ASMI Media Releases – New research has minimal implications for OTC painkillers when they are used according to label instructions

New research has minimal implications for OTC painkillers when they are used according to label instructions
May 10, 2017 –

The Australian Self Medication Industry (ASMI) said today that most consumers who follow the on-pack instructions for over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen and diclofenac, should not be concerned by reports on research associating high-dose, prescription strength use of these ingredients with an increased risk of a heart attack.

ASMI was responding to an observational study1 published in BMJ, which has suggested that high-dose NSAIDs, used for treating pain and inflammation, may be associated with an increased risk of a heart attack.

Steve Scarff, ASMI Regulatory and Legal Director, said:
“It is important to note that 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 taken at lower doses and are used for shorter periods of time. Even in the prescription setting, this study only indicated a small risk to the heart and this risk decreased when use of the NSAID stopped.”

People taking OTC NSAIDs should not be concerned by this research if they are taking the medicine occasionally for short periods and according to the on-pack instructions.
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”2 .

The Therapeutic Goods Administration’s 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,”3 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.”4

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

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

People with a history of heart disease should also speak to their doctor or pharmacist before taking any OTC medicine to check for any potential drug interactions or health concerns. 2

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


3. (at page 65)


Leave a Reply

Your email address will not be published. Required fields are marked *