ASMI welcomes TGA review of OTC NSAIDs

07 October 2014

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7 October 2014 - The Australian Self Medication Industry (ASMI) welcomes the release by the Therapeutic Goods Administration (TGA) of its review of cardiovascular risks of non-steroidal anti-inflammatory drugs (NSAIDs) and the announcement of its public consultation about options to reduce the risks associated with over-the-counter (OTC) NSAIDs.

The TGA reviewed the cardiovascular risks associated with eight NSAIDs, only four of which are available without a prescription. The TGA also completed a full safety review of diclofenac.

The TGA found that OTC NSAIDs are safe when they are used according to the recommended doses for short durations, as instructed on the label. However, the TGA also noted that inappropriate use or overuse of these medicines can pose a significant health risk.

In the TGA's view, there is a need to raise awareness among consumers and health professionals of cardiovascular risks of NSAIDs, and the risk of liver damage with diclofenac, for prescription and OTC medicines.

The TGA has developed four options to reduce the risks of side effects associated with OTC NSAIDs and is currently undertaking public consultation regarding these alternatives.
ASMI Director Regulatory and Scientific Affairs, Steve Scarff, said: "The industry is always concerned about the Quality Use of Medicines and medicines safety and welcomes the release of the TGA's review. We look forward to participating in the public consultation about the proposed mitigation strategies.

"Over-the-counter (OTC) NSAIDs have a known safety profile when used as directed and allow people to quickly access effective pain relief products for common problems of short duration like headache, toothache, sprains and strains.

"It is important that consumers take note of the label warnings and only use the products as directed. Importantly, 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.

For more information or to arrange a media interview, please contact:
Marie Kelly-Davies
PR Manager, Australian Self Medication Industry (ASMI)
P: 9923 9410 M:0408 256 381 E:

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 (