OTC labels the key to safe use of NSAID painkillers

17 March 2017

Return to Media Release Index

The Australian Self Medication Industry acknowledges that a Danish study examining the use of non-steroidal anti-inflammatory drugs (NSAIDs) has further explored the association between NSAIDs and cardiovascular disease in people who are elderly, sick and using other medications. However, the study should not cause any alarm for people who do not fall into these categories and who follow the instructions on the labels of over-the-counter (OTC) NSAID medicines such as ibuprofen and diclofenac.

ASMI was responding to a recent publication in the European Heart Journal - Cardiovascular Pharmacotherapy1, which examined the use of non-steroidal anti-inflammatory drugs (NSAIDs) by patients who later experienced cardiac arrest. The study included 28,947 patients, more than 3300 of whom were treated with an NSAID up to 30 days before cardiac arrest. Ibuprofen and diclofenac were the most commonly used NSAIDs.

Steve Scarff, ASMI Regulatory and Legal Director, said: "It is important to note that the study was conducted in patients with an average age of 70 years who were prescribed NSAIDs, usually at higher doses and for longer durations than are recommended and available for OTC use.

"These elderly patients had pre-existing health conditions and were on other medications, some of which could have increased their risk factors.

"OTC NSAIDs have a good safety profile and a long history of use, allowing people to access effective pain relief products for common problems of short duration, such as headache, toothache, sprains and strains," Mr Scarff said.

The Therapeutic Goods Administration recently completed a rigorous review of the cardiovascular risks associated with OTC NSAIDs, concluding that: "These drugs provide effective pain relief when used according to the label at recommended doses for short durations,"2  and that; "The use of OTC NSAIDs was safe when they were used according to the recommended doses for short durations, as instructed on the label."3

It is important to note that the percentage increases in risk factor for cardiac arrest that have been widely reported in the media from this study are increases on a number that is already very low in otherwise healthy people. Chief medical officer at the Australian Heart Foundation, Prof. Garry Jennings, told AAP: "These drugs won't cause the ordinary person to just drop dead of a cardiac arrest, because they only tend to aggravate the symptoms of those with heart disease. There is really no information which suggests that they can cause either a cardiac arrest or heart attack out of the blue."

Mr Scarff says that it is important that consumers take note of the label warnings on NSAID medicines and use them only as directed.

"These warnings advise consumers to first seek the advice of their pharmacist or doctor if they have certain existing health problems, require longer term treatment or if they are taking other medications."

References

1. Non-steroidal anti-inflammatory drug use is associated with increased risk of out-of-hospital cardiac arrest: a nationwide case-time-control study,Eur Heart J Cardiovasc Pharmacother (2017) 3 (2): 100-107.

2. https://www.tga.gov.au/sites/default/files/medicines-review-nsaid.pdf (at page 65)  

3. https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6-number-2-april-2015