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Popular heartburn drugs like Nexium, Prilosec, and Prevacid may cause an increase in plaque in the aorta for certain patients, which could result in an increased risk of heart attacks, strokes and death, according to the findings of new research.
In a study published this month in the medical journal PLOS One, Japanese researchers indicate that a class of heartburn medications known as proton pump inhibitors (PPIs) are linked to hypomagnesemia and vascular calcification among patients undergoing dialysis.
The study involved 200 patients undergoing maintenance hemodialysis (HD) from 2016 and 2017. The patients underwent regular blood tests and computed tomography (CT) scans and their abdominal aortic calcification levels were measured. Researchers also looked at which patients were given drugs like Nexium and which were not.
According to the findings, levels of serum magnesium were significantly lower in the PPI group, and median abdominal aortic calcification was significantly higher. The researchers calculate that the use of Nexium, Prilosec and similar drugs are more than twice as likely to increase the risk of higher vascular calcification and low serum levels.
“The present study suggested that PPIs may play a role in the progression of aortic calcification in patients on maintenance HD,” the researchers concluded. “Further studies should be needed to clarify the impact of PPIs on vascular calcification progression among these patients.”
The findings appear to back up a warning issued by the FDA in 2011, when the agency released a drug safety communication indicating that long-term use of proton pump inhibitors may cause low serum magnesium levels.
Hypomagnesemia can cause serious side effects, including muscle spasms, irregular heartbeats, and convulsions. According to the FDA, the condition cannot be simply treated through the use of magnesium supplements and in most cases the patient had to be taken off PPIs for their magnesium levels to return to normal.
The FDA found more than 50 cases of hypomagnesemia that were likely caused by heartburn drug side effects in medical literature and through adverse events reported to the agency. While in some cases it appeared in adults who had only been taking drugs like Prilosec and Nexium for just three months, in most cases it appeared after about a year of use.
Patients taking PPIs should seek immediate medical attention if they experience abnormal heart rates or rhythms, palpitations, muscle spasms, tremors or convulsions, according to the warnings. Children may demonstrate signs of hypomagnesemia as fatigue, upset stomach, dizziness or lightheadedness.
PPI Kidney Failure Litigation
This latest study comes as more than 4,500 Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims are being purused against the makers of PPI drugs by former users diagnosed with acute kidney injury, chronic kidney disease and end-stage renal failure, which may result in the need for dialysis treatment.
The proton pump inhibitor litigation has rapidly emerged following the publication of several studies in recent years, which suggest that users may face certain kidney risks that are not disclosed on the warning labels for the popular heartburn drugs.
The FDA required new warnings about potential kidney risks for the first time in December 2014, indicating that use of the drugs may increase the risk of a form of kidney damage known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems. However, plaintiffs maintain that this warning remains inadequate and vague, failing to mention that the drugs may cause an acute kidney injury, chronic kidney disease or kidney failure.
In January 2016, an indepedent study published in the medical journal JAMA Internal Medicine found an increased risk of chronic kidney disease with the heartburn medications, indicating that users of Nexium, Prilosec and other PPI may be 50% more likely when compared to non-users.
These findings were followed 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.
In addition to lawsuits over kidney problems, a number of individuals are now investigating potential stomach cancer lawsuits over Nexium, Prilosec and other PPI drugs following recent studies that suggest users may be more likely to develop gastric cancer.