TGA announces NSAIDs review

12 October 2016

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TGA announces NSAIDs review
11 October 2016
The TGA's publication of a review for non-aspirin NSAIDs (non-steroidal anti-inflammatory drugs) found that current advisory statements on labels did not consistently address risks, and this has resulted in a proposal to review the requirements.
If you are pregnant, think you may be pregnant or are trying to become pregnant, ASMI advises that you consult a health professional before using any over-the-counter medicines, even NSAIDs.
The TGA review was not prompted by new evidence about the risk of NSAIDs to pregnant women or by an increase in incidents involving pregnant women and commonly used NSAID medications. The review instead aims to achieve consistency among label warnings for non-aspirin NSAIDs, with warnings extended to cover not only women who are pregnant, but also those who may become pregnant and those who are trying to become pregnant.
Consequently, these label warnings will also apply to period-pain specific NSAID products. Given the intended use of these products (period pain), they are currently not required to carry the pregnancy warning. In the interests of consistency, this warning will also be extended to cover these products.
The revised warnings only apply to oral products such as tablets, liquids and capsules. They do not apply to topical preparations such as gels, creams and sprays.
Use of non-aspirin NSAIDs is known to be associated with an increase in the risk of miscarriage, particularly when taken close to the time of conception. There are many other individual factors that can increase the risk of miscarriage, including advanced age, smoking, obesity and other medical conditions.
ASMI advises that anyone using an over-the-counter medicine should always read the label and follow the instructions.
If you have any questions or concerns about this issue, please talk to your health professional.
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak body representing sponso
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:
Dominic Cadden
Communications Manager, Australian Self Medication Industry (ASMI)
P: 9923 9410 M:0408 256 381 E: