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A Pennsylvania man indicates that he will require life-long medical treatment and monitoring, after suffering kidney failure side effects from Prilosec OTC and Prevacid 24HR, two widely used acid reflux drugs that have been linked to a growing number of reports involving serious kidney injuries.
In a product liability lawsuit (PDF) filed last week in the U.S. District Court for the District of New Jersey, Paul Snyder indicates that the drug makers Novartis, GlaxoSmithKline, Proctor & Gamble, AstraZeneca, and Takeda Pharmaceuticals failed to adequately warn consumers and the medical community about the potential health risks associated with their medications.
Snyder indicates that he developed acute renal failure and end stage renal disease after long-term use of Prevacid 24HR and Prilosec OTC, which are both part of the same class of heartburn medications, known as proton pump inhibitors (PPI).
Together with Nexium, Protonix and other popular brands, the medications are some of the most widely recognized drugs on the market in the United States, used by more than 15 million Americans. However, concerns have emerged in recent years about serious kidney side effects and whether the medications may be widely overused.
“During the period in which Prevacid 24HR and Prilosec OTC have been sold in the United States, hundreds of reports of injury have been submitted to the FDA in association with ingestion of Prevacid 24HR, Prilosec OTC and other PPIs,” according to the complaint filed on September 26. “Defendants have had notice of serious adverse health outcomes through case reports, clinical studies and post market surveillance. Specifically, Defendants had received numerous case reports of kidney injuries in patients that had ingested Prilosec OTC by as early as 2003, and Prevacid 24HR by as early as 2009. These reports of numerous kidney injuries put Defendants on notice as to the extensive risks of kidney injuries… However, Defendants took no action to inform Plaintiff or Plaintiff’s physicians of this known risk. Instead, Defendants continued to represent that Prevacid 24HR and Prilosec OTC did not pose any risks of kidney injuries.”
The case joins a growing number of other Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and Dexilant lawsuits brought by individuals nationwide in recent months, each involving similar allegations that the drug makers withheld information about the risks associated with long-term use of the medications.
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 may 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.
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 Prevacid and 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, Prevacid 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, Prevacid 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.
Given similar questions of fact and law raised in the litigation, the Prilosec and Prevacid lawsuit filed by Snyder will be consolidated with cases filed against other drug makers, which are centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey as part of a federal MDL, or multidistrict litigation.
As individuals continue to learn about the link between the heartburn 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.