ASMI welcomes TGA consultation on labelling of NSAIDs

05 February 2015

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5 February 2015 - The Australian Self Medication Industry (ASMI) today welcomed a Therapeutic Goods Administration (TGA) consultation on the labelling of oral over-the counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs).
Last year the TGA conducted a review of the cardiovascular safety of NSAIDs and the safety of diclofenac. In that review ASMI recommended that warning statements be included on labels about the cardiovascular risks of prolonged use of NSAIDs. As a result of the review, the TGA has decided that NSAID medicines should include an advisory statement to the effect that excessive or prolonged use can increase the risk of heart attack or stroke.

Steve Scarff, ASMI Director of Regulatory and Scientific Affairs, said: "ASMI welcomes the TGA's consultation on advisory statements for NSAIDs. The industry is committed to Quality Use of Medicines and supports improved labelling.

"All medicines have benefits and risks. For OTC medicines the label provides the necessary information to help a consumer understand if the medicine is right for them and when to seek advice from a pharmacist or doctor.
"We urge consumers to always read the label and follow the instructions for use," he added.

About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines (CM). ASMI members make up 85 per cent of the $4bn Non-Prescription Medicines market. Membership totals 50 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to advance consumer health through responsible self-care. This means driving a viable and responsible industry and empowering the consumer with evidence-based products and information with the aim of improving health and wellbeing. To find out more about ASMI or how to become an ASMI member, please visit (

For more information or to arrange a media interview, please contact:
Marie Kelly-Davies
PR Manager, Australian Self Medication Industry (ASMI)
M:0408 256 381 E: