May 10, 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)



About SMI: The New Zealand Self-Medication Industry Association Inc (SMI) is the national trade association representing manufacturers, marketers and distributors of a wide range of products, generally available “over-the-counter” (OTC) and mainly for use in self-medication by New Zealand consumers. Membership totals 44 companies of which 12 are the country’s largest drug manufacturers, importers and distributors; the balance is made up of smaller OTC manufacturers and distributors and Complimentary Health Care companies.

SMI’s mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all New Zealanders at a reasonable cost. SMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy.

Media contacts: Scott Milne, Executive Director NZSMI Tel + 64 9 528 8217 Mob: +64 21 876 326 or Brenda Saunders, 021 777 171.

New Zealand Self-Medication Industry Association Inc.

PO Box 6473, Auckland, New Zealand   Phone/Fax (09) 235 5260