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Really Bad News About Ibuprofen, Naproxen and Other NSAIDs

People in pain do NOT want to hear bad news about ibuprofen, naproxen or other NSAIDs. To take such drugs safely, people must know the risks!
Really Bad News About Ibuprofen, Naproxen and Other NSAIDs
Alameda CA – October 16 2017: Store shelf with over the counter (OTC) pain relief products. The most common types of OTC pain medicines are acetaminophen and nonsteroidal anti-inflammatory

People who are hurting are in a tough situation. Whether they’re suffering from a bad back, arthritis, headaches, nerve pain or fibromyalgia, there aren’t many medications that are effective. Doctors often recommend nonsteroidal anti-inflammatory drugs (NSAIDs). When such medications were available only by prescription, drugs like ibuprofen (Motrin) and naproxen (Anaprox, Naprosyn) were taken by millions of people on a regular basis. Now, OTC pain relievers like Advil, Aleve and Motrin IB are household names. Sadly, familiarity may lead to lack of caution by doctors and patients. There is growing bad news about ibuprofen, naproxen and other NSAIDs. This reader had a very close call with the Grim Reaper.

When Bad News About Ibuprofen and Naproxen Becomes Personal:

“Naproxen almost killed me. After three doctor visits and two ER visits for shortness of breath and leg pain, I was finally diagnosed with severe anemia from internal bleeding. In addition, I had deep vein thrombosis (DVT) in my leg and pulmonary embolisms (PEs) in both lungs. This all occurred within the last four months, with the life-threatening pulmonary embolism about six weeks ago.

“The ER doc who saved my life immediately took me off the naproxen. I’d been taking it twice a day for the past three or so years for osteoarthritis and degenerative disc disease in my back. I loved the fact that it eased the pain and I experienced no side effects that I was aware of. I had no stomach discomfort and no idea I had an ulcer.

“None of my doctors ever suggested that I should only be on it a short time in spite of other risk factors and drug interactions. Actually, if they had, I would have resisted because it works so well.

“The three doctors who missed the PE were treating me for worsening asthma and prescribing stronger asthma meds. (My heart was tested and is fine.) The leg pain and my pointing out that the affected leg was swelling more than the other were discounted and ignored. I am grateful to have lived to make it to the ER and survived the crisis. People were praying for me, for which I am also very grateful.

“Six weeks later, I am slowly getting stronger, but I’m only able to work a couple of hours three days a week. Even that exhausts me. However, for several weeks I couldn’t work at all, so this is a big improvement.

“I’m now on a blood thinner, iron and B-12 shots. My leg still hurts sometimes. My doctor says the valves in my leg are damaged and not pumping the blood back up very well. I’m hoping that will improve and I’ll have no lasting effects from this.

“My breathing is much better, but only time will tell if I have permanent lung damage. My pain level is actually pretty good without pain meds, but I’m not using my joints or back normally yet. (It is ironic that the meds we take for pain might actually cause more pain.)

“I am so glad to have lived through it and be recuperating well. But the damage due to the drug was a life changer at least for several months. I am left with big medical bills in spite of insurance and vastly reduced income with which to pay them.

“Due to lack of early symptoms, I can understand it all being missed and ignored, but I sure do wish someone had caught it before it got so serious. Please, all of you taking NSAIDS, take these risks seriously even if you think all is well.”

NSAIDs: Bleeding and Blood Clots Can Be Deadly

The reader who shared this tale of woe and intrigue was suffering from two classic complications from NSAIDs. On the one hand, the naproxen was causing internal bleeding. This was brought on by a serious gastric ulcer.

It probably comes as a shock to learn that anemia may be the first sign of such a problem. Not everyone experiences heartburn or abdominal pain from drugs like celecoxib, diclofenac, ibuprofen, meloxicam or naproxen. The first sign of trouble can be a low hemoglobin level on a blood test. 

NSAIDs can also cause bleeding in the small intestines (BMC Gastroenterology, June 8, 2020). That is even more difficult to diagnose  because it is hard to see that part of the body.  

The second potentially life-threatening adverse reaction for this patient was blood clots. When blood clots (thromboses) form in the veins of the leg, doctors call the condition deep vein thrombosis (DVT). If the clots break loose and travel to the lungs the problem becomes pulmonary embolisms (PEs). These can be fatal. 

There is surprisingly little information about the number of people who develop DVTs or PEs in the U.S. each year. After combing the medical literature, we discovered that anywhere from 100,000 to 200,000 people die annually from lethal blood clots in veins.

One review states that (Clinics in Chest Medicine, Dec. 2010):

“The number and proportion of hospitalized patients with PE is increasing. As many as 25% may die before admission.” 

NSAIDs and Myocardial Infarction (Heart Attack):

There is more bad news about ibuprofen, naproxen, celecoxib (Celebrex), meloxicam and other NSAIDs. It has some people concerned. That’s because studies confirm an increased risk for heart attacks.

The evidence has been building for years that NSAIDs are bad for the cardiovascular system. Epidemiological studies have suggested that such drugs increase the risk for heart attacks, strokes, congestive heart failure and death. Here is a link to an article we wrote several years ago documenting these problems.

Popular Pain Relievers Trigger Heart Attacks!

Despite prior research, many health professionals and patients are reluctant to accept the bad news about ibuprofen, naproxen, celecoxib, diclofenac, meloxicam, or other NSAIDs. There have been concerns about the quality of the studies. Some experts characterized the data as “imprecise” or “inconclusive.”

Canadian and European researchers published an important article in the BMJ (May 9, 2017). The results reaffirmed the risks of NSAIDs.

What They Did:

After reviewing 82 studies for inclusion in this meta-analysis they settled on eight that met their stringent standards. Over 400,000 subjects were part of this analysis. There were over 61,000 heart attacks in this group.

Before we translate what they found, we want you to read their words for yourself:

“Through its inclusion and exclusion criteria and the definition of exposures, this meta-analysis of individual patient data (IPD) aimed to emulate the design of a large, pragmatic randomised trial comparing the main non-steroidal anti-inflammatory drugs (NSAIDs) used in the general population. By studying 61,460 myocardial infarction [heart attack] events in real world use of NSAIDs, we found that current use of a NSAID is associated with a significantly increased risk of acute myocardial infarction. This was observed for all traditional NSAIDs, including naproxen.”

Interpreting the Bad News About Ibuprofen & Other NSAIDS:

So, how bad was it? The researchers noted that:

“NSAIDs exhibited a rapid onset of risk for myocardial infarction in the first week of use.”

That challenges the thinking of many people who assumed that it would take months of daily use to trigger this effect. Doses of ibuprofen greater than 1200 mg per day demonstrated the risk between eight and 30 days. That is higher than the standard daily dose recommended on the label of drugs like Advil or Motrin IB. The directions for Advil Tablets read:

  • “adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • “If pain or fever does not respond to 1 tablet, 2 tablets may be used.
  • “Do not exceed 6 tablets [1200 mg] in 24 hours, unless directed by a doctor.”

If someone were to take the maximal OTC ibuprofen dose he would be approaching the “high dose” considered a risk by the researchers. Many doctors prescribe substantially higher doses for people who have suffered an injury or are complaining about chronic pain.

Bad News About Ibuprofen Is Not Isolated:

The authors note that NSAIDs as a class appear to have negative cardiovascular consequences. (The exception is aspirin, which may reduce the risk for heart attacks.) The higher the dose the greater the danger.

The Risk in Relative Terms:

Here is what was uncovered in terms of relative risk for people who took different NSAIDs for a week or less:

  • Ibuprofen: a 48% increased risk of heart attack
  • Diclofenac (Voltaren): a 50% increased risk of heart attack
  • Naproxen (Aleve, diclofenac): a 53% increased risk of heart attack
  • Celecoxib (Celebrex): 24%

Absolute Risk vs. Relative Risk:

In fairness, it is important to note that relative risk is almost always a scary number. A 50% increase in the risk of heart attack seems huge. And yet the absolute risk of suffering a heart attack is actually quite small. That’s because relatively few people will experience a heart attack in the first place.

We understand the the distinction between absolute risk or absolute benefit can be confusing. The pharmaceutical industry has learned how to take advantage of this complexity.

For example, the maker of Lipitor (atorvastatin) used to state that this cholesterol-lowering drug was valuable:

“In patients with multiple risk factors for heart disease, LIPITOR REDUCES RISK OF HEART ATTACK BY 36%*…”

That seems like an impressive number. Some people might assume that more than a third of patients on Lipitor could avoid a heart attack.

But the asterisk (*) in the ads told something quite different:

“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

So there was roughly one fewer heart attack out of 100 people taking Lipitor. And yes, that was a 36% relative risk reduction.

The same thing is true about the absolute risk of experiencing a heart attack on ibuprofen or related NSAIDs. Even a 50% increased risk is still a relatively small absolute increased risk. Nevertheless, we do think this is a serious cardiovascular complication of NSAIDs.

Here is what the BMJ authors concluded:

“This patient level meta-analysis of acute myocardial infarction associated with NSAIDs involving 61 460 cases in 446 763 individuals is the largest investigation of its type, and its real world origin helps ensure that findings are broadly generalisable.

“In summary, compared with non-use of NSAIDs in the preceding year, we documented that current use of all studied NSAIDs, including naproxen, was associated with an increased risk of acute myocardial infarction…Given that the onset of risk of acute myocardial infarction occurred in the first week and appeared greatest in the first month of treatment with higher doses, prescribers should consider weighing the risks and benefits of NSAIDs before instituting treatment, particularly for higher doses.”

Other NSAID Side Effects:

  • Digestive tract upset, stomach pain, nausea, bleeding ulcers, perforated ulcers
  • Heart attack, stroke, cardiac arrest
  • Irregular heart rhythms (A-fib)
  • Fluid retention, Heart failure
  • High blood pressure
  • Dizziness, unsteadiness, spaciness
  • Kidney damage, liver damage,
  • Skin rash and other dermatological reactions
  • Ringing in the ears
  • Asthma, breathing problems, allergic reactions
  • Changes in vision

People Love NSAIDs! Many Do NOT Want to Hear Bad News About Ibuprofen, Naproxen or Other Pain Relievers:

People in pain want relief, even if NSAIDs are not all that great at providing it. There just aren’t very many other options. Scary headlines about the opioid epidemic have scared physicians and patients away from such drugs, even when they may be helpful in situations of severe pain.

Here are some stories from readers to demonstrate the quandary:

Janet says bad news about ibuprofen, naproxen, etc. does not worry her:

“Every single person in the world takes NSAIDS at one time or another in different quantities depending on their pain. The FDA would pull them all off the OTC shelves if they killed in such large quantities. You’d have to sign for them like narcotics. If PP had their way, there would be NO OTC drugs because all of them have been under attack. These are scare tactics that hurt sick and desperate people.”

Ron is not concerned either:

“I have survived cancer six times so a heart attack doesn’t sound that bad to me, unless of course someone has found a way to live forever. I’ll continue to take ibuprofen.”

Anonymous in California points out:

“I would like to see the risks expressed in a different way. For example, if my risk of dying of cardiac arrest is one in 100 if I don’t take ibuprofen But instead live with daily pain, and it goes up to two in 100 if I do take ibuprofen, then I will probably take ibuprofen to be pain free.”

Some people are concerned about drug risks, however.

Hephzivah in Nottinghamshire:

“My brother took diclofenac for 6 months. Previously he had a full check up including kidneys, which were fine. His doctor prescribed the drug with no advice. There was no warning relating to to kidneys on paperwork which came with it. After 6 months use his kidney function had reduced to 25%.”

Kate offers an interesting comment on OTC drugs:

“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 wanting 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 an NSAID might have been a cause? I personally will stop taking it; the risk is too great.”

Alternatives for Arthritis:

People with arthritis must live with chronic pain. It rarely disappears in a week or two. Most patients will have to cope for the rest of their lives. Finding alternatives to NSAIDs can sometimes make a big difference in the quality of life.

We have written in depth about topical NSAIDs, home remedies like tart cherries, Knox Gelatin, pineapple, Certo and grape juice, and herbs such as Ashwagandha, boswelia, turmeric, ginger and stinging nettle. There is also acupuncture. To learn more, here is a link to this online resource, Alternatives for Arthritis, in our store. If you prefer to hold a book in your hands, we have converted this electronic version into a paperback at this link

You may also find our book, Top Screwups Doctors Make and How to Prevent Them of value. In it we discuss the serious problem of diagnostic mistakes. You might be surprised to learn how often DVTs and pulmonary embolisms are misdiagnosed. This is personal for me. My uncle almost died because of PEs that went undiagnosed. The story is in the book. We provide tips on how to reduce your risks of a misdiagnosis. You should be able to find the book in your local library or in our bookstore

Share your own experience with NSAIDs below in the comment section. Many readers have been very candid about their own experiences, both positive and negative. Have you found alternatives to NSAIDs that ease inflammation or pain? Share your story with others and please vote on the article at the top of the page if you found any of this information helpful. If you know someone who takes NSAIDs for pain, you may wish to send it via email, Twitter or Facebook using one of the icons at the top of the page. 

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
Citations
  • Stein, P.D. and Matta, F., "Epidemiology and incidence: the scope of the problem and risk factors for development of venous thromboembolism," Clinics in Chest Medicine, Dec. 2010, DOI: 10.1016/j.ccm.2010.07.001
  • Bally, M., et al, "Risk of acute myocardial infarction with NSAIDs in real world use: bayesian meta-analysis of individual patient data," BMJ, May 9, 2017, doi: https://doi.org/10.1136/bmj.j1909
  • Lim, D-H, et al, "Non-steroidal anti-inflammatory drug-induced enteropathy as a major risk factor for small bowel bleeding: a retrospective study," BMC Gastroenterology, June 8, 2020, doi: 10.1186/s12876-020-01329-5
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