Non-steroidal anti-inflammatory drugs and diclofenac reviews

Safety advisory

7 October 2014

Consumers and health professionals are advised that the TGA has completed a review of the cardiovascular risks associated with the use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam.

In addition to this review, the TGA has also completed a full safety review of diclofenac.

NSAIDs are widely used to treat pain and reduce inflammation. They can be used to treat the symptoms of arthritis, rheumatism, muscle strains, sprains, tendonitis and menstrual cramps.

All eight NSAIDs are available on prescription, while diclofenac, naproxen and ibuprofen are also available in lower dose over-the-counter (OTC) forms that can be obtained without a prescription. Piroxicam is also available as an OTC topical medicine.

Review findings

The reviews involved evaluation of relevant medical literature, assessing input from sponsors and industry stakeholders, and obtaining expert advice from the Advisory Committee on the Safety of Medicines.

The full NSAIDs and diclofenac reviews are now available on the TGA website.

In summary, while use of NSAIDs at prescription-only dosages was already known to increase the risk of high blood pressure, heart failure, heart attack and stroke, the TGA NSAIDs review found that these risks also applied to OTC forms of diclofenac, naproxen and ibuprofen.

Similarly, the risk of hepatotoxicity (commonly known as liver damage) in relation to use of prescription diclofenac was known, but the TGA's safety review of that medicine found that OTC diclofenac products also carried this risk.

The TGA reviews found that there is a need to raise awareness among consumers and health professionals of the cardiovascular risks associated with NSAIDs and the additional hepatotoxicity risks for diclofenac, including OTC versions of these medicines.


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

The product labelling for OTC diclofenac, naproxen and ibuprofen does not carry adequate warnings regarding the risks of adverse cardiovascular events or, in the case of diclofenac, hepatotoxicity.

The TGA has developed four options to reduce the risks associated with OTC NSAIDs and is currently undertaking public consultation regarding these alternatives.

Information for consumers

Use of NSAIDs can increase the risk of adverse cardiovascular events.

If you or someone you care for has pre-existing cardiovascular disease or risk factors, you should consult a health professional before using these products and consider using an alternative medicine.

If you use an OTC NSAID (diclofenac, naproxen or ibuprofen), regardless of whether or not you have risk factors for cardiovascular disease, read the label and follow the instructions. Do not exceed the recommended dose and only use it for short durations.

The TGA has published a consumer Q and A with further information about this issue.

If you have any questions or concerns about this issue, talk to your health professional.

Information for all health professionals

Health professionals are reminded of the cardiovascular risks associated with treatment with NSAIDs and the additional risk of hepatotoxicity with diclofenac.

Avoid using prescription NSAIDs in patients who have previously had myocardial infarction, angina, cardiac failure, hypovolemia, significant peripheral vascular disease or pre-existing significant renal/liver dysfunction.

Use these medicines with caution in patients with risks factors for cardiovascular disease, undertaking individual assessment of each patient to ensure the benefits outweigh the risks.

Consider advising patients who have risk factors for cardiovascular disease of the increased risks of using NSAIDs, including OTC products, and educating them regarding the signs and symptoms of serious cardiovascular toxicity. Instruct them to seek medical attention immediately if they experience any.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.