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According to allegations raised in a product liability lawsuit filed against AstraZeneca and Procter & Gamble, side effects of Prilosec caused an Ohio man to suffer chronic kidney disease and acute interstitial nephritis (AIN) following years of using the popular heartburn drug.
The complaint (PDF) was filed by Bryan Gross, and his wife Ann, in the U.S. District Court for the Northern District of Ohio on June 8, indicating that the drug makers failed to provide adequate warnings about the potential kidney risks, as well as the importance of monitoring for signs of problems.
Gross indicates that he started using Prilosec in about 2009, and continued to use the heartburn drug through mid-2015, when he was told to stop by his nephrologist. As a result of the Prilosec use, Gross claims he developed acute interstitial nephritis (AIN), which involves inflammation of the kidneys, which ultimately led to chronic kidney disease (CKD).
Prilosec is a member of a popular class of acid reflux and heartburn medications known as proton pump inhibitors (PPIs), which also includes the blockbuster drugs Nexium, Prevacid, Protonix, Dexilant and others. The medications are used by millions of individuals worldwide and generate billions in sales each year for the drug manufacturers.
While the drugs are aggressively marketed as safe, and widely assumed to carry few serious side effects, several studies released in recent years have suggested that users actually face an increased risk of kidney problems from proton pump inhibitors, including acute kidney injury (AKI), acute interstitial nephritis (AIN), chronic kidney disease (CKD) and kidney failure.
“Prompt diagnosis and rapid withdrawal of the offending agent are key in order to preserve kidney function,” the lawsuit states. “While AIN can be treated completely, once it has progressed to CKD it is incurable and can only be managed, which, combined with the lack of numerous early-onset symptoms, highlights the need for screening of at-risk individuals.”
Gross maintains that the drug makers made this more difficult by failing to warn about the need for more regular medical monitoring than usual to ensure early discovery of these potentially serious side effects. Although AstraZeneca and Procter & Gamble allegedly knew or should have known about the risk, Gross indicates that false and misleading info was provided for consumers and the medical community.
In December 2014, the FDA required the drug makers to add information to the label for the first time about the risk of acute interstitial nephritis (AIN) from Prilosec, but many critics have suggested that the information was not prominent enough to raise awareness about the kidney risks associated with proton pump inhibitors.
In April 2015, a study published in the medical journal CMAJ Open found that Prilosec and other PPIs cause a 3 times higher risk of acute interstitial nephritis, but were also associated with a 2.5 times higher risk of acute kidney injury, which involves an abrupt loss of kidney function.
Last year, a study published in the medical journal JAMA Internal Medicine built on these findings, examining data on more than 10,000 participants over a period of more than 10 years, finding that the drugs were also associated with a higher incidence of chronic kidney disease.
In April 2016, researchers with the Department of Veterans Affairs found that users of 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.
The case joins dozens of other lawsuits over Prilosec side effects, as well as similar Nexium lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims brought on behalf of individuals nationwide in recent months.
As individuals continue to learn about the link between the GERD drugs and kidney problems suffered in recent years, it is widely expected that thousands of additional cases may be filed in the coming months and years.