ASMI: Consumers can have confidence in OTC painkillers when used as directed

Consumers can have confidence in OTC painkillers when used as directed

9 February, 2018 –

The Australian Self Medication Industry (ASMI) today assured consumers that over-the-counter (OTC) oral analgesic products containing ibuprofen, paracetamol and diclofenac remain a safe and effective means of relief from acute pain when used short-term and according to label instructions.

This statement comes in response to a report[1] about a range of painkillers in the wake of all codeine-containing products being upscheduled so that they are only available with a prescription. The report referred to research that studied the use of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac) long-term and in high doses, which is not applicable to OTC oral analgesic products.

    ASMI Regulatory and Legal Director, Steve Scarff, says, “It important to distinguish the use and safety of OTC ibuprofen from that of long-term and/or high-dose prescription ibuprofen.”.

  Consumers should note that in Australia, the Therapeutic Goods Administration (TGA) has assessed diclofenac, ibuprofen, naproxen and paracetamol, and all were judged to be effective and consistent with a safety profile that warrants consumer access without a prescription. Earlier this week, the Scheduling Delegate issued an interim decision recommending that OTC ibuprofen remain accessible through grocery outlets, citing reasons which included minimal risk of misuse or abuse; a wide therapeutic window; the propensity for toxicity in overdose is low, and there are no new safety concerns.

  “However, all these OTC analgesics are only intended for the relief of acute or short-term pain/fever conditions and are not intended to be used on a long-term basis unless directed by a doctor,” says Mr Scarff.

  For longer-term pain and chronic conditions such as osteoarthritis, it is necessary to consult a doctor, who will advise if you should use these medicines as part of your treatment.

  ASMI believes that current product labels for OTC oral analgesic products include sufficient information to help consumers use these products safely and effectively.

  “Label instructions advise consumers to first seek the advice of their doctor or pharmacist if they have certain existing health problems, are elderly, require longer-term treatment or if they are taking other medications,” Mr Scarff says.


1. Beyond codeine – more risks identified with other painkillers, Sydney Morning Herald, 9 Feb. 2018