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Amid increasing concerns about the risk of kidney problems linked to popular heartburn medications, a lawsuit filed last week against alleges that side effects of Prilosec caused a Kansas woman to develop end-stage renal disease, or kidney failure.
The complaint (PDF) was filed by Jackie Koon in the U.S. District Court for the District of Kansas on August 31, claiming that the drug maker knew or should have known about the kidney risks associated with their blockbuster medication, yet failed to adequately warn consumers or the medical community.
Koon indicates that she was first prescribed Prilosec in 2010, for the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease, and gastropathy caused by nonsteroidal anti-inflammatory drugs (NSAIDs). She continued using the medication until at least 2013, and indicates that there is a direct connection between Prilosec and kidney failure she has since developed, which has left her with a need for lifelong medical treatment and monitoring.
According to the lawsuit, AstraZeneca has received hundreds of adverse event reports involving kidney problems from Prilosec, yet failed to provide adequate warnings or information on the drug label.
“Specifically, Defendants had received numerous case reports of kidney injuries in patients that had ingested Prilosec by as early as 1989,” the lawsuit states. “These reports of numerous kidney injuries put Defendants on notice as to the excessive risks of kidney injuries related to the use of Prilosec. However, Defendants took no action to inform Plaintiff or Plaintiff’s physicians of this known risk. Instead, Defendants continued to represent that Prilosec did not pose any risk of kidney injuries.”
Prilosec belongs to a class of heartburn medications known as proton pump inhibitors (PPIs), which also includes Nexium, Prevacid, Protonix, Dexilant and others. It is estimated that more than 15 million Americans used prescription-strength PPIs in 2013 alone, earning the manufacturers of these drugs a combined $10 billion.
In December 2014, the FDA required new warnings for the first time about the acute intersitital nephritis (AIN) risk from Prilosec, Nexium 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. Both conditions can progress to end-stage renal disease, or kidney failure.
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 Prilosec, Nexium 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 Koon joins a growing number of Prilosec lawsuits, Nexium 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.