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The findings of new research suggests that the side effects of heartburn drugs like Nexium, Prilosec and Prevacid may be playing a significant role in the increasing incidence of recurring Clostridium difficile (C. diff) infections throughout the United States.
Researchers from the University of Pennsylvania Perelman School of Medicine published a study in the Annals of Internal Medicine on July 4, indicating that patients who used a class of heartburn drugs known as proton pump inhibitors face an increased risk of recurrent C. diff infections. The study also found an association between the infections recurring and the use of antibiotics, corticosteroids, and whether the patient was a resident in a nursing home.
The study was designed to look at the risk factors of multiple recurrent Clostridium difficile infection (mrCDI), and whether incidence of mrCDI are increasing in proportion to first-time C. diff infections. Researchers reviewed nationwide health data and found that the rate of multiple recurring C. diff infections had increased nearly 200% between 2001 and 2012, compared to just a 40% increase in regular C. diff infections.
Among those findings, researchers found that being female, having used antibiotics, proton pump inhibitors and corticosteroids all appeared to be contributing factors to the rapid increase of mrCDIs. The study also found links between chronic kidney disease and whether the patient was diagnosed in a nursing home.
The findings come after a number of other studies have linked the use of drugs like Nexium and Prilosec with an increased risk of C. diff infections.
Proton pump inhibitors (PPI) includes the most widely used drugs on the market in the United States, working 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 risks associated with heartburn drugs in recent years, including both a risk of infections, as well as kidney problems.
A study published in January indicated that there is nearly three times the risk of a C. diff infection or a Campylobacter infection among heartburn drug users.
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.
C. Diff infections 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.
PPI Kidney Failure Risks
The findings come as a growing number of Prilosec lawsuits, Prevacid lawsuits, Protonix lawsuits and other product liability claims continue to be filed against the makers of proton pump inhibitors, alleging that the drug makers have withheld important risk information from consumers and the medical community for years.
In late 2014, the FDA required the drug makers to add new 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. That was the first and only indication provided to consumers and doctors about the risk of kidney damage, and many critics argue that it was buried in the warnings and drug information.
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.
Those findings were supported by another study published in April 2016, in which researchers with the Department of Veterans Affairs found that users of Nexium, Prilosec or other PPIs may be 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease after five years of use.”
According to allegations raised in several hundred product liability lawsuits, if warnings about the kidney risks with Nexium, Prilosec and other PPI medications had been provided, many users may have avoided serious and potentially life-threatening injuries.
Given similar questions of fact and law raised in the complaints, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to consider whether to centralize the cases before one federal judge later this month, for consolidated discovery and pretrial proceedings.