Aleve, Similar Painkillers May Increase Risk of Gastrointestinal Bleeding In High-Risk Patients: Study

Researchers indicate that Aleve, Midol and other naproxen-based medications may be associated with a higher risk of gastrointestinal bleeding when compared to the pain killer Celebrex, especially among high-risk patients. 

In a study published last month in the medical journal The Lancet, Chinese researchers compared the gastrointestinal safety of Celebrex with naproxen-based painkillers, among patients with cardiothrombotic diseases and arthritis who already had experienced gastrointestinal bleeding. The findings suggest that the odds of suffering another bleeding event increased when those patients took Aleve and similar drugs.

The research involved a randomized, double-blind clinical trial with 514 patients, half of whom were given Celebrex (celecoxib) and half given naproxen-based medications to treat arthritis pain and cardiothrombotic diseases. All were also given 80mg of aspirin per day.

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Naproxen is available over-the-counter as Aleve, Midol and in generic form and belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

According to the findings, 14 patients given Celebrex suffered recurrent upper gastrointestinal bleeding, including nine gastric ulcers and five duodenal ulcers. However, the group given naproxen suffered more than twice that many incidents, with 31 patients suffering upper gastrointestinal bleeding events, including 25 gastric ulcers, three duodenal ulcers, one gastric ulcer with duodenal ulcer and two bleeding erosions.

“In patients at high risk of both cardiovascular and gastrointestinal events who require concomitant aspirin and NSAID, celecoxib plus proton-pump inhibitor is the preferred treatment to reduce the risk of recurrent upper gastrointestinal bleeding,” the researchers determined. “Naproxen should be avoided despite its perceived cardiovascular safety.”

NSAID Heart Concerns

The findings come amid continuing concerns over the cardiovascular safety of Celebrex, Aleve and other painkillers. In November 2017, a study found that the Celebrex heart risks were about the same as those of similar drugs.

Concerns regarding Celebrex heart problems first emerged more than 10 years ago, prompting the FDA to issue a black box warning for the drug, which is the strongest warning the agency can require manufacturers to place on a medication packaging, placed in a prominent box to call attention the the possible risks and side effects.

In 2014, an FDA advisory panel called for Aleve to carry strong warnings concerning heart risks to patients as well. A study also published that year indicated people taking Advil and Motrin had an 84% increased risk of developing abnormal heart rhythm, or atrial fibrillation.

Another arthritis drug was pulled from the market after concerns of serious side effects were raised. In 2004, reports of Vioxx linked to heart attacks and other heart deaths were reported. The drug was originally approved in 1999 as a painkiller in the same class as Tylenol and Advil.

The findings of the latest study, if confirmed, would indicate that while the heart risks may be similar, Aleve and other naproxen drugs carry a higher bleeding risk.

In 2011, Merck settled a lawsuit with the federal government by paying $950 million concerning off-label marketing and prescribing that led to widespread health problems.

The NSAID market is a lucrative business. In the U.S. Americans spent $1 trillion in 2015 for Celebrex, Aleve, Motrin and Advil. This was a drop from $2.8 trillion in 2014.

15 Comments

  • PeterDecember 15, 2021 at 7:39 pm

    Same here. I took alieve pm for years but recently I had a car accident and the Dr prescribed naproxen 500mg. Shortly after I developed severe bleeding. I went to the ER on 10/23/2021 and almost passed away. I received 9 units of blood in 8 days in ICU. I had a colon oscopy, endoscopy. CT scans and a radioactive procedure before it was found and a anginagram was completed to stop the bleeding. [Show More]Same here. I took alieve pm for years but recently I had a car accident and the Dr prescribed naproxen 500mg. Shortly after I developed severe bleeding. I went to the ER on 10/23/2021 and almost passed away. I received 9 units of blood in 8 days in ICU. I had a colon oscopy, endoscopy. CT scans and a radioactive procedure before it was found and a anginagram was completed to stop the bleeding. It was torture for two weeks. Never again will I take alieve or naproxen of any kind. The hopspital charges 295000.00 not including doctors bills and I was thrown out of the hospital in the early morning by ambulance to another hospital that accepted my insurance. Terrible ordeal. 8500 deducted.

  • JamesNovember 12, 2021 at 4:45 pm

    My wife suffers from small bowl bleeding. She took aleve and and aleve pm for years now causing pain and bleeding. The way they found the bleeding was by camera pill. She is now waiting for procedure to repair same.

  • JamesJune 28, 2021 at 7:46 am

    I had a gi bleed caused by nsaids and will not touch them ever again

  • MaurineMay 25, 2021 at 4:27 am

    I have lost the majority of my kidney function as a result of taking aleve or Naprosyn. Are there any class action lawsuits for these damages?

  • JohnApril 16, 2021 at 9:00 am

    I lost my kidneys in 2018 due to high doses of naproxen the Dr prescribed to me after back surgery for pain. I know am waiting for a kidney transplant and due dialysis every night while I sleep, I could use some help since I was a corrections officer making 50k a year to now 15k on disability.

  • MichaelDecember 6, 2020 at 10:43 am

    I've been taking naproxen for a little over a few year since me and lady have gotten to together and she said it was good pain relief well I guess it wasnt so good after all cause now I have bleeding ulcers and I just got out of the hospital for low hemoglobin I could have died the doc said and I'm still not out of the water yet

  • StephanySeptember 3, 2020 at 5:27 pm

    I just got out of the hospital from an intestinal bleeding attack. During a scan of my abdomen, it was found that my right kidney has shut down. I spoke with a Nephrologist this morning concerning my kidney. He stated that it died from lack of circulation he believes was caused from the use of Ibuprofen and Naproxen for pain for many years now. Does anyone know of a place I can research to see if [Show More]I just got out of the hospital from an intestinal bleeding attack. During a scan of my abdomen, it was found that my right kidney has shut down. I spoke with a Nephrologist this morning concerning my kidney. He stated that it died from lack of circulation he believes was caused from the use of Ibuprofen and Naproxen for pain for many years now. Does anyone know of a place I can research to see if I have a case for compensation? Thank you for any information anyone can provide.

  • DianeJuly 13, 2020 at 6:18 pm

    In my previous email I forgot to mention my husband was 51 when he passed. Excellent health and very active in sports and recreational walking and daily activities that this unfortunate incident was a shock to all that knew him.

  • DianeJuly 13, 2020 at 6:10 pm

    My husband took Aleve for pain for year’s thinking it was safe. He passed in 2015 from stomach cancer; enduring multiple surgeries (holes in both intestines) and multiple tumors. No advance issues other than 3 months before July diagnosis he was experiencing stomach discomfort that doctors mistakenly diagnosed as an infection.

  • StevenJune 2, 2020 at 5:06 am

    I was hospitalized over an ulcer on my intestines and it ruptured on the 4th of March 2020 I now have a 10 in scar on my stomach. When I woke up in the hospital me of the first questions I was asked by the Dr who performed my surgery was do you take naproxen based meds and it made since at the moment but I’m a 47 year old man with a huge scar. What do I need to do or am I to late to get in on this[Show More]I was hospitalized over an ulcer on my intestines and it ruptured on the 4th of March 2020 I now have a 10 in scar on my stomach. When I woke up in the hospital me of the first questions I was asked by the Dr who performed my surgery was do you take naproxen based meds and it made since at the moment but I’m a 47 year old man with a huge scar. What do I need to do or am I to late to get in on this suit?

  • MauraFebruary 12, 2020 at 3:37 am

    I have been taking aleve for pain instead of getting hooked on narcotic and now I'm bleeding internally do I have a case...

  • MargaretJanuary 23, 2020 at 4:02 pm

    I been taking Aleve for years and now I have lesions in my GI. Who can I contact concerning the lawsuit?

  • DorothyDecember 27, 2019 at 5:26 pm

    From taking Motrin 2400mg to 2800mg per day since approximately 1970s, I have had many episodes of severe ulcers with projectile vomiting enough to fill a hospital bath basin at times. Also had horrible episodes of arrythemias until forced to have pacemaker due to complications of 3rd degree AV block and current end stage CHF. My heart was perfect before this.

  • MontelOctober 22, 2019 at 4:38 am

    My kidneys shut down from taking Aleve can I get some help.

  • LouiseSeptember 30, 2019 at 1:49 pm

    On June 7,2019 I had life threatening surgery on my stomach. I had a 1 cm hole in my stomach due to ALEVE. I would like to speak to someone or if you can forward your e-mail I could send you the letter sent to Bayer Pharmaceuticals and pics of my surgery. I could have died..

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