Heartburn Drug Side Effects Study Finds No Link to C. Diff. Infections

Belgium researchers indicate that they could find no evidence of a link between the popular heartburn drugs like Nexium and C. diff infections, despite prior studies that have raised concerns about the widely used medications.

In a letter to the editor published in the March edition of the Journal of the American Geriatrics Society, researchers from the University Hospitals of Leuven, in Belgium, reported that they had conducted a study looking for an association between the use of a class of heartburn drugs known as proton pump inhibitors (PPIs) and nosocomial clostridium difficile, or c. diff infections (CDIs), that occurred among hospitalized elderly adults. However, they say they were unable to find any connection.

Proton pump inhibitors (PPI) are a widely used class of drugs, including blockbuster brand names like Nexium, Prilosec, Prevacid and others. The medications work by reducing the amount of stomach acid produced, helping prevent symptoms of heartburn and acid reflux. While the drugs are widely believed to be safe, and often used for years by consumers, a number of studies have raised concerns about the potential side effects of the heartburn drugs.

In November 2014, a report published in the medical journal Microbiome indicated that long-term use of Nexium and similar drugs could reduce the microbial diversity in the body, lowering its ability to fight off c. diff infections.

CDIs can lead to Clostridium difficile-associated diarrhea (CDAD), causing persistent diarrhea, water stool, abdominal pain and fever. It can eventually lead to more severe intestinal problems if not treated in a timely manner.

The FDA first warned of the link between drugs like Nexium and Prilosec and C. diff infections in a drug safety communication issued in February 2012, advising doctors to be aware of the potential connection when presented with patients taking heartburn medications whose diarrhea does not improve.

To evaluate the potential risk of C. diff infections from Nexium and other PPIs, researchers conducted a 30-month retrospective case-control study, involving 138 hospitalized individuals ages 75 and older. In addition to looking at whether they used one of the heartburn drugs, researchers also looked at whether they had been given antibiotics known to be a high risk for causing c. diff infections and other factors.

“PPI use was not found to be a risk factor for nosocomial CDI,” the researchers concluded. “Multiple studies have demonstrated that PPI use is a risk factor for CDI, but other studies did not find a clear association after adjustment for coexisting conditions.”

The findings come amid increasing concerns about a potential link between heartburn drugs and kidney problems, with a number of studies suggesting that use of the medications may increase the risk of acute kidney injury, chronic kidney disease and potentially kidney failure.

In late 2014, the FDA added further heartburn drug warnings about the risk of C. Diff associated diarrhea, and also indicated at that time that the medications have been linked to reports of acute interstitial nephritis, which involves kidney inflammation that may lead to more serious problems.

According to a study published by the medical journal CMAJ Open in April 2015, researchers indicated that users of Nexium, Prilosec or other heartburn drugs face an increased risk of kidney injury, which may lead to kidney failure.

This research was followed by a study published in the medical journal JAMA Internal Medicine in January 2016, which found that users also face an increased risk of chronic kidney disease from heartburn drugs.

A number of individuals throughout the United States who have suffered acute kidney injury, chronic kidney disease or renal failure are now pursuing potential Nexium lawsuits, Prilosec lawsuits and other claims against makers of proton pump inhibitors (PPI), alleging that the risk of kidney problems should have been included among warnings provided to consumers and the medical community.