No increased heart risk for OTC ibuprofen customers: ASMI

The Australian Self Medication Industry (ASMI) has said the recent Danish study findings associating the use of ibuprofen and other NSAIDs with higher risk of cardiac arrest should not concern those consumers of OTC ibuprofen who have none of the pre-existing risk factors stipulated on ibuprofen product labels.

ASMI notes that the study involved participants who were elderly (average age of 70), sick with pre-existing conditions, and taking other medications that increased risk factors, including morphine and anxiety medications.

The study author himself has said it is important to limit ibuprofen use to no more than 1200mg per day. This is already in line with warnings on labels for OTC ibuprofen products in Australia.

ASMI says OTC ibuprofen has a long history of safety and effectiveness when taken for a short period, as directed on the label. 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 are taking other medications.

The 10-year Danish study of nearly 30,000 patients found the use of non-steroidal anti-inflammatory drugs (NSAIDs) was associated with a 31 per cent increased risk of a cardiac arrest.

“Allowing these drugs to be purchased without a prescription, and without any advice or restrictions, sends a message to the public that they must be safe,” said the study’s author, Gunnar Gislason, Professor of Cardiology at Copenhagen University Hospital Gentofte in Denmark.

Researchers examined all out-of-hospital cardiac-arrest patients in Denmark between 2001 and 2010 using the nationwide Danish Cardiac Arrest Registry.

Data was collected on all redeemed prescriptions for NSAIDs from Danish pharmacies from 1995.

These included diclofenac, naproxen, ibuprofen, rofecoxib and celecoxib.

Out of the 28,947 patients, more than 3,300 were treated with an NSAID up to 30 days before the event. Ibuprofen and diclofenac were the most commonly used NSAIDs.

The risk of cardiac arrest was greatest among those who used diclofenac (51 per cent), while ibuprofen was associated with a 31 per cent increased risk.

Australian Heart Foundation Chief Medical Officer Garry Jennings says the findings of this study support accumulating evidence that these drugs carry a real risk for the heart.

“In absolute terms this is a relatively small risk, but it seems to be fairly real,” he said.

Despite this, there was no need to panic, Professor Jennings told Retail Pharmacy, as these drugs would not cause the ordinary customer to have a cardiac arrest – they tended 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,” he said. “I think that is very unlikely.”

Professor Jennings said the concern was that not everyone knows they have a heart problem.

He said a review was needed on all OTC pain-relieving medications, including NSAIDs, in Australia.

“There is an assumption that if you can buy something anywhere, then it must be safe, and we know these drugs are not safe,” Professor Jennings said. “This is not the only problem associated with them.

“If you do need to take these medications, make sure it’s for a very good reason and for the shortest possible time and at the lowest possible dose.

“They’re not Smarties, they’re serious medications.”

A TGA spokesperson told Retail Pharmacy that the TGA had undertaken a review of NSAIDs in 2014 and, like similar reviews from the US FDA and the European Medicines Agency, concluded that if used excessively or for long periods, they may increase the risk of heart attack or stroke.

The TGA has worked with sponsors of NSAIDs to update the product information (PI) leaflets to reflect the review findings. Prescription NSAIDs carry warnings in the PI regarding cardiovascular thrombotic risk, including heart attack and stroke. The precautions further mention that the risk may increase with dose or duration of use, and therefore the lowest dose should be used for the shortest possible duration.

In October 2014, the TGA published the reviews on its website and sought stakeholder and public comment on how the risks associated with OTC NSAIDs should best be managed or mitigated. The published reviews can be found at:

The TGA said there was general agreement from stakeholders that the risks could best be mitigated by appropriate safety warnings on product labels, complemented by communication activities.

The TGA is now implementing changes to the labels of these products following public consultations in 2015. Labelling is now required to include appropriate warnings (‘Required Advisory Statement for Labelling’) against long-term or excessive use, as follows:

“Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.”

Labelling is also required to warn against use in patients with stomach ulcer, heart failure or impaired kidney function, such as:

  • Do not use [this product/insert name of product] if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.

In keeping with usual practice for safety issues, the TGA kept consumers and health professionals informed through web statements, including a question- and-answer section: