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Amid increasing concerns about the potential side effects of Nexium, Prilosec, Prevacid and other popular heart burn drugs, known as proton pump inhibitors (PPI), new research suggests that users may face an increased risk of death when taking the medications at prescription strength.
In a study published online this week by the medical journal BMJ Open, researchers from the VA St. Louis Health Care System found that prolonged use of proton pump inhibitors was associated with a 25% increased risk of death when compared to individuals who took other types of heartburn drugs, known as H2 receptor antagonists.
Proton pump inhibitors include many of the most widely used drugs on the market in the United States, such as Nexium, Prilosec, Prevacid and others. The medications work by reducing the amount of stomach acid produced, helping prevent symptoms of heartburn and acid reflux.
For years, the drugs have been widely believed to be safe, and are often used for years without little attempt to reduce need for the drugs, since they have been linked to few serious side effects. However, a number of independent studies published in recent years have raised concerns about the risk of serious and potentially life-threatening kidney damage, as well as other health problems.
H2 receptor antagonists are an older class of heartburn drugs, which include medications like Pepcid AC, Zantac and Tagamet. These drugs have not been linked to the same risk of kidney injuries.
In this latest study, researchers compared Department of Veterans Affairs data on millions to about 350,000 new users of PPIs or H2 receptor antagonists, also known as H2 blockers, with a median follow-up of 5.71 years. They compared the risks of death by comparing those who used one type of heartburn drug versus the other type, as well as comparing mortality rates of those who used either PPIs or H2 blockers to those using no heartburn medications.
According to the findings, users of drugs like Nexium and Prilosec had a 25% increased risk of death compared to those who used drugs like Zantac and Tagamet. Additionally, the results were similar when researchers looked at PPI users compared to those who used no heartburn drugs at all, and the risk of death increased if the person had no gastrointestinal problems.
“The results suggest excess risk of death among PPI users; risk is also increased among those without gastrointestinal conditions and with prolonged duration of use,” the researchers concluded. “Limiting PPI use and duration to instances where it is medically indicated may be warranted.”
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.