Paracetamol: Therapeutic Goods Administration raises concerns over common painkillers

There are serious concerns over a popular painkiller sold across Australia, which experts fear could create an overdose risk.

Australian medical regulators have called on a panel of experts to review the risks of deliberate overdoses involving easily assessable painkillers such as paracetamol.

The Therapeutic Goods Administration (TGA) has announced it has called on a group of academics to unpack the numbers on overdosing reports – including emergency department presentations and hospital admissions relating to paracetamol – in a bid to grasp whether controls on the popular painkiller need to be implemented.

“The TGA is aware of concerns, particularly of families and healthcare professionals of affected consumers of paracetamol, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets, and whether current access restrictions are appropriate,” the regulator said.

“This report is intended to assist the TGA in considering whether any changes to the scheduling of paracetamol, including access or purchasing controls, may be warranted.”

Paracetamol could be regulated to include packet limits at non-pharmacy stores. Picture: NCA NewsWire/Joel Carrett

There are currently no formal proposals outlining how regulators could tighten their grip on the drug, although some distributors have toyed with the option of enforcing buying limits on the number of packets consumers can purchase at supermarkets.

A GlaxoSmithKline Consumer Healthcare – which sells Panadol in Australia – spokesperson, which sells Panadol in Australia, told the Sydney Morning Herald the company acknowledged the importance of balancing appropriate access to paracetamol for immediate therapeutic needs alongside practical measures to support correct use.

“We share the community’s concern over the intentional misuse of medicines and the complex mental health challenges that underlie this behaviour,” the spokesperson said.

The consumer healthcare body said it would support packet limitations at non-pharmacy sites, but did not agree with a complete regulation makeover.

“We believe a responsible and balanced measure is to implement a two-pack purchase limit for all single active ingredient oral analgesics, sold outside of the pharmacy, including all online sales in addition to supermarkets and other general retail outlets,” it said.

Consumer Healthcare Products Australia, which represents sellers of the drug, has been working with policymakers to boost the safety of over the counter medicines.

“If implemented, consumers purchasing over-the-counter pain relievers (paracetamol, ibuprofen and aspirin) from supermarkets, convenience stores and petrol stations would be limited to two packs per transaction,” it said.

According to 2019 data, paracetamol was the drug most frequently involved in overdoses across the globe.

The TGA’s expert review report will be published by regulators in July.