aspirin bottle and bottles of Motrin IB (ibuprofen) and Advil

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.

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  1. KMC
    South Carolina

    At least we do have more information now and have to take responsibility for ourselves and not over medicate. I’m in constant pain with feet, back, shoulders from delivery of mail and tennis leagues. I don’t take anything because of stomach issues. Sinus headache sometimes last 3 days. But I do use steroid gel on back occasionally but health plan refuses to pay for it. Going start meditation and more exercise (I’m not over weight) to maybe zone out pain. There are lots of holistic and approach avenues with herbal supplements or massage.

  2. SHP

    Everything we put in our mouths carries risk, virtually everything.
    Given the choice of being able to function or risk side effects from OTC ibuprophen, I’d like to be the one to make that decision, and will accept the risks.
    When has government hyper-oversight truly protected us from ourselves, or from those more interested in profits?
    I believe those in pain have a right to safe, effective relief, no matter what the source. However, It does not appear that is what the pharmaceutical industry is offering.
    As long as access to treatment is controlled by the industries that have the ear of the government and not by the individuals who actually pay for that treatment, there will never be true reform that will benefit the individual.

  3. Zbigniew J Gorecki

    Thank you The People’s Pharmacy for all information helping to cope with health problems.

  4. Bonnadee

    We should NOT ban ibuprofen. I take it only on occasion (twice a month or so). Aspirin and Tylenol don’t do anything for me. What else can people like myself do? Narcotic drugs are definite overkill and unnecessary.

  5. Janet

    There does not seem to be enough information in the article to support the conclusion. They say, “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.” There needs to be a comparison group of people who did not have an OHCA. How many of them had taken an NSAID within the previous month? They not only did not justify a causal relationship, they did not justify a correlative relationship. Of course, it’s possible that the study did do that, but that the authors of the article did not report correctly on the study.

  6. Bob
    Chapel Hill, NC

    I had to stop regular use of naproxyn because of kidney damage. After 40 years of practice in orthopedic surgery and stopping the prescribing of butazolidin because it caused leukemia and a number of others because those NSAID’s caused heart attacks, I had to stop what I thought was “Safe”!

  7. Anne

    I’m not sure how to feel about this. I used ibuprofen for years, once a month for menstral cramps that were debilitating, and it made a huge difference. I just took 2 tonight (and plan on taking one more because that seems to be what works best) for back pain after cleaning up the horse paddock. I’m 65, and even though I exercise and am careful about lifting I still run into problems. I don’t take ibuprofen on a regular basis, and never for more than a few days. But it works. If I had to get a prescription every time I needed it, I’m not sure what I’d do.

    No matter what you put out there, some people will abuse it. How do we make good decisions for the majority? Yes, some people will have strokes or other bad side effects. But what are the percentages? We make a lot of decisions to allow everyone to use things (think alcohol) that some people absolutely cannot tolerate.

    I’m not saying I’m right. I’m asking questions.

  8. B

    I used ibuprofen along with immobilization to CURE tendinitis back in the 90’s. Only I took one to many. That evening, I was in familiar territory, however, I didn’t have a clue where I was. This loss of spacial memory went away the next day, but I had occasional flash backs for the next few years.

  9. Patty

    I have known people who have taken OTC drugs without paying any attention to the dosage info. They think the pills are harmless. If 1 pill is the dosage, then 4 is better. Also OTC and RX drugs may not be for everyday, all day for the rest of your life. yet, that is what people end up doing. Doctors do not take the time to advise patients on this. RX mood and pain pills are dispensed at whim. They were never meant to be taken long term. Patients become addicted and can’t stop until they are dead. These Mood and Pain pills stop working, so patients self medicate with higher doses until they overdose.

  10. mary

    Both my mother -in law and my mother almost died from this drug.
    I told the ambulance drivers I thought my mom was bleeding internally she was and almost died.
    My mother in law was bleeding internally, we were able to get her to the hospital before she died.

  11. Thai

    I think a middle ground might be the best way to allow purchase of ibuprofen and naproxen to be available without having to make a doctor’s appointment, which would cause unnecessary expense and limit who can benefit from the real pain relief these OTC drugs provide. Requiring a pharmacist’s consultation to explain the serious aspects of taking these drugs before they can be purchased makes good sense. Warnings on packages or literature given with purchase isn’t enough now that it’s known life threatening events can happen when taking these drugs.

  12. Terry

    OK. Understood. However, one 200 mg tablet keeps my enlarged prostate at bay at night making it possible to sleep longer through the night. Am I in danger of the same risks as others who take much higher doses?

  13. Kansaskalamity
    Wichita, Kansas.

    I’m wondering if this includes Anacin. I have been taking Anacin since the 70’s. I take two anytime I feel a headache coming on. I cannot stand head pain!!! This is the only thing that helps me. Even a prescription of Tramadol doesn’t help. I will take 3 if the onset of a headache seems more severe. I have lived with pain since my 30’s and I am not almost 70. If it were not for Anacin I would not be able to cope. In fact, drugstores don’t even carry Anacin anymore and they looked puzzled when I ask for it. But I can get it through Amazon Prime and it is much cheaper as well. I know the FDA doesn’t care, it is about money with them. What agency does care anymore….remember 911 and all the toxic material in the air. Everyone was told it was safe!! It doesn’t take a Rocket Scientist to know something like that is very dangerous. I have lost faith in all agencies that have anything to do with over-the-counter drugs. I don’t like to take prescriptions either. But one has to deal with pain and other things that can be a risk to their health. How many times has a drug been pulled when it has been found to be dangerous to a person’s health. One I am personally acquainted with is Actos. It causes bladder cancer. I do take herbs without any side effects. Thank God for those!

  14. Jamie

    I think making it prescription only is a terrible idea. This is the only thing that has ever stopped my menstrual cramps. I already don’t get sufficient help from doctors.

  15. alison

    Stress at work can cause stroke’s and / or heart attacks. Can we all just quit work, have the gov’t drive us when traffic gets bad, and still get paid?

  16. carol

    This study may show an increase in risk but shows nothing about absolute risk. If the risk per person with preexisting cardiac disease goes up from 1% to 1.5% this is a “significant” 50% increase. The statistical risk goes from 200/10,000 to 300/10,000. If this person also has arthritis then the risk may be worth it.

    If the risk of all users of ibuprofen goes up from, say 0.1% to 0.15% then this risk is very small for an individual.

  17. Fran

    I only take ibuprofen when my body aches, usually one or two a day when needed. Acetaminophen, half a 500mg , when the ibuprofen doesn’t work. I also make ginger tea and use turmeric in my salads. I feel sorry for people that can’t get relief, what are they to do?
    I don’t think we should be treated like children by taking away OTC drugs.

  18. Mary
    United States

    I do have one question about this study, which seems to be correlational rather than causative. As described here, the research simply shows an “association” between ibuprofen use and cardiac arrest.

    To reach a conclusion that ibuprofen actually caused these problems, the researchers would need to consider the reasons why people were taking it in the first place. It’s possible that underlying inflammation or disease conditions were actually the cause of both the cardiac problems and the ibuprofen use.

    I should add that I personally stopped taking any NSAIDs other than aspirin years ago because of health concerns, so I am not defending the practice. However, people need to be very careful about drawing conclusions from research results which are actually not supported by the research design.

  19. Kate

    This is alarming to me because I, as many others do, assume that if it is sold OTC it must be harmless and while not waiting to take an Aleve for everything, took it fairly frequently for a headache, muscle ache or just having trouble sleeping.

    I had a medium stroke in November; the neurologists cannot find a definitive reason, after many tests. My eating is healthy, I exercise fairly regularly, blood pressure is very good, moderation in things… the scary part is that I don’t know how to prevent another one.

    After reading this, I am wondering if the use of ibuprofen might have been a cause? I personally will stop taking it; the risk is too great.

  20. Aerg
    South Carolina (SC)

    Are we duped into thinking drugs will take care of everything, and then out of desperation accept the pills and try not to think they all come with side effects?

    I recently weaned off Cymbalta. My entire body aches and I cannot complete a sentence. I am so tired all I can do is lie in bed. I never dreamed my body/brain were so dependent on this drug.

    It opened my eyes about accepting drugs so willingly, even though when you are desperate for help, you’ll almost try anything. Out there, there may be safer alternatives to go with. I am certainly looking into it.
    Comments appreciated.

  21. Mary

    Those of us who live with chronic pain are left with nowhere to turn. I have been on opioid pain meds for several years for a very serious back problem and terrible neuropathy. I never ask for more, I never take it during the day, I never try to get a refill before it is due. By the time I get home from work, I am truly suffering. That is when I take it. Even though I have been prudent and responsible with the opioid meds, my doctors are hassling me – doing drug tests and limiting the prescription even more. The only things that get me through the day as a functioning member of society is ibuprofen and Voltaren gel (that I purchase OTC in Canada). It is hard enough to cope when the first thing one feels upon waking and the last thing before falling asleep is pain. There is nothing, not even the opioids, that totally relieves the pain, but the ibuprofen helps enough and enables me to continue working. I have about four years until I can retire. Without something for daytime use, I honestly don’t know if I will be able to keep working. I can see people who are worse off than I just giving up and ending it all.

  22. LM

    Can’t/Won’t take opioids, now can’t take NSAIDS — just WHAT is one to do for spinal degeneration?

    • Beverly

      Please give thought to trying Cannabidiol Oil from hemp for pain relief, otherwise known as CBD Oil. It is legal in all states since there is no THC. It has helped with my chronic pain immensely. I take 1 15mg. CBD oil every other day after an initial loading dose of 25 mg. for a week. But it is different for each person. Cell salts also have helped.

    • Steve

      Yes, those of us in severe chronic pain are in a real bind. You’d think that safe and effective pain control would have been modern medicine’s focus and triumph but that hasn’t been so. I reluctantly take a lot of Tramadol and Acetaminophen, which supposedly potentiates it, but the Graedons have noted the significant dangers of that also. Opiates don’t work for me and every day is hell even on these meds and there aren’t any others. The medical and pharmaceutical establishments have failed those in chronic pain and caused millions to remain suffering.

  23. Maria R.
    Westchester, New York

    As with any medication, one should be VERY aware of the side effects and watch for any. The problems arise when people overuse medication to relieve pain. This particular medication does relieve better than other OTC medication but you have to follow the suggested dosage and not double or triple the amount to speed up soothing of pain. Maybe having to get this medication at counter may help people to understand misuse.

  24. Nuni

    This is very interesting especially since in the late 1900’s my cardio nurse told me the only safe pain reliever for anyone with a heart condition was Ibuprofen! She said never to take Tylenol.
    Fortunately I have no need of pain relievers.

  25. Greg Pharmacist
    Toledo, OH

    I friend of mine recently ended up in the hospital with ulcers up and down his esophagus from taking high doses of OTC nsaids over several months.

    Some doctors question if NSAIDS might do damage to cartilage and stop healing over time.

    Unfortunately Rx to OTC moves are usually done to make money and are not in the best interest of the public.

  26. John

    You mention Diclofenac, but I saw no info on what it is or a brand name. I’ve never heard of it, and if it is a risk, you should include some info.


    • Mary

      Voltaren is the brand name for diclofenac.

  27. F Mayes

    I took Advil or prescription Ibufroen for years because it was the ONLY medication that stopped a migraine or my excruciating meunstral cramps. I was never aware of any side effects; however, my gastroenterologist is convinced it was the cause of my eventual microscopic colitis.

    Occasionally I still risk one dosage of 2 pills when I am in any pain caused by inflammation (e.g., bursitis) because it is so effective. If Ibufrofen is indeed taken off the market (and it probably should be) my profound hope is that something equally effective will be found to replace it.

    I do have one question: I have noticed some TV ads for an Advil patch. Does this carry with it the same risks as the pills taken by mouth?

    • Rick

      Diclofenac or Voltaren is the NSAID that killed many of the cattle in India. When the buzzards ate the carrion they died as well probably from heart attack.

      I tried it once. After 3 doses my BP hit 245/110. The same thing happened with indomethacin as well as naproxen. As far as tramadol is concerned, it caused my serotonin syndrome and I was told by my Doctor that I was hyper sensitive to all medications. I wonder if he tells that to his dead patients

  28. Lida

    Are there any safe alternatives to reduce pain when needed? I was told to take aspirin to reduce my chances of heart attack or stroke but after using for awhile it caused stomach inflammation and triggered diverticulitis which I had succeeded keeping in check. Tylenol does nothing to reduce headache pain or pain in other areas.

  29. Jane
    Eire, PA

    I don’t believe in banning NSAIDs or making them Rx only. People need to read, learn, and take responsibility for what they put in their mouths! I am celiac and not asking for a ban on gluten. Get a grip. I am sick of Big Brother telling us what we can and cannot take! Opioids are a totally different matter, for another discussion. But banning NSAIDs is ridiculous! Get educated, people!

    • Meg

      I agree that people should know the warnings. Advil is the only relief that works for me when I exercise hard and have muscle pain. I know touse small doses only for the time I need. I don’t think
      I should to take off to see a doctor to get a prescription for Advil. I will need to experiment with otc and supplements. Many have side effects, which may be debilitating. When they did that with sudafed I needed to experiment with other otc options for allergies.

  30. angie
    portland oregon

    Ibuprofen is the only pain medication that works to stop an absolutely debilitating pain that I get. Thankfully it does not occur all of the time but when it hits Advil works. I have tried aspirin and Tylenol, neither works. I don’t know what I would do without it. I am so grateful it’s available to me.

    • Bev
      Denton, TX

      Dear Angie,

      I appreciate your comment. What makes you think the people using the medication are not informed? Information is different that the ability to take action on what you know. Especially when the impact of something is insidious. When you eat gluten, you suffer immediate consequences. This is not the case with ibuprofen. Beyond getting educated, do you have any other positive recommendations for the relieving the kind of pain most people on this thread have been talking about?

      Please try to imagine the pain of others.

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