Over-the-counter pain medicines safe for short-term use

31 May 2013

Return to Media Release Index

31 May 2013 - The Australian Self Medication Industry (ASMI) has moved to reassure consumers taking low-dose non-steroidal anti-inflammatory drugs (NSAIDs) for short-term pain relief that these medicines are safe when used as directed.
The advice from the Australian Self Medication Industry (ASMI) follows new research published in The Lancet, which found a number of different NSAIDs increase the risk of cardiovascular events and gastrointestinal complications. However, these NSAIDs were taken at high doses for extended periods to treat or prevent chronic diseases.1
In the meta-analysis, the authors reviewed 639 clinical trials that included more than 300,000 patients using NSAIDs and Cox-2s (newer NSAIDs) at prescription doses.
Commenting on the study, ASMI Regulatory and Scientific Affairs Director, Steven Scarff, said:
"This is a very well-designed and robust study which is likely to help consumers and healthcare professionals work together to make informed decisions about the long-term use of high-dose NSAIDs in individuals living with painful chronic conditions.

"However, it is important that the results are not confused with the safety profiles of over-the-counter (OTC) NSAIDs. The lower doses of OTC NSAIDs and their short term use mean that their safety profiles are different to their higher dose, prescription counterparts.

OTC NSAIDs are commonly used to provide pain relief for common problems such as headache, toothache, period pain and as sprains and strains. They contain lower doses of active ingredient and are intended for short-term use only, normally under a week.
Mr Scarff noted that the studies included in the meta-analysis involved high (prescription) doses and long-term treatment of chronic conditions. For example, the study looked at patients taking 2400 mg of ibuprofen per day, double the maximum daily dose of 1200 mg that is approved in Australia for OTC ibuprofen.1

Also, unsurprisingly, the study found that patients considered to be at increased risk of cardiovascular or gastrointestinal complications were those with a previous history of heart disease, high blood pressure or cholesterol.1

The study authors also suggest that lower doses of NSAIDs are likely to be associated with lower risk.

In Australia, rigorous controls on the registration and labeling of OTC NSAIDs (such as ibuprofen, naproxen and diclofenac) are in place. All are approved by the Therapeutic Goods Administration (TGA) for short-term use at low doses for self-limiting conditions and contain warnings on the label for anyone who is in a high risk category such as the elderly and people with heart problems or liver disease.

As with any medicine, consumers are encouraged to seek advice from their healthcare professional on appropriate use of medicines.

About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Reference 1: Coxib and traditional NSAID Trialists' (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. The Lancet 30 May 2013 DOI: 10.1016/S0140-6736(13)60900-9.