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OTC pain medications safe for the heart

Advancing consumer health through responsible self-care

May 11, 2017

OTC pain medications safe for the heart when used according to label instructions

Consumer healthcare products industry body, the New Zealand Self-Medication Industry (SMI), says that people who follow the on-pack instructions for over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and diclofenac, should not be concerned by reports on research associating prescription-strength with an increased risk of a heart attack.

SMI was responding to an observational study1 published in the British Medical Journal (BMJ), which has suggested that prescription-strength NSAIDs, used for treating pain and inflammation, may be associated with an increased risk of a heart attack.

Scott Milne SMI executive director, says: “The study looked at high doses and in the prescription setting. Prescribed NSAIDs are also typically used daily and for much longer durations, often to treat long-term conditions such as arthritis. OTC NSAIDs are only available in much lower doses and are used short-term for acute pain. Even in the prescription setting, this study only indicated a low risk to the heart and this risk is apparently reversible.”

The Canadian study showed that the patients’ risk of having a heart attack then decreased over time back to normal levels of risk once they stopped taking the prescribed NSAID. This indicates that NSAIDs had no lasting effect on probability of suffering a heart attack.

Speaking to The Guardian, Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said that the study was “good quality, observational research”, but added: “This study suggests that even a few days’ use is associated with an increased risk, but it may not be as clear as the authors suggest. The two main issues here are that the risks are relatively small, and for most people who are not at high risk of a heart attack, these findings have minimal implications.” He advised that it offered “no reason to induce anxiety in most users of these drugs”.

Australia’s Therapeutic Goods Administration’s (TGA) own rigorous review of the cardiovascular risks associated with OTC NSAIDs, concluded that: “These drugs provide effective pain relief when used according to the label at recommended doses for short durations,”2 and; “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

Mr Milne reminded consumers that NSAID medicines should only be used following the instructions on the labels.

“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.”

People with a history of heart disease should also speak to a pharmacist before taking any OTC medicine to check for any potential drug interactions or health concerns.


1. Risk of acute myocardial infarction with NSAIDs in real world use: bayesian meta-analysis of individual patient data, BMJ 2017;357:j1909 doi: 10.1136/bmj.j1909

2. (at page 65)



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