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AstraZeneca faces a product liability lawsuit that alleges side effects of Nexium caused chronic kidney disease for a New Jersey woman who used the popular heartburn medication over a period of several years.
The complaint (PDF) was filed by Bernita Garrison in the U.S. District Court for the District of New Jersey on August 18, alleging that the drug maker failed to warn users and the medical community about the risk of kidney damage associated with Nexium and other proton pump inhibitors.
Garrison indicates that she used Nexium from January 2011 through September 2014, and developed chronic kidney disease (CKD) in July 2014. The lawsuit indicates the drug maker knew or should have known about the link between Nexium and chronic kidney disease, yet placed their desire for profits before consumers safety by withholding information about risks associated with the popular medication.
Nexium is one of the most widely used brand name medications in the United States, taken by millions of Americans for treatment and prevention of acid reflux and heartburn. Since it is widely believed to be safe, it is often used for years, with little attempt to reduce or eliminate the need for the medication. However, a number of studies published in recent years have suggested that users may face serious kidney risks from Nexium.
The lawsuit filed by Garrison indicates that studies dating back to at least 1997 have linked Nexium and similar drugs, known as proton pump inhibitors (PPIs), to a number of kidney problems, including acute interstitial nephritis (AIN), kidney failure and chronic kidney disease. Concerns over CKD date back to at least 2007, years before Garrison began taking Nexium, the lawsuit indicates.
“Studies have shown the long term use of PPIs was independently associated with a 20% to 50% higher risk of CKD,” the lawsuit states. “In at least one study, the use of PPIs for any period of time was shown to increase the risk of CKD by 10%. As a whole, patients with renal disease are nearly twice as likely to have been exposed to PPIs compared to those without renal disease.”
In December 2014, the FDA required new warnings for the first time about the acute intersitital nephritis (AIN) risk from Nexium, Prilosec and other proton pump inhibitors. This condition involves inflammation of the kidneys, which can lead to more severe and chronic kidney damage. However, more recent independent studies have suggested that users also may face an increased risk of acute kidney injury, chronic kidney disease and end-stage renal failure.
According to the findings of a study published in the medical CMAJ Open in April 2015, individuals who started using PPI drugs had a 3 times higher risk of acute interstitial nephritis when compared to individuals who did not use the drugs, and a 2.5 times higher risk of experiencing acute kidney injury, which involves an abrupt loss of kidney function.
Earlier this 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 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.
The complaint filed by Garrison joins a growing number of Nexium lawsuits, Prilosec lawsuits, Prevacid lawsuits, Protonix lawsuits, Dexilant lawsuits and other claims involving allegations that users of proton pump inhibitors may have avoided severe kidney problems if the drug makers had adequately warned about the potential risks associated with the medications.
As heartburn drug injury lawyers continue to review and file cases, it is widely expected that thousands of cases could be filed in the coming months and years.