ASMI advice regarding the use of NSAIDs and the risk of stroke

07 November 2011

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Current label warnings and existing advice regarding the non-prescription use of non- steroidal anti-inflammatory drugs (NSAIDs) remains sound, in light of a new study that examines the use of these medicines and the risk of stroke in older patients, the Australian Self-Medication Industry (ASMI) said today.

The study, published in the Medical Journal of Australia, examines the use of prescription doses of NSAIDs in an Australian veteran population with an average age of 76 years.i
In this setting, the authors concluded that the prescription use of NSAIDs was associated with an increased risk of stroke. However, as the authors said, the absolute risk is low and the increased risk found is therefore also small.

"Importantly this study did not examine lower non-prescription doses or over-the-counter (OTC) use of NSAIDs, and was conducted in a very specific study population. Many of the veterans studied suffer from a range of medical conditions and will, on average, be prescribed 11 unique medicines in a year," said ASMI Regulatory and Scientific Affairs Director, Steven Scarff.

The study in question was an observational study in a veteran population with comorbidities, and was based on hospitalisation records and prescription use of NSAIDs. The authors state that "the analysis is associative only and does not prove causality".
While the authors were unable to examine the OTC use of NSAIDs, they did find no association between Ibuprofen use and an increased risk of stroke in this specific population.

Generally speaking, OTC NSAIDs are safe and effective for the temporary relief of pain and inflammation.

"OTC use of NSAIDs involves taking low doses for short periods of time. Anyone who is in a high risk category, such as the elderly or people with heart problems, should, as with any medication, consult their GP or pharmacist before using an NSAID.

"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 these label warnings and advice around these products remains appropriate.

"Among other things, these warnings advise elderly consumers and those with certain existing health problems or who are taking other medications to first seek the advice of their healthcare professional.

"It is important to read labels carefully, and to strictly follow all the directions and, if the pain or other symptoms persist, to consult a doctor or pharmacist," Mr Scarff said.


1 Caughey E. Et al; Stroke risk and NSAIDs: an Australian population-based study, Medical Journal of Australia, 7 November 2011, MJA 195 (9).
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.

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 2