Hundreds of people overdose on paracetamol each year

Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose. Rates of intentional overdose are highest among adolescents and young adults.

The new federal government restrictions will apply February 1, 2025. The maximum size of packs available for general sale will be reduced from 20 to 16 tablets or capsules.

Other pack sizes of up to 100 tablets or capsules will be available only under the supervision of a pharmacist.

Australians buy around a thousand tonnes of paracetamol each year.

Other measures include the Therapeutic Goods Administration encouraging retailers such as supermarkets to restrict sales to a single pack at a time.

The decision follows an an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose.

University of Sydney clinical pharmacologist Professor Nicholas Buckley said the decision reflected a need to reduce severe poisonings.

"Reducing pack sizes and making medicines prescription only have both repeatedly been proven effective methods to reduce severe poisonings," he said.

"However, all scheduling decisions are a trade off. In this case, the TGA is making a trade off between providing easy access to an affordable pain killer for the whole population and trying to reduce the severity of the 7,000 paracetamol poisonings each year."

The report found that paracetamol was the most commonly used medicine in overdoses in young Australians, at around 50 per cent.

The review noted increasing rates of intentional self-poisoning with paracetamol in the last decade in Australia, with adolescents and young adults, and females significantly over-represented in the data.

University of Sydney senior lecturer and poisons specialist Dr Rose Cairns said limiting paracetamol access would prevent accidental and intentional poisonings.

"Paracetamol is the leading cause of acute liver injury in Australia and in recent years we have seen increasing deliberate overdoses with paracetamol, particularly in young girls," she said.

"Reducing pack sizes for paracetamol is an evidence-based approach to reduce harm from these poisonings."

Millions of Australians live with chronic pain for which paracetamol is an accessible and affordable treatment option.

When the TGA first sought public consultation on the new measures in 2022 some chronic pain sufferers feared reduced access to paracetamol would create more barriers to managing pain.

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National Drug and Alcohol Research Centre senior research officer Ria Hopkins acknowledged that chronic pain sufferers relied on access to these medications.

"While limiting deaths from paracetamol poisoning is important, these medicines are commonly used to manage pain in the community, and there is a need to ensure people living with pain are not adversely affected by new restrictions," she said.

"The TGA's decision appears to have taken into consideration the need to balance limiting harms from paracetamol while still ensuring these medicines remain accessible to Australians to manage pain."

TGA is also encouraging consumers not to stockpile paracetamol.