ASMI Media Releases – Labelling NSAIDS

ASMI welcomes TGA consultation on labelling of NSAIDs
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) nonsteroidal 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.


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