Several studies have been released this year showing that the use of NSAIDs may increase the risk of cardiac arrest and heart failure in those who are susceptible. Yet with codeine-containing analgesics about to go prescription-only, consumers may increasingly turn to NSAIDs instead.

For example, a European study of almost 10 million people found that current use (use in the preceding 14 days) of any NSAID was associated with a 19% increased risk of hospital admission for heart failure.

Another study published in the March issue of European Heart Journal – Cardiovascular Pharmacotherapy, found use of any NSAID was associated with a 31% increased risk of cardiac arrest. Diclofenac and ibuprofen were associated with a 50% and 31% increased risk, respectively.

“Owing to the widespread use of NSAIDs, even a small increase in cardiovascular risk is a concern for public health,” said two Danish heart experts in a linked editorial.

And just last week, a BMJ study of nearly 450,000 people revealed use of NSAIDs increased overall risk of a heart attack by about 20 to 50%, compared with not using these medications.

The Australian Self Medication Industry (ASMI) has hit back at the study findings, saying people who follow the on-pack instructions for OTC NSAIDs should not be concerned.

“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,” said ASMI Regulatory and Legal Director Steve Scarff.

Chief Medical Officer at the Australian Heart Foundation, Professor Garry Jennings, has also said: “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.”

“Why are NSAIDs still available in supermarkets?”

Despite reassurances from some corners of the sector, pharmacists are becoming increasingly concerned at the lack of control over NSAIDs use.

“I think the community needs to have a conversation about NSAIDs – it’s about public safety,” says NSW pharmacy owner Catherine Bronger.

“Finally we’ve got a bit of data on the danger of unscheduled NSAIDs at OTC doses.

“Sure if you don’t have a risk of a heart attack then a 20-50% increase isn’t huge, but for those who are at increased risk and possibly don’t know, up to double the increased risk in a heart attack can be significant.”

A healthcare professional should be available to discuss these risks, says Ms Bronger.

“Why are NSAIDs still available in supermarkets? In Aldi they’re right next to confectionery. You’re saying to the public that these are lollies, take as many as you like.

“I’ve seen NSAIDs in Costco on pallets in warehouse shelving, they way they stock it shows a lack of understanding of the potential risks.

“It tells consumers: stock up this is just another household item or lolly; consume as much as you like. They just shouldn’t be in supermarkets.”

Hedafen (ibuprofen) being sold next to salted peanuts and weight loss bars at a grocery store checkout. Photo: Catherine Bronger.

Cardiology experts agree with Ms Bronger. South Australian cardiologists Dr Michael Stokes and Dr Peter Psaltis have said that since OTC NSAIDs are not without risk, they should not be sold in supermarkets.

“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.

Professor Gunnar H. Gislason, professor of cardiology at Copenhagen University Hospital Gentofte, Denmark, has also written: “I don’t think these drugs should be sold in supermarkets or petrol stations where there is no professional advice on how to use them. Over-the-counter NSAIDs should only be available at pharmacies, in limited quantities, and in low doses.”

With proven lack of knowledge and health literacy surrounding the use of ibuprofen and NSAIDs, there seems to be a need for guidance from health professionals.

A recent Australian study of nearly 300 people (most of whom were over 50 years old) found almost a third could not correctly identify the safe maximum daily dose of ibuprofen.

The same amount was unaware of some contraindications such as having asthma, kidney disease or high blood pressure.

Over a fifth of the study sample (21.8%) incorrectly believed that no side effects were associated with taking these OTC products.

What will happen once codeine goes S4?

This year’s study results have brought attention to pharmacists regarding their options for OTC treatment of pain.

Once codeine products go prescription-only, the TGA is suggesting that pharmacists may be able to help manage acute pain through products containing paracetamol or ibuprofen, or the two products in combination.

But a concern is that considering the health risks presented by anti-inflammatories, pharmacists may feel the only pain relief option left to them for at-risk groups is paracetamol.

As AJP reader Geoff has recently pointed out: “This presents a problem in replacing OTC codeine combinations with ibuprofen/paracetamol combinations, really just leaving standard paracetamol as the OTC choice. Additionally all of the OTC combination packs have warnings or precautions about not taking if over 65 years old—again paracetamol is the only choice.”

“The only way to really fix this is to have an alternative to codeine come off S4 to S3, as many people cannot use an anti-inflammatory,” said another reader on the AJP Facebook page.

“Patients currently laugh at me when I recommend paracetamol… what is it going to be like when we have no other options?”

It’s likely there will be an increase in OTC pain relief medication including NSAIDs once codeine products are upscheduled, says Ms Bronger.

However if purchased in a pharmacy, at least there is a pharmacist to discuss the appropriateness of these medications for whatever pain the patient is experiencing and mitigate any risks, she says.

“In supermarkets, who can a patient ask? The checkout attendant? If there is one… They are just not equipped to sell these medicines.”

This is an edited extract of an article which appeared in the AJP.