NSAIDs and cardiovascular risks: questions and answers

NSAIDs stands for non-steroidal anti-inflammatory drugs. NSAIDs are a type of medicine that is widely used to treat pain and reduce inflammation. They can be used to treat mild to moderate pain, such as headaches, migraines and dental pain, as well as the symptoms of arthritis, rheumatism, muscle strains, sprains, tendonitis and menstrual cramps.

Eight NSAIDs are available in Australia - ibuprofen, diclofenac, naproxen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam. They are marketed under a range of sometimes well-known brand names. All eight NSAIDs are available on prescription, while ibuprofen, diclofenacand naproxen are also available in lower dose over-the-counter (OTC) forms that can be obtained without a prescription, and in some cases can be bought in supermarkets and other retail outlets. Piroxicam is also available as an OTC topical medicine.

If you are unsure of whether or not a medicine is an NSAID or if you have any questions or concerns about these products, talk to a health professional.

If you have been prescribed an NSAID, then your health professional will have weighed the benefits against the risks of that treatment for your individual circumstances. Your health professional will also undertake monitoring to ensure that this treatment continues to be appropriate for you.

Do not stop taking a medicine you have been prescribed without first consulting your health professional.

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

Cardiovascular disease, sometimes called heart disease, is a class of diseases that involve the heart, blood vessels, or both. Examples include heart attack, heart failure, angina and stroke.

If you have cardiovascular disease, it is recommended that you avoid using NSAIDs due to the increased cardiovascular risks associated with these medicines. Be aware that these increased risks also relate to the use of the OTC NSAID products ibuprofen, diclofenac and naproxen. You should use an alternative medicine.

If you are unsure of whether or not a medicine is an NSAID or if you have any questions or concerns about these products, talk to a health professional.

There are a number of risk factors for cardiovascular disease, including smoking, obesity, high cholesterol and high blood pressure. If you smoke or have any of these conditions, you are at increased risk of experiencing a cardiovascular event, such as a heart attack or stroke.

If you have any of these risk factors, it is recommended that you consult a health professional before taking an NSAID due to the increased cardiovascular risks associated with these medicines. Be aware that these increased risks also relate to the use of the OTC NSAID products ibuprofen, diclofenac and naproxen.

If you use an OTC NSAID product, always read the label and follow the instructions. Do not exceed the recommended dose and only use it for short durations.

If you are unsure of whether or not a medicine is an NSAID or if you have any questions or concerns about these products, talk to a health professional.

The TGA has completed a review of the cardiovascular risks associated with the use of NSAIDs. This review found that the benefit-risk profile for NSAIDs remains positive, meaning the health benefits of these medicines outweigh the known risks for most people. However, the review also found that there is a need to raise awareness among consumers and health professionals of these risks, including that they also relate to OTC NSAID products. The TGA undertook a public consultation regarding options to reduce the risks associated with OTC NSAIDs.

Since 1 July 2016 (or 1 January 2017 in some cases where extensions were granted), all sponsors of OTC oral NSAIDs have been required to include updated warnings on their product labelling from 'Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful.' (or words to that effect), to 'Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.' (or words to that effect).

The TGA also worked with the sponsors of the innovator brands of prescription-only and pharmacist-only NSAIDs to ensure that their Product Information (PI) documents were amended to reflect the conclusions of the reviews. Sponsors of generic brands of prescription-only medicines are required to align their PI documents with safety information added to the PIs of the corresponding innovator brands.

All medicines have potential side effects. The TGA monitors adverse events relating to therapeutic goods and takes action when appropriate. The TGA's consumer information and education webpage has further information about how it weighs benefits and risks when regulating therapeutic goods.

If you suspect that you are experiencing an adverse event while taking an NSAID product, you should seek medical attention. Also, as with all other medicines, if you experience an adverse event while taking an NSAID, you can report it. You can do this by either notifying the TGA directly (by visiting TGA website and clicking on 'Report a problem') or by speaking to your health professional and requesting that they report it to the TGA on your behalf. Adverse event reports contribute to the TGA's ongoing monitoring of the safety of medicines and other therapeutic goods.