There is now new evidence which suggests there should be restrictions on both the use and sale of ibuprofen.
Ibuprofen was invented by the Boots Group during the 1960s as a medication for rheumatoid arthritis and is now one the most commonly prescribed drugs in the UK as a method of helping to relief pain from osteoarthritis, lower back pain and many other musculoskeletal conditions.
There is now new evidence which suggests there should be restrictions on both the use and sale of ibuprofen. Up until 1984 NSAIDs (non-steroidal anti-inflammatories, such as ibuprofen) were only available on prescription after which they then became freely available as over the counter medicines (OTC medicines).
However very latest research now warns that users could be more likely to suffer heart failure. It has been known that NSAIDs are detrimental for the cardiovascular system for at least a decade. This latest research from Denmark published in the European Heart Journal in April 2017 has served to convincingly underline and confirm this risk.
The study was carried out by researchers from institutions in Denmark, including Copenhagen University Hospital, Aalborg University and the University of Southern Denmark. It was funded by the European Regional Development Fund, the Novo Nordisk Foundation, and TrygFonden, a foundation that promotes public health. The authors declared no conflict of interest.
Denmark is an appropriate country for a study like this as they have a Cardiac Arrest Registry and so the raw data is readily available for research. The researchers identified everyone who had experienced an out-of-hospital cardiac arrest (OHCA) between 2001 and 2010 and tracked patient use of a prescribed NSAID during the 30 days prior to the OHCA event. It transpired that in all a total of 28,947 people had had OHCAs and, of that number, 3,376 were treated with an NSAID in the month before their OHCA.
Researchers commented:
“In this nationwide case-time control study, we found that use of nonselective NSAIDs was associated with an increased risk of OHCA. The result was primarily driven by an increased risk of cardiac arrest in ibuprofen and diclofenac users…
“In this study, short-term use of ibuprofen was associated with an increased risk of cardiac arrest, OR [odds ratio] 1.31…” [That is an increased relative risk of 31%.]
“We found that diclofenac was associated with an increased risk of cardiac arrest, OR 1.50, which concurs with findings in several other studies.” [That is an increased relative risk of 50%]
“Our findings support the accumulating evidence of an unfavourable cardiovascular risk profile associated with use of the non-selective NSAIDs. This calls for special awareness in order to balance risks against benefits in treatment with NSAIDs.”
In summary therefor the Danish researchers found conclusively that NSAIDs statistically (especially ibuprofen and diclofenac) increase the risk of cardiac arrest.
The U.S. Food and Drug Administration (FDA) is also strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. The FDA concludes the following
The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
•The risk appears greater at higher doses.
•It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
•NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
•In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
•Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
•There is an increased risk of heart failure with NSAID use.
It is worth pointing out that naproxen is not widely used in Denmark and was not included in the report. Furthermore diclofenac is no longer available except on prescription in the UK because of concerns about its effect on the heart. Ibuprofen of course on the other hand is still openly available as an OTC product. Also it is important to point out aspirin has not been linked and/or contraindicated as it seems to reduce the risk of heart attacks.
Furthermore the dose and duration of NSAIDs used in this study might have varied across participants. It’s not clear whether the greater the dose or duration, the higher the risk of cardiac arrest. As the study was carried out in Denmark – the findings might not be as relevant to other populations, who have different lifestyles.
