Non-steroidals carry increased risk for heart attacks, strokes and death

The FDA will be requiring manufacturers of non-steroidal anti-inflammatory drugs (NSAIDs) to add additional warnings to their products. Studies over the last few years have shown that NSAID use carries an increased risk for heart attacks, heart failure and strokes.

NSAIDs are potent anti-inflammatory drugs. Some are COX (cyclooxyrgenase)-2 inhibitors, meaning that when the NSAID interacts with COX-2 it prevents or decreases inflammation and leads to decreased pain.

Since their introduction, years ago, they’ve become a quick go-to pill for pain relief. Some are available over the counter, like Motrin (ibuprofen) and naproxen (Aleve, Naprosyn), while others require a prescription, like celecoxib (Celebrex). A list of NSAIDs can be found here.

While acetominophen (Tylenol) has mild NSAID-like effects, it usually isn’t classified as a non-steroidal. Aspirin is classed as an NSAID, but the FDA says that there is no increase in risk for cardiac or vascular events with aspirin other than those already known. Additionally, there numerous studies showing that aspirin can decrease the incidence of heart attacks.

Many people use them for a variety of reasons: athletic injuries, home or work injuries, low back pain, headaches, painful menstruation, arthritis and dozens of other uses. Doctors frequently prescribe them for pain relief for pain at the mild-to-moderate level, as well as for their anti-inflammatory properties.

But from early on there were known and often severe side effects associated with non-steroidals, including ulcers that caused severe stomach pain that could be coupled with bleeding from the gastrointestinal tract. Other NSAID users suffered excessive bleeding after trauma or post-operatively unless usage was stopped prior to the event.

But most worrisome were the cardiovascular effects that could happen to patients taking NSAIDs — primarily heart attacks and strokes.

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Remember rofecoxib (Vioxx)? Maybe you don’t, because its manufacturer withdrew it over concerns that it caused an increased risk of heart attacks and strokes. Rofecoxib was marketed to treat dysmenorrhea (painful menstruation, pain and arthritis), and it was estimated that about 100,000 people may have had some kind of cardiac event due to using it. Its manufacturer faced a heavy lawsuit, which you can read about here.

Valdecoxib (Bextra), a similar NSAID, was banned in the United States for similar reasons.

Based on data from post-marketing studies, the FDA required that NSAIDs carry a warning stating that there could be an increased risk of cardiovascular events, strokes and deaths from using NSAIDs.

Research on NSAIDs has continued and more data has accumulated, showing that they are contributing to cardiac and vascular events, including deaths. The FDA will be requiring an even more strict warning with additional information to alert users that NSAID use can be risky.

Below is a list of what the data shows from at least two recent studies and an analysis of other studies.

  • Increased risk for heart attack and/or stroke can occur with NSAID use at as early as 2 weeks after starting regular NSAID use.  This risk increases the longer the treatment continues.  The risk is higher at higher does levels.
  • NSAID use increases the risk of heart failure.
  • NSAID use increases the risk of a cardiovascular even and/or stroke even if the patient has no pre-existing cardiac or vascular disease.
  • Patients who do have pre-existing cardiovascular disease have an even higher risk of having another event than those who don’t have an increased risk.
  • Patients given NSAIDs after they had a first heart attack had a higher mortality than those who were not treated with non-steroidals.
  • It seems as if the increased risk applies to all non-steroidal drugs (see note below), but there may be a few that carry a somewhat lower risk than others.

 

If you’re taking an NSAID on a regular basis, it’s suggested that you discuss your continued use of it with your doctor in the immediate future. They may want to change to a different NSAID, reduce your dosage or switch to a different medication.

Patients who develop chest pain, shortness of breath, weakness on one side of the body, facial droop, slurred speech or any symptoms that can be attributable to a heart attack, heart failure or stroke should go to an Emergency Room immediately.


Mark Thoma, MD, is a physician who did his residency in internal medicine. Mark has a long history of social activism, and was an early technogeek, and science junkie, after evolving through his nerd phase. Favorite quote: “The most exciting phrase to hear in science... is not 'Eureka!' (I found it!) but 'That's funny.'” - Isaac Asimov

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  • Steve Teeter

    Ten years ago I nearly died of kidney failure. The doctor who put me in the hospital estimated I had no more than 30% function left. The only thing my nephrologist could figure as a cause was overprescription of an NSAID called Mobic. This was by a very bad doctor who never thought to set up a monitoring regimen to see how I was doing on the drug. Since then I have been forbidden NSAIDs absolutely.

    Obviously, I recovered.

  • Bomer

    I suffer from migraines as well and have had pretty good luck with clonidine. It’s usually prescribed for high-blood pressure but it works on migraines too (knocks you on your butt). My grandmother swears by ergotamine (at the time she was taking it you could only get it in Mexico).

  • Dorinda
  • ammy.toilor

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  • Baal

    That is a pretty negative way of putting it (doctors just want patients to go away). That is painting with too broad a brush. Perhaps a better way of putting it is to note that options to deal with pain are very few and either woefully ineffective (which is apparent when they are studied in controlled trials) or dangerous at some level (addiction, cardiovascular and GI risks, etc.). This is true for the best doctors on the planet and the worst.

  • Maziever
  • Or you might want to see a neurologist who specializes in migraines.

    I did. Had MRIs and the whole 9 yards to make sure it wasn’t some abnormality or tumor or whatever, too.

    Having tried triptans already, two of them, and having no results at all other than relatively debilitating side-effects and a large hole in my wallet, I’m not sure I see the point in continuing down that particular dead-end road.

    Trust me, Mark, I did avail myself of professional medicine…which is no doubt at all why when I was trying to sign up for individual-market health insurance in 2002-04, I was rejected over and over for the pre-existing condition of migraines (and hayfever allergies…which also, by the way, exacerbate migraine onset).

    In truth, I don’t want opiods. The few times I was prescribed them, they made me feel awful. As for pain specialists, the last thing my self-esteem needs is what I’ve witnessed too often, including one close friend with lupus, where those who need and ask for help with chronic pain are invariably treated like malingerers and suspected criminals.

    If I ever get to the point where I need serious chronic pain management, I figure my options are either (1) move to a country with a far more civilized attitude towards suffering or (2) eat a shotgun. Since I know my wife would be devastated by #2, I rather think option 1 is more likely.

  • docsterx

    Pain relief is still a concern to many doctors. But with increasing rates of drug use, drug diversion and pressure from the DEA, many doctors are wary about prescribing opioids and other medications that are often abused or resold. Some won’t prescribe any opioids for use for longer than a week or so. For those needing prolonged dosing, they’ll refer to a pain specialist.

  • docsterx

    There are a number of triptans that have come out since then. It might be worth talking to your doctor about trying one of the newer ones.
    Or you might want to see a neurologist who specializes in migraines.

  • The patient’s need for relief doesn’t seem to factor into the current environment.

    I agree completely, on both the overprescribing (which was a doctor’s way of making patients go away), but especially now on the fact that genuine pain relief often doesn’t even seem to be a concern.

  • Dopamine antagonists are contraindicated due to my prior history of chronic depression. (I’m fine in this respect now…but from a very early age up until my late 30s, depression and I were constant companions. Quite possibly exacerbated by the migraines. But given the way steroid meds, esp. prednisone, can still turn me into a suicidal rage-monster, I’m not willing to take a chance on bringing that back.)

    As for triptans, back in the late 1990s my doctor and I tried both Imitrex and Zomig, and I did not respond to either, so we gave up that route. There were also concerns about my family history of hypertension and heart disease. (Plus, at the time, my prescription med coverage was sh*t and triptans were hideously expensive, so I didn’t want to waste more money on type of meds that were likely not to work. It’s kind of a disincentive to use a med when you know that a single set of prophylactic doses is going to cost about fifty bucks and it probably won’t even work.)

  • Hue-Man

    If I walk around the block, my risk of dying is higher than if I remain huddled under my bed-covers! We all have to make risk assessments, including deciding to take NSAIDs. Without that discussion of relative risk – is it the same risk as being hit by lightning or the risk of falling in your bathroom? – I read items like this and don’t know whether I should ignore it completely or run around with my hair on fire!

    And to make sure you suffer an early death from worrying, this item from earlier this month:

    “Health Canada is considering lowering the recommended daily dose of acetaminophen following a Star investigation into the hidden dangers of the popular painkiller.” http://www.thestar.com/news/canada/2015/07/10/health-canada-takes-action-on-potential-danger-of-acetaminophen.html

    I’ll stick with my favorite: Hypochondriac’s head stone – “I told you I was sick”

  • docsterx

    Are you taking anything to prevent migraines?
    Dopamine antagonists and some triptans can be used during an attack. Some triptans are prophylactic and can be used to abort migraine attacks.

  • Hue-Man

    Doctors were complicit in the excessive over-prescribing of powerful painkillers – those prescriptions didn’t write themselves! I sense that the pendulum has swung too far the other way so that docs are presumed guilty of over-prescribing from the first prescription they write. The patient’s need for relief doesn’t seem to factor into the current environment.

  • devlzadvocate

    The new warnings should have included the previous warnings of potential gastrointestinal problems with continued NSAID use, although those warnings were somewhat vague. I found out the hard way even though my doctor kept renewing my scripts. Gastrointestinal bleeding is also an issue.

  • It’s in there — just moved it. Paragraph 4 :)

  • *sigh*

    I had occasionally been using Darvocet for migraine relief…but those were withdrawn from the market due to liver problems. Even before I could no longer get a ‘scrip for these, doctors were increasingly reluctant to write them.

    I had a medical MJ card in California, and it worked wonders when I needed it…but now I live in a state where migraines aren’t on the approved list of chronic conditions, so I’ve had to switch to Ibuprofen and occasional Excedrin Migraine formula. Which is only a partial solution. Doctors are extremely averse nowadays to prescribe pain relievers of any kind for more than very short term use. And I am simply not willing to break the law on MJ use. I’m also not willing to go to one of those pain clinics where they treat all their patients like low-life junkies, all because we Americans have this incredibly stupid social notion that it’s a character flaw not to want to endure crippling pain.

    So does this mean I and many others really have no recourse but to move to Colorado or the west coast? Because so far, MJ is the only treatment which apparently doesn’t have all of these “It will KILL you eventually!” warnings.

    Switch to another medication, eh? WHAT MEDICATION? (sorry for the shouting) Nothing seems to be less than eventually lethal when used for chronic pain treatment.

  • MoonDragon

    Thank you. Reye’s it was. I still think the ascendance of acetaminophen as the drug of choice for pain was an overreaction. Never did shit for menstrual cramps.

  • docsterx

    Guillain-Barrré usually occurs after an infection. the infections are most often of the gastrointestinal tract (e.g. Campylobacter jejuni in the stomach, causing a gastroenteritis) or respiratory tract infection.

  • docsterx

    You’re probably thinking of Reye’s syndrome. Reye’s can develop in some children who get a viral illness and are given aspirin.

  • nicho

    What? Big Pharma making billions off of things that are bad for us? Heavens to Betsy. Imagine that!

  • docsterx

    1. Some other options that could be used for pain relief (discuss with your doctor before trying them) include:

    Aspirin + acetaminophen combination drugs

    Aspirin + acetaminophen + caffeine combination drugs

    Possibly a short course of steroids (Rx)

    Other medications depending on the exact diagnosis.

    2. Right now it appears that of all NSAIDs (other than aspirin) naproxen seems to have the lowest risk of causing heart attacks and strokes. But it still does increase the risk of those things occurring.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778977/

    3. For those who are taking low-dose aspirin for its cardio-protective effects, taking NSAIDs on a regular basis with aspirin, can prevent aspirin from reducing the risk of heart attacks.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1150323/

  • Guillain-Barré Syndrome. ;-)

  • docsterx

    This NOTE should appear under the last bullet point in the list above:

    While acetominophen (Tylenol) has mild NSAID-like effects, it usually isn’t classified as a non-steroidal. Aspirin is classed as an NSAID, but the FDA says that there is no increase in risk for cardiac or vascular events with aspirin other than those already known. Additionally, there numerous studies showing that aspirin can decrease the incidence of heart attacks.

  • Mike_in_the_Tundra

    I also have arthritis that can be quite bad at times. When it acts up, I need to take Ibuprofen in the morning. Otherwise, I can’t get my day started. My doctor is definitely opposed to my taking acetaminophen. I suppose that’s because I had hepatitis a few years back. At bedtime, I find a little weed works just as well as the Ibuprofen. I just can’t use it during the day, because it also gets me high.

  • Mike_in_the_Tundra

    I thought acetaminophen was linked to Guillone-Barre as well.

  • MoonDragon

    I remember a time when aspirin was all there was. When some children developed Guillone-Barre Syndrome (?) after taking aspirin for flu symptoms, everyone panicked and went to acetaminophen. Since then doctors have been prescribing it instead of aspirin for every one for everything, quite unnecessarily. Acetaminophen has numerous downsides, including liver and kidney issues. Also, I’ve never found it to be particularly effective for me.

  • Gindy51

    A good friend of mine broke her hip and ankle and was on prescription pain meds. She’d had a history of ulcers (documented) but when her script ran out her doc said to go on NSAIDs. She had to take more of them to counter act the pain of her injuries and now she has almost no stomach left and very little intestines to boot. Sure she should have questioned the advice but she thought her doctor knew what he was doing. Apparently not….

  • Indigo

    Naproxen helps me control arthritis. I cut back when some kidney issues arose but after I cut back, those issues resolved themselves. For now, I might take 2 in the morning when the arthritis is especially severe, maybe once or twice a month. Other than that, I’m off the Naproxen. As for Tylenol, my current physician’s default suggestion for occasional pain, it makes me sick to my stomach. Yuck!

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