One of the most popular NSAIDs (nonsteroidal anti-inflammatory drugs) in the pharmacy is naproxen. It was originally only available by prescription under the name Naprosyn. Now doctors can write prescriptions for naproxen as a generic pain reliever or under the brand names Anaprox, Anaprox DS, EC-Naprosyn, Naprelan and Vimovo (which also contains the acid-suppressing drug esomeprazole).
Naproxen has also been available over the counter for years in products like Aleve, Aleve PM, Menstridol or Midol Extended Relief. There are also dozens of house brand naproxen products people can buy without medical supervision.
We fear that this NSAID as well as similar drugs (diclofenac, ibuprofen, meloxicam, etc) have a long list of serious side effects that most people are either unaware of or ignore. Kidney damage is just one complication to pay attention to as this reader notes.
Kidney Damage from Naproxen:
Q. I am a 16-year-old girl who has had bladder problems since I was eight. I was taken to the hospital for pain in my left hip and the doctor prescribed two pills (500 mg) of naproxen to be taken twice daily.
I had pain in my stomach and back and couldn’t sleep. Then my urinary system shut down completely. I had taken the drug for almost three weeks before another doctor took me off. I was in the hospital for seven weeks and was just released with no improvement.
I know the drug did this to me. Has anyone else had this severe reaction?
A. Nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen can harm the kidneys (Pharmacoepidemiology and Drug Safety, Oct., 2009). A study of marathon runners found that those who took ibuprofen before the race to ward off muscle soreness were more likely to develop temporary kidney failure as a result (BMJ Open, online April 19, 2013).
Most health professionals probably assume that seemingly healthy people, especially young adults, could not suffer worrisome kidney damage from a prescription for naproxen or ibuprofen. A meta-analysis of five studies published in the European Journal of Internal Medicine (May, 2015) suggests otherwise. The authors reported an increased relative risk of acute kidney injury (AKI) ranging from 58% to 211% among NSAID users.
In doctorspeak:
“In conclusion, a statistically significant elevated AKI risk among traditional NSAID users has been demonstrated in this meta-analysis…Clinicians must weigh the possible risks of AKI and other NSAID related adverse events, including chronic kidney injury, hypertension and gastrointestinal bleeding against their potential benefit. Where ever possible, strategies using the minimum amount of drug for the shortest duration possible are preferred over long term treatment.”
Heart Attacks, Strokes and Heart Failure:
There is growing recognition that NSAIDs can affect the cardiovascular system. Although most people do not understand heart failure very well (the failure of the heart to pump blood efficiently), the outcomes can be disastrous. NSAIDs increase the risk of heart failure and if people have this condition NSAIDs can make it substantially worse (European Journal of Internal Medicine, Nov., 2015).
An ongoing controversy in the medical community is whether some NSAIDs are more or less likely to cause heart attacks or strokes. Some studies suggest that naproxen may be a little less of a problem than some of the other pain relievers in this class. That said, the FDA has not given naproxen a green light in this matter. A study published in Current Vascular Pharmacology (July, 2016) suggested the following:
“The best safety profile related to MI [heart attack] was found for naproxen, while the worst safety profile, with excessively increased risk for stroke, MI and major bleeding, was for diclofenac. Naproxen showed higher risk for major bleeding than ibuprofen and the risk for stroke was slightly higher than ibuprofen. Regarding heart failure, ibuprofen presented the highest risk while the highest risk for AF [atrial fibrillation] was attributed to current use of diclofenac.”
We’re not sure what to make of this analysis. Naproxen might be better than ibuprofen when it comes to heart attacks but worse than ibuprofen when it comes to “major bleeding” or stroke. That’s not a great tradeoff. Moreover, more recent research throws the safety of naproxen into question. A randomized controlled trial including nearly 25,000 people found no better safety record for naproxen than for celecoxib (Celebrex) or ibuprofen (New England Journal of Medicine, Dec. 29, 2016). We discussed this study in depth with Dr. Steve Nissen, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic.
Here are some stories from readers to bring all this into focus. You can read more in the comment section below this article.
Rick was quite athletic and healthy until this happened:
“The whole range of NSAIDS can damage your kidneys and in doing so increase the odds of acidosis. I lost my left eyesight by taking indomethacin while being dehydrated after a 50 kilometer bike ride on a hot day. Apparently it caused the macula to pull away from the retina and in doing so pulled a hole in it. I was lucky the same thing happened to my right eye but fortunately did not damage the retina.”
Nana from Houston shared this:
“Had I known about the dangers of ibuprofen before this past summer, I may of not had the double STEMI’s [heart attacks] last year. And, no one told me to quit taking Ibuprofen for my aches and pains after I had the STEMI’s. I heard it on national news. I am also now in heart failure. I live with the arthritis pains, torn meniscus (cannot have surgery now) and periodic abscess tooth. Tylenol barely touches my pain.”
Sherry in Waxhaw, NC points out that it took the FDA a long time to discover that NSAIDs could cause heart problems:
“All I have to say is thank you and AMEN!
“Whenever I tell my doctors I don’t like all the side effects of a drug they want to prescribe, they say to me that if I read the side effects of an Advil, I wouldn’t take that either. I can show them this great article. Of course as usual they will say these are ‘rare’ occurrences.
“If it took the FDA 50 years to figure the NSAIDS out, hopefully they will figure out much sooner that the Fluoroquinolone drugs such as Cipro, Levaquin Avelox and Floxin are very toxic and harming more people than ever reported. It’s been about 30 years since some of them have been around and I have been sick for 21 years out of the 30!”
Here is what the FDA says about NSAIDs and the heart:
“Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech…the prescription NSAID labels will be revised to reflect the following information:
- 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.
- It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
- In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
- Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
- There is an increased risk of heart failure with NSAID use.
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.”
The FDA requires no such warnings on OTC NSAID packaging. The FDA assumes that people will follow the instructions on the label that say to take for only a short period of time. We suspect that many people ignore that recommendation.
People who cannot take NSAIDs may find our Guide to Alternatives for Arthritis of interest.
Revised: September 22, 2016
