Recent findings that NSAIDs increase risk of heart attack have minimal implications, argues ASMI
A recent BMJ study found that all non-steroidal anti-inflammatory drugs (NSAIDs), including over-the-counter medicines such as naproxen or ibuprofen, increased risk of heart attack by 20-50%.
The researchers suggested that people should consider weighing the risks and benefits of NSAIDs before beginning treatment, particularly for higher doses.
In response to the findings, Australian Self Medication Industry (ASMI) has stated that people who follow the on-pack instructions for OTC NSAIDs such as ibuprofen, naproxen and diclofenac should not be concerned.
“It is important to note that the study looked at high doses and in the prescription setting,” said ASMI Regulatory and Legal Director, Steve Scarff, in a media statement.
Mr Scarff pointed out the difference in patterns of use between prescribed NSAIDs versus OTC ones.
“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 period of time,” he said.
“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.”
Expert opinion divided?
Stephen Evans, a Professor of Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, also told The Guardian that while the BMJ study suggests that a few days’ use is associated with an increased risk, “it may not be as clear as the authors suggest”.
“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”.
In contrast, associate medical director at the British Heart Foundation Dr Mike Knapton said the study “worryingly highlights just how quickly you become at risk of having a heart attack after starting NSAIDs”.
“Whether you are being prescribed painkillers like ibuprofen, or buying them over the counter, people must be made aware of the risk and alternative medication should be considered where appropriate,” he said.
This is not the first study in recent years to find a concerning link between NSAIDs and heart disease.
One found an increased risk of heart failure in users of NSAIDs, while another an increased risk of cardiac arrest.
South Australian cardiologists Dr Michael Stokes and Dr Peter Psaltis have said that recent studies are an important reminder that NSAIDs are not without risk.
“This class of anti-inflammatory pain killers should no longer be available for sale in grocery stores, but instead restricted to prescription-only or behind-the-counter status in pharmacies,” they said.
However they added: “It is important to emphasise that in people with no known heart disease and who don’t have any heart risk factors, short-term use of these anti-inflammatories carries a minimal increase in heart-related risk.
“These recent studies should not create community panic about the safety of NSAIDs when used for short periods of time and at low dosage,” said Dr Stokes and Dr Psaltis.
In 2014, the TGA conducted a review into the cardiovascular safety of NSAIDs.
During the review the TGA highlighted that “NSAIDs are among the most commonly used pharmacological agents worldwide due to their efficacy as non-addictive analgesics and their anti-inflammatory properties.
“Hence, even a small absolute risk of serious CV effects associated with these drugs could produce a significant health burden in a given population.”
The reviewers’ conclusions were that:
- COX-2 inhibitors and most traditional NSAIDs cause similar moderately increased risks of cardiovascular disease. It is critical that both COX-2 selective and traditional NSAIDs be used with caution in patients with cardiovascular risk factors.
- Meloxicam, diclofenac and celecoxib account for almost two-thirds of all NSAID dispensings in Australia and all have been shown to be associated with significantly increased risk of stroke.
- The current Product Information (PI) and Consumer Medicine Information (CMI) documents for the innovator products for all eight NSAIDs available on prescription were found to be appropriate, adequate and representative of the current evidence regarding CV safety of NSAIDs.
- Altogether, NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal.
NSAIDs “provide effective pain relief when used according to the label at recommended doses for short durations. However, inappropriate, unsafe and overuse of these OTC NSAIDs could pose a significant health hazard,” the TGA warned in its conclusion.
“In patients with high cardiovascular risk, neither COX-2 inhibitors, non-naproxen NSAIDs or naproxen are valid or safe options.”
ASMI agrees that people at high risk for heart disease should be cautious.
“People with a history of heart disease should speak to their doctor or pharmacist before taking any OTC medicine to check for any potential drug interactions or health concerns,” it said.