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.

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.