A study published in the European Heart Journal – Cardiovascular Pharmacotherapy (April, 2017) reports that ibuprofen is associated with a 31% increased risk of cardiac arrest. Now some people are asking whether regulators should ban ibuprofen and other NSAIDs (non-steroidal anti-inflammatory drugs) from over-the-counter sale.
By the way, aspirin has not been linked to heart attacks or cardiac arrest. If anything, aspirin seems to reduce the risk of heart attacks.
The History of OTC NSAIDs:
Until 1984, doctors prescribed NSAIDs like ibuprofen and that prescription was the only way a patient could get any of these drugs. Then the FDA decided that it would be OK for ibuprofen (Motrin IB) to be sold without a prescription. It was advertised as “advanced medicine for pain.” In 1994, naproxen (Aleve) was also switched. Aleve was advertised with the slogan “all day long, all day strong.” Now, millions of people take OTC NSAIDs without a prescription every day. Many people believe that such medications are powerful pain relievers, far superior to aspirin or acetaminophen (Tylenol), though evidence of superiority is lacking.
Safe Enough for OTC Use?
It is estimated that nearly 30 million Americans rely on NSAIDs on a regular basis. Most people assume that if the Food and Drug Administration allows a medication to be sold without a prescription then it must be really safe. After all, such drugs are sold in supermarkets, gas stations, airport shops and goodness knows where else. No doctor or pharmacist is required. No counseling is necessary.
Many people don’t even bother to read the label. They just pop pills when they have a headache, lower back problems or arthritis in their knees or hips. How could such drugs pose a problem if the FDA gave them a green light for OTC sale?
There are, however, serious safety questions about NSAIDs.It turns out that NSAIDs and other OTC drugs may pose far greater risks than most people ever imagined.
The New Danish Research on NSAIDs:
We have known for almost a decade that NSAIDs are bad for the cardiovascular system. They increase the risk for heart attacks, strokes and congestive heart failure. These life-threatening adverse drug reactions have been demonstrated in epidemiological studies as well as randomized controlled trials (RCTs). The FDA warns health professionals:
- “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…
- “NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease…
- “There is an increased risk of heart failure with NSAID use.”
The Danish researchers have taken these concerns to another level (European Heart Journal – Cardiovascular Pharmacotherapy, April, 2017). They found that NSAIDs, especially ibuprofen and diclofenac, increase the risk for the ultimate heart problem: cardiac arrest. When your heart stops, death is not far behind. As they state in their introduction: “Cardiac arrest is the ultimate adverse drug event…” They point out that “the association between NSAIDs and cardiac arrest has never been investigated.”
Here is what they studied. In Denmark there is a nationwide Danish Cardiac Arrest Registry. They identified everyone who experienced an out-of-hospital cardiac arrest (OHCA) between 2001 and 2010. They also tracked patient use of a prescribed NSAID during the 30 days prior to the OHCA event. (In Denmark, only ibuprofen is available in pill form without a prescription. Its sale is limited to packages of no more than 30 pills. Diclofenac is available as a topical gel.)
The investigators found medical records of 28,947 people whose hearts stopped beating. Of that number, 3,376 were treated with an NSAID in the month before their OHCA. In their own words the researchers reported:
“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%]
The authors did not find a significant statistical linkage between cardiac arrest and drugs like celecoxib or naproxen. But they urged their colleagues to interpret the lack of significance “with caution.” They point out that celecoxib and naproxen are rarely used in Denmark so there may not have been enough cases to register on their radar scope.
The Conclusion From Denmark:
“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.”
The Authors Interpret Their Results:
In a press release from the European Society of Cardiology (March 15, 2017) one of the authors offered the following:
“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 author Professor Gunnar H. Gislason, professor of cardiology at Copenhagen University Hospital Gentofte, Denmark. “Previous studies have shown that NSAIDs are related to increased cardiovascular risk which is a concern because they are widely used.”
“The findings are a stark reminder that NSAIDs are not harmless,” said Professor Gislason. “Diclofenac and ibuprofen, both commonly used drugs, were associated with significantly increased risk of cardiac arrest. NSAIDs should be used with caution and for a valid indication. They should probably be avoided in patients with cardiovascular disease or many cardiovascular risk factors.”
“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.”
“The current message being sent to the public about NSAIDs is wrong. If you can buy these drugs in a convenience store then you probably think ‘they must be safe for me’. Our study adds to the evidence about the adverse cardiovascular effects of NSAIDs and confirms that they should be taken seriously, and used only after consulting a healthcare professional.”
The People’s Pharmacy Perspective:
The absolute risk of having a heart attack, stroke or cardiac arrest is relatively low. That said, tens of millions of people take such drugs regularly. Even a small risk could translate into thousands of deaths very quickly.
We were concerned when the FDA first allowed ibuprofen to be sold over the counter over 30 years ago. In those days the caution was about heartburn and other digestive tract upset. We were worried about bleeding or perforated ulcers, both of which can be life threatening. We never imagined cardiac arrest or atrial fibrillation.
We did fear that OTC status might 1) dramatically increase the number of people taking such drugs and 2) give them the appearance of safety.
Since that time many other very serious side effects have been linked to NSAIDs. They include:
NSAID Side Effects:
- High blood pressure
- Fluid retention, edema
- Heart attacks and strokes
- Cardiac arrest
- Irregular heart rhythms (atrial fibrillation)
- Congestive heart failure
- Digestive distress (indigestion, heartburn, ulcers)
- Perforation of the stomach, small intestine and large intestine
- Kidney damage, kidney disease
- Severe allergic reactions
- Toxic skin rash
- Stevens-Johnson syndrome
- Liver damage
- Blood disorders (anemia)
- Breathing difficulties (worsening asthma)
Why Is the FDA So Quiet?
Imagine for a moment that a popular herb or dietary supplement was linked to heart attacks, strokes, kidney damage or perforated ulcers. The FDA would announce to the world that there was a deadly herb loose in the land. Public health warnings would make headlines and the feds would almost assuredly ban the product from health food store shelves.
When it comes to the dangers of OTC drugs, however, the FDA seems strangely silent. We have seen no press announcements from the agency about the Danish study. There have been no announcements about stronger warnings on the labels of OTC pain relievers. We have heard not a peep about a move to ban ibuprofen from supermarket shelves. And as far as we can tell the FDA is not considering moving such drugs behind the counter.
If they are to be sold without a prescription, we think they should only be sold after pharmacist counseling. We agree with Dr. Gislason when he says: “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.” That means someone needs to contemplate an effort to ban ibuprofen and possibly other NSAIDs from easy OTC access.
If you would like to learn more about the potential dangers of NSAIDs and discover nondrug alternatives to relieve pain and inflammation, we offer our recently revised and expanded Guide to Alternatives for Arthritis. This online resource provides links to many scientific articles plus videos of home remedies. Here is a link.
Share your own thoughts on the Danish research in the comment section below.