packs per person, as well as prohibiting sales to under 18s without a prescription.

The Therapeutic Goods Administration announced on Thursday it would begin a consultation process regarding the seven recommendations made in the report it commissioned.

The report found the rates of intentional paracetamol overdose were highest among adolescents and young adults, and more common among females.

Recent data shows that each year in Australia, paracetamol overdose leads to around nine people per million hospitalised with liver injury and two deaths per million – or about 50 Australian lives lost.

“While hospitalisation and death rates have not increased in recent years, there is a concerning increase of misuse in the community,” the TGA said.

Survival rates from a paracetamol overdose are excellent, but only where medical treatment is sought within two to six hours after ingestion, the regulator said.

If treatment is delayed after ingesting high doses of paracetamol, there is a risk of serious liver injury and sometimes death.

The expert panel which wrote the report for the TGA made four recommendations regarding the sale of paracetamol, a staple pain relief medication sold under common brand names such as Panadol and Tylenol.

These included reducing the size of packs sold in supermarkets and convenience stores without a prescription, and in pharmacies without the advice of a pharmacist; and limiting transactions to one or two packs to reduce home stockpiles.

They also included restricting purchases without a prescription to people aged 18 and over and making modified-release paracetamol prescription only.

The panel made three additional recommendations: improving communication around the potential harms from paracetamol, maintaining and expanding follow-up care and support after self-harm and increasing awareness about safer medicines storage and reducing stockpiling.

The Advisory Committee on Medicines Scheduling has advised the TGA it would be beneficial for the regulator to consult widely on the possibility of amending the poisons standard.

The TGA’s consultation is open until October 14.

Originally published as TGA mulls restricting paracetamol sales over teen overdose concerns