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AstraZeneca knew or should have known about the link between side effects of Nexium and kidney problems, yet continued to aggressively market their popular heartburn drug and withheld important safety information from consumers and the medical community, according to allegations raised in a product liability filed by a many diagnosed with renal failure after using the medication for about three years.
The complaint (PDF) was filed by James McCoy in the U.S. District Court for the Eastern District of Louisiana on December 30, indicating that AstraZeneca failed to adequately warn about the risk of renal failure, chronic kidney disease and other kidney injuries associated with Nexium.
Nexium is one of the most widely used brand-name medications in the U.S., which is part of a popular class of heartburn drugs, known as proton pump inhibitors (PPI). Other members of this class include Prilosec, Prevacid, Protonix, Dexilant and others.
McCoy indicates that he was initially prescribed Nexium in July 2012, and continued to use the medication until April 2015, which allegedly caused him to develop renal failure. The lawsuit maintains that McCoy never would have used Nexium if he and his doctor had been appraised of the potential PPI side effects.
Since Nexium and other PPI drugs lack any kidney disease or renal failure warnings, they are widely believed to be safe by most consumers and doctors, and many individuals remain on the medications for years with little attempt to reduce use. However, a number of studies published in recent years have highlighted serious risks, including acute interstitial nephritis (AIN), acute kidney injury (AKI), chronic kidney disease (CKD) and end-stage renal failure.
“During the period in which Nexium has been sold in the United States, hundreds of reports of injury have been submitted to the FDA in association with ingestion of Nexium and other PPIs,” the lawsuit states. “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 Nexium by as early as 2004. These reports of numerous kidney injuries put Defedandants on notice as to the excessive risks of kidney injuries related to use of Nexium. However, Defendants took no action to inform Plaintiff or Plaintiff’s physicians of this known risk. Instead, Defendants cotninued to represent that Nexium did not pose any risks of kidney injury.”
In an independent study published by the medical journal CMAJ Open in April 2015, researchers found that users of PPI medications were 3 times more likely to suffer acute interstitial nephritis, and 2.5 times more likely to develop acute kidney injury, which involves an abrupt loss of kidney function.
This research was followed by a study published last year in the medical journal JAMA Internal Medicine, which also 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.
In April 2016, researchers with the Department of Veterans Affairs found that users of Nexium, Prilosec or other PPIs may be 96% more likely to develop renal failure and 28% more likely to develop chronic kidney disease after five years of use.
McCoy presents claims for negligence, fraud, misrepresentation, breach of express and implied warranty, infliction of emotional distress and strict product liability
The complaint joins dozens of other Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and Dexilant lawsuits brought by individuals nationwide in recent months, indicating that the drug makers withheld information from consumers and the medical community about the side effects of PPI medications.
As PPI drug injury lawyers continue to review and file cases, it is expected that thousands of cases with similar claims could be filed in the coming months.