New Study on Cardiovascular Safety of NSAID’s of limited relevance to OTC products

12 January 2011

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The Australian Self-Medication Industry (ASMI) today called for care in interpreting the results of a new study on non-steroidal anti-inflammatory medicines (NSAIDs).

ASMI was responding to a study published online today at bmj.comi, and related media commentary, examining NSAIDs and cardiovascular safety.

ASMI Regulatory and Scientific Affairs Director, Steven Scarff noted that the studies included in the meta-analysis involved high (prescription) doses and long-term treatment of chronic conditions. The authors of the analysis indicated that study drugs "were used for at least one year in most of the trials". Also, the Ibuprofen studies used in the analysis involved daily doses of 2400mg (twice the non-prescription dose of 1200mg).

Mr Scarff said that unlike the patterns of use in the meta-analysis, over the counter (OTC) NSAIDs such as ibuprofen, naproxen and diclofenac, are approved by the Therapeutic Goods Administration (TGA) for short-term use at low doses for self-limiting conditions.

OTC NSAIDs are safe and effective for the temporary relief of pain and inflammation.
It is important that the results of this study and the conclusions drawn by its authors are not confused with the safety profiles of OTC NSAIDs available in Australia. The lower doses of OTC NSAIDs and their short term use mean that their safety profiles are different to their higher dose, prescription counterparts.

The results of this study are therefore of limited relevance to low dose OTC NSAIDs.
It is important to read labels carefully, to strictly follow all the directions and, if pain or
other symptoms persist, to consult a doctor or pharmacist.

"The labels on OTC NSAIDs include important information to assist consumers in their
selection and use of these products with directions to seek the advice of a healthcare
professional in certain situations." Mr Scarff said.
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 selfmedication products as part of the broad national health strategy.

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298


i Trelle S et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis.
BMJ 2011;342:c7086.