Ibuprofen bottle, triggers atrial fibrillation

Do you read the labels on OTC pain relievers? Be honest now. The last time you purchased Advil, Motrin IB or some house brand ibuprofen pills, did you check out the dosage instructions or the warnings on the label? Do you know what ibuprofen side effects you should be watching for? Even if you read the label on OTC nonsteroidal anti-inflammatory (NSAID) products you may not be informed of all the potential serious complications.

Ibuprofen Side Effects:

  • Heartburn, abdominal pain, nausea, vomiting
  • Ulcers, bleeding ulcers, perforated ulcers
  • Headache, dizziness, drowsiness, disorientation
  • Skin rash, sensitivity to sunlight, itching
  • Fluid retention, high blood pressure
  • Heart failure, heart attack, stroke
  • Irregular heart rhythms (AFib)
  • Ringing in ears, hearing changes
  • Visual disturbances
  • Liver damage, kidney damage

Overdosing on NSAIDs:

A new study suggests that many people exceed the daily limit of OTC ibuprofen (Pharmacoepidemiology & Drug Safety, Jan. 26, 2018). They may also take two different NSAIDs during the same day, without realizing it.

Someone might be relying on Motrin IB for a backache during the day and Aleve PM to get to sleep at night. The Motrin IB contains ibuprofen and the Aleve contains naproxen. Both are NSAIDs.

Another example: someone may be taking Advil for a headache and also taking Dristan Sinus for nasal congestion. The two products contain ibuprofen, so it would be like doubling the dose. That could also lead to an increased risk of ibuprofen side effects.

NSAID Dosing Confusion:

We found one especially intriguing aspect to the new study. Most people assume that the proper dose of OTC pain relievers is 2 pills. That’s presumably because they are used to taking two Tylenols, two aspirin tablets or two ibuprofen pills at a time. It turns out that some of the cold, flu and allergy meds that contain ibuprofen suggest 1 pill dosing. And the instructions on the label of Aleve are different from the dosing recommendations for Advil.

Aleve Dosing Directions:

“What are the daily and maximum doses for adults?

“Take one tablet, caplet, gelcap or liquid gel every 8 to 12 hours while symptoms last. For the first dose, you may take 2 pills within the first hour.

“Do not exceed more than 2 tablets, caplets, gelcaps or liquid gels in 12 hours, and do not exceed 3 tablets, caplets, gelcaps or liquid gels in 24 hours. The smallest effective dose should be used. Drink a full glass of water with each dose.

“Do not take for more than 10 consecutive days for pain or 3 days for fever, unless directed by a doctor”

Advil Dosing Directions:

“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 in 24 hours, unless directed by a doctor”

If someone were to take Aleve the way they take Advil (up to 6 pills a day) they would be doubling the daily limit and increasing the risk for adverse reactions.

Ibuprofen: The Most Popular NSAID in the Pharmacy

Americans are in a LOT of pain. That’s why the number one drug in the U.S. is acetaminophen (Tylenol). According to the latest Pharmacoepidemiology & Drug Safety study: ibuprofen

“…is the second or third most‐commonly‐used drug in the US after acetaminophen, and the most‐commonly‐used non‐aspirin NSAID.

“While NSAIDs are effective for their intended purposes, they also have considerable side effects which are generally dose related and can be fatal, including major upper gastrointestinal bleeding, acute renal injury, and cardiovascular outcomes such as myocardial infarction and stroke.”

Not Reading the Label:

Many people who use nonprescription drugs don’t read the label carefully. They may assume that if the FDA saw fit to make a drug available without a prescription then it must be quite safe.

The new study of 1,326 people found that 15 percent of them took more than the maximum recommended dose. The volunteers all filled out online medication diaries every day for a week. All of them used ibuprofen during the week, with 87 percent of them taking the drug without a prescription.

More than half of them took it at least three days a week, with 16 percent taking it every day. More than one-third of them took another drug in the same class. Most of the time that was aspirin or naproxen, and few of the participants realized that they were taking more than one NSAID.

Foreign Experts Weigh in on NSAIDs:

Dr. Gunnar Gislason is director of research for the Danish Heart Foundation in Cophenhagen. He told Reuters:

“I believe that the message sent to the consumer when these drugs are widely available in convenience stores and gas stations is that these drugs are safe and you can use them safely for pain relief – thus no need for reading the label.”

Dr. Liffert Vogt is associated with the Academic Medical Center at the University of Amsterdam in the Netherlands. Neither he nor Dr. Gislason were involved in the NSAID study. Dr. Vogt told Reuters:

“In my opinion NSAIDs should not be available as an over-the-counter drug, because of all their deleterious effects.”

Should the FDA Limit OTC Use of NSAIDs Like Ibuprofen or Naproxen?

We posed that question almost a year ago in this article. The outcry was immediate and intense. People want access to OTC ibuprofen and naproxen no matter what. Many said ibuprofen side effects are not an issue for them.

Angie in Portland, Oregon loves ibuprofen:

“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.”

Jane in Erie, PA is outraged with the idea of limiting OTC NSAIDs:

“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 have celiac disease and I am 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 over-the-counter NSAIDs is ridiculous! Get educated, people!”

Klara in Atlanta agrees with Jane:

“I agree with Jane from Erie, PA. LEAVE IBUPROFEN ALONE! I don’t take NSAIDs on a regular basis, but I keep them around for occasional aches and muscle pain and they’re wonderful. I hate it when Big Brother takes a perfectly good OTC medicine away from us or makes us go through gatekeepers to get it. Don’t patronize us! Let everyone decide for himself whether to take it or not.”

Thai has come up with a suggestion that we have long supported:

“I think a middle ground might be the best way to allow purchase of ibuprofen and naproxen. It should be available without having to make a doctor’s appointment. That causes unnecessary expense and limits 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.”

This is called “behind the counter” access. Many other countries have this 3rd category for medications. We even have it in the U.S. for the decongestant pseudoephedrine. That’s because public health officials worry that this drug can be turned into methamphetamine. By requiring the pharmacist to keep track and counsel patients it has presumably limited the amount of illicit meth that is “cooked” in the U.S.

The Down Side of OTC NSAIDs:

Kate suffered a stroke after taking NSAIDs:

“This is alarming to me. I, as many others, assume that if it is sold OTC it must be harmless. I took Aleve 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. My blood pressure is very good. I exercise 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 an NSAID might have been a cause.”

Greg the Pharmacist in Toledo, Ohio shared this story:

“A 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.”

Patty reinforces the message of the new study published in Pharmacoepidemiology & Drug Safety:

“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.”

Deborah in North Carolina also had a stroke:

“I just had a stroke with no risk factors for stroke in family or myself. Of Course, I am on HRT and have been on it since my forties. I had started taking ibuprofen at night to help with sleep when the stroke happened.

“All work ups and tests after the stroke show no risk factors except, of course, maybe from the hormones and of course the ibuprofen. I had one in my sleep without knowing it and had taken an ibuprofen that night.”

Ibuprofen Side Effects: Plausible Denial

People who sell NSAIDs are likely react to a story like Deborah’s with disbelief. They could easily insist that the hormones were responsible. Or her age was the determining factor. It is almost impossible to prove that any given individual experienced a stroke, a heart attack or cardiac arrest because of an NSAID. Ditto for kidney damage or atrial fibrillation. On the other hand, gastroenterologists often link stomach ulcers to drugs like ibuprofen or naproxen without a moment’s hesitation.

People’s Pharmacy Perspective:

We are not advocating that the FDA ban ibuprofen or naproxen. We would like to see these drugs continue to be sold without a prescription. But we would like them sold behind the counter with a pharmacist’s consultation rather than in convenience stores or super markets.

That way people could be warned about symptoms to be alert for and drug interactions that could be dangerous. Doctors who prescribe NSAIDs like celecoxib, diclofenac or meloxicam get detailed warning information about heart attacks, strokes, gastrointestinal bleeding, ulceration and perforation, liver toxicity, hypertension, heart failure, kidney toxicity and serious skin reactions. They are told to:

“Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately.”

Lida is seeking alternatives to acetaminophen and NSAIDS:

“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 it for awhile it caused stomach inflammation and triggered diverticulitis which I had been keeping in check. Tylenol does nothing to reduce headache pain or pain in other areas.”

In our book, Graedons’ Guide to Alternatives for Arthritis, we offer a variety of non drug options to control pain and inflammation. They include herbs such as ashwagandha, boswellia, turmeric (curcumin), ginger and stinging nettle. There is information on pineapple (bromelain), gelatin and dietary supplements like MSM and SAMe. You can learn much more about these NSAID alternatives and favorite home remedies at this link.

Share your own story about the pros and cons of NSAIDs. Have you ever noticed ibuprofen side effects? Others can benefit from your experience in the comment section below.

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  1. Trish
    Seattle
    Reply

    Diverticulitis and NSAID: I am very fit, healthy, normal BP, normal weight. I work out strenuously five days a week and recently began to experience shoulder pain. I started taking ibuprofen last week. Everyday, 2 pills, every four to six hours.

    Two days ago I had a very painful attack of diverticulitis. I was close to heading to the emergency room; it lasted for two days. Ironically, the only thing that helped me feel more comfortable was ibuprofen but my research showed that these pain killers actually can cause an attack of diverticulitis and have since read a published study (ncbi.nlm.nih.gov) and won’t take them unless extremely necessary. Acute diverticulitis can cause internal bleeding, lead to removal of part of the colon and more.

  2. Pat M
    CALIF
    Reply

    I think even when you read the instructions carefully and follow them, you can still develop problems. I was taking sodium naproxen for arthritis on a 1 X daily basis and developed bleeding in my stomach. Scared the heck out of me when I had a BM and out came bright red blood. My Dr. said it’s more common then you would think.

  3. Mary
    Ohio
    Reply

    I noticed if I take two (200 mg) of ibuprofen each night, I sleep well and do not have leg cramps.

    If I also take two (200 mg) of ibuprofen in morning before going to work, I do not have to stop every hour to go to bathroom because of drinking tea and coffee.

  4. Susan
    Iowa
    Reply

    My husband hurt his shoulder trying to get rid of a beaver dam. He used ibuprofen thinking it was a safe pain medication even at unrecommended doses. Long story short he ended up being hospitalized and almost died due to hepatic encephalopathy and gastric ulcer. The scary truth is ibuprofen is not safe if taken in larger doses, or even every day at recommended doses. My sister had increased liver enzymes from taking doses at recommended levels.

  5. Linda
    WV
    Reply

    I was so glad to see your article on the side effects of ibuprofen as it confirmed what I had been thinking. Several years ago while still working as an RN, I was having trouble hearing. This made phone calls a nightmare. When I was tested I had an 80% hearing lose in some of the higher frequencies! I also had ringing in my ears. Many years a go I had had a great deal of pain in my neck and shoulders ( mostly due to my posture …locking my Knees ) I was taking 800 mg of ibuprofen 3 to 4 times a day for pain! even though I corrected my posture and stopped the ibuprofen, I believe this was a major factor in my later hearing problems which i was told were similar to someone who had experienced war combat! Thanks for the info.

  6. Virginia P.
    Asheboro, NC
    Reply

    I agree that people should be responsible – not the pharmacist. I had a doctor tell me to use Ibuprofen for a female bleeding disorder which confused the life out of me. But after checking into it, I found that what he had said was valid. More than that I use ibuprofen on a regular basis for pain, but I also read all packages when I use something else like cold medicine and adjust accordingly. With as much OTC pain relievers sold, and it would eventually apply to all, wouldn’t the pharmacies have to hire someone specifically to handle OTC pain relievers? It’s bad enough to have to stand in line for some OTC medications already. How many times would I have to have this instruction?

  7. christine
    pittsburgh,pa
    Reply

    my doctor had me taking motrin for years,post a car accident that damaged both my knees. t no doctor wanted to give me even a low dose of percocet for chronic pain. so i was taking motrin for 20 years for chronic pain,eventually because my doctor advised me to up my dosage from 2 pills every 6 hours to 3 every six hours,i developed an arrythmia in 2015 and had a mild stroke from which i have fully recovered. however when i realized what caused the stroke,the doctors at the hospital did not believe me. insisted it was what they said. i have chronic knees pain from torn meniscus in both knees,a torn rotator cuff,and no doctor wants to prescribe me with a low dose of a narcotic to help me. in fact they gave me more motrin in the hospital! i advise everyone to stay away from motrin now.

  8. Sam T
    Williamsburg, VA
    Reply

    My wife has serious pain in her knees and Legs. One doctor told her it would be O K to take 4 advil every night, because that is the prescription strength when given for pain. Should she continue? But she does need some pain relief.

  9. John M.
    Downey, California
    Reply

    4-5 years ago my wife walked into the bedroom complaining that the palms of her hands were itching & tingling like mad. She said she’d just taken an Aleve. I immediately handed her a Benadryl & water which she took. As I was in the kitchen trying to read the microscopic fine print on the Aleve bottle, she collapsed face-first onto our hardwood floor. When paramedics arrived, they took one look at my wife lying on the floor with a bloody face and were highly skeptical about my explanation. They asked her repeatedly what had happened before rushing her to the hospital. My wife eventually recovered but not before the ER doctor confided to me that she had suffered anaphylactic shock and that the Benadryl had very likely saved her life. All this from one Aleve (which is no longer in our cupboard!). Now when she needs pain relief, it’s a Bufferin.

  10. Ellen C
    Dallas, Texas
    Reply

    I think that both Tylenol and its generic counterpart plus Motrin and other NSAIDS should have a very large print, brief, and clear warning on the box or bottle plus the requirement for a consultation with the pharmacist before it can be paid for,. It is essential that all of us read all of the directions and warnings on OTC medications and vitamin and herbal offerings., Many people’s unwillingness or inability to read and follow the instructions for safety when using these medications create problems for the rest of us who are careful and pay attention to the dosages and warnings.

  11. Carol
    Seattle
    Reply

    I was taking a lot of ibuprophen daily for a number of years for relief from VERY ankle ulcers that were a result of varicose veins. I had recurring ulcers for 20 years until I was FINALLY referred to a vascular surgeon who said he could help me, and he did. No ulcers for nearly a year now. I just had an endoscopy (and colonoscopy) and learned I have esophagus ulcers and stomach ulcers. I would’ve thought there would be more symptoms other than some heart burn, but since then I’ve read that 3/4 th of patients with stomach ulcers don’t have symptoms. Yes, I knew I was using too much ibuprophen, but two thoughts about that: 1- supposedly OTC ibuprophen isn’t as strong as prescription ibuprophen, so I felt that taking more was equivalent to Rx ibuprophen; and 2- when you’re in so much debilitating pain and still have to function, and vascular surgeons are telling you there’s nothing they can do for you (until you finally find one who can help), and this goes on for twenty years, how do you deal with so much pain??? Now they want to take hydrocodone away, which was very helpful but I never got addicted to, and now all this talk about NSAIDS too. If pharmacists were required to educate the patient (I can imagine that would be a time-grabber for them since NSAIDS are so widely used) and yet the patient may have no symptoms of STM’s h ulcers, or stroke, etc, but they DO have debilitating pain for years on end, then how is that going to be addressed??? Go to heroin? Please please give us some help!!!

  12. Astrid
    Winter Park, FL
    Reply

    Why is it that no one mentions BUFFERIN which is buffered with magnesium carbonate, calcium carbonate and magnesium oxide, which is the type that was used in hundreds of studies on aspirin.
    Please search for the article “Aspirin Therapy Revisited” in your search engine.
    I can for some reason no longer find this product at Walgreens nor another local pharmacy. Keep searching.
    Under drug facts on the package, it is written in a bright yellow box about the ingredients.
    Astrid L, Winter Park, FL

  13. Grace
    Washington state
    Reply

    Look into the emerging problem of taking the recommended low doses of one of these OTC NSAIDS and an OTC proton pump inhibitor (PPI) over years. Both the pain and the acid reflux are unrelated chronic conditions that don’t disappear, but can be effectively controlled OTC. After many years (5 or more) … one ends up with a ‘new’ kind of colitis … ‘microscopic’ or ‘immunologic’ colitis. There are probably a lot of us who will develop this in the next decade. At this point, the PPI is absolutely necessary to me, but chronic pain now only can have low dose aspirin or acetaminophen. Neither of those work as well as the NSAIDS like ibuprofen or naproxen, but there you are! We have a new disease condition emerging from the situation.

  14. Kathi
    Austin, TX
    Reply

    Many years ago, while working at a local hospital, I learned of a woman who got food poisoning at a restaurant. She became very dehydrated from vomiting and diarrhea. She took ibuprofen and ended up on dialysis due to the damage it did to her kidneys. The few times I’ve taken ibuprofen I always make sure I drink plenty of liquids.

  15. Patricia
    NC
    Reply

    After a molar extraction the oral surgeon’s written instructions advised rather than a common opioid to take 1 ibuprofen 200 and 1 acetaminophen 500 together if needed every 6 hours. One dose twice a day for me was perfect for 2 days only.

  16. Theresa
    Texas
    Reply

    NSAIDs – perhaps an answer to overdosing can come with the return of low dose availability. I always seek low dose in pain relievers, yet almost every product on the market is labeled extra strength. This makes for dangerous outcomes.

    • Carol
      Reply

      Sorry, I should’ve proof read my text before posting. I meant to say, very PAINFUL ankle ulcers, and no SYMPTOMS of stomach ulcers or stroke, etc.

  17. Kathy
    Texas
    Reply

    I believe that NSAIDS is a wonder drug. I asked my sister, a Pharmacist, how much I could take and she said no more then 12 per day. It has not caused me any side effects because I always take them with a lot of water and with food. It controls my pain better then Hydrocodone from bilateral knee replacement and regional pain syndrome and all the drugs my Pain Doctor prescribes for me.

  18. Helen
    Reply

    A few years ago, I had emergency surgery for a ruptured appendix, followed by a 6 day hospital stay. Several drainage tubes were placed. I wasn’t allowed to eat or even sip water–just suck on a wet sponge. Obviously, they were pumping IVs into me very quickly, so I certainly wasn’t at all dehydrated. I actually felt good, just a little tired.

    A week or so after getting home from the hospital, I developed a very painful feeling in my upper stomach/chest and thought it was a heart attack. Long story short, it was gastritis. These painful bouts happened a few times. I might also add it took many months of careful eating before my stomach felt somewhat normal again.

    Evidently, the naproxen I was taking post surgery (and I’m one who dislikes meds and takes as little as possible) caused this. It makes me wonder if naproxen was in the IV fluids I received in the hospital. I have no idea, but have always suspected that, since, as I said, I rarely take pain meds unless the pain is super bad. I don’t know what else would cause stomach erosion. My gastro doctor suspected the naproxen.

    Might be something to monitor if you’re ever in the same situation. Don’t be afraid to ask if they are putting lots of NSAIDS into your body via IVs without your knowing it.

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