Over-the-counter NSAIDs safe for short-term use

13 February 2013

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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 follows the publication of a research article in PLoS Medicine, which reviewed the increased risk of cardiovascular events in patients taking a number of different NSAIDs. The researchers concluded that the risks associated with diclofenac in vulnerable patients was higher than for NSAIDs such as naproxen. [1]

ASMI has urged caution in interpreting the research results, noting that no new data on cardiovascular risk had been included in the analysis and, importantly, that the analysis did not segregate prescription and over-the-counter (OTC) NSAID data.

"Over-the-counter NSAIDs allow people to quickly access effective pain relief products for common problems like headache, toothache, period pain and sprains and strains. They are intended for short-term use only and contain low doses of active ingredient. It's important that conclusions drawn by the researchers of this study are not confused with the safety profile of OTC NSAIDS that are available here in Australia," explained ASMI Regulatory and Scientific Affairs Director, Steven Scarff.

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 high risk conditions such as people with heart problems or liver disease.

Mr Scarff also pointed out that the study did not present a balanced view in terms of acknowledging the clinically proven benefits provided by NSAIDs and, more importantly, that it did not look at the risk profiles of the patients taking the NSAIDs.

The European Medicines Agency (EMA) finalised a review of published data on cardiovascular safety of NSAIDS in October 2012. [2]

Most of the EMA data related to the three most widely used NSAIDS - ibuprofen, naproxen and diclofenac. In relation to naproxen and ibuprofen, the EMA found that current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines. For diclofenac, the latest evidence appears to show a consistent but small increase in the risk of cardiovascular effects compared to other NSAIDs. [2]

ASMI believes this risk has been overstated in McGettigan and Henry's latest analysis.

"It is important that consumers take note of the label warnings and only use the products as directed. Based on all the information available, we believe that the label warnings on OTC NSAIDs remain appropriate. Among other things, these warnings advise consumers with certain existing health problems or who are taking other medications to first seek the advice of their healthcare professional," Mr Scarff added.

1.    McGettigan P, Henry D (2013) Use of Non-Steroidal Anti-Inflammatory Drugs That Elevate Cardiovascular Risk: An Examination of Sales and Essential Medicines Lists in Low-, Middle-, and High-Income Countries. PLoS Med 10(2): e1001388.
2.    European Medicines Agency (2012). European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs. EMA/CHMP. 667707. 2012.