Serious concerns could see over the counter paracetamol access curbed

The Therapeutic Goods Administration (TGA) has announced a panel of experts will assess the risks of overdose from the common pain relief medication, paracetamol.

The medication overseer has noted reports of accidental and intentional overdoses from the painkiller and will be investigating whether limiting its access will help remove overdose risks.

The TGA said the panel will be comprised of independent experts.

“Paracetamol is the most widely used pain relief medicine in the world that is available without a prescription,” the TGA said in a statement.

“While paracetamol has well established safety and toxicity profiles, the wide use is paralleled by a high prevalence of accidental and deliberate paracetamol poisoning in the community, in both adults and children.”

The TGA said that current access to paracetamol is already restricted through the Poisons Standard, in ways of dosage and number of tablets allowed to be sold in retail and over the counter pharmacy sales.

“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 statement said.

“Currently, there are no applications to amend the Poisons Standard with respect to paracetamol. 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.”

The Sydney Morning Herald reported a spokesperson for Australian Panadol retailer GlaxoSmithKline Consumer Healthcare said: “We acknowledge the importance of balancing appropriate access to paracetamol for immediate therapeutic need alongside practical measures that support correct use.”

“Based on the available evidence, we believe the current scheduling of paracetamol in Australia remains appropriate,” the spokesperson said. 

“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. This would further support medicines safety while maintaining convenient access to pain and fever relief.”

This is not the first time over the counter medication has been assessed for potential risks.

A recent draft study from The U.S. Preventive Services Task Force saw the common recommendation for the use of aspirin to lower the risk of a first heart attack and stroke for older adults revoked.

The blood-thinning medication, known for preventing heart attacks and strokes by stopping blood clots from forming, was found to hold bleeding risks for adults in their 60s and older who hadn’t suffered from heart attacks or strokes.

The findings of the TGA’s commissioned review will be released in a report in July 2022.

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UPDATED to include a full quote from GlaxoSmithKline Consumer Healthcare. May 16, 2022, 11:00AM.