Prilosec Wrongful Death Lawsuit Filed Over Failure to Warn About Kidney Risks

AstraZeneca failed to adequately warn users and the medical community about the potential kidney risks with Prilosec, according to allegations raised in a recent wrongful death lawsuit filed by the family of a man who died from kidney failure following use of the popular heartburn drug.

The complaint (PDF) was filed by Alejandro Rodriguez in the U.S. District Court for the District of Kansas on October 28, indicating that his father, Frank Rodriguez, suffered serious injury to his kidney and subsequently died in 2014, after using Prilosec and other proton pump inhibitors (PPI) for 12 years.

Prilosec (omeprazole) is part of a popular class of acid reflux and heartburn medications, which also includes Nexium and Prevacid. Known as proton pump inhibitors, the drugs are used by millions of individuals worldwide and generate billions in sales each year.

While the drugs are aggressively marketed, and widely assumed to be safe, several studies released in recent years have suggested that users may face an increased risk of kidney problems proton pump inhibitors, including acute interstitial nephritis (AIN), chronic kidney disease (CKD) and kidney failure.

“Defendants knew or should have known that between 1992 and 2004 over 23 cases of biopsy-proven AIN secondary to omeprazole (Prilosec) had been reported,” the lawsuit states. “In 2004, Defendants knew or should have known of 8 biopsy-proven case reports from Norwich University Hospital in the United Kingdom.”

The FDA required the drug makers to update the warnings in December 2014, indicating for the first time that that there may be a risk of acute interstitial nephritis (AIN) risk from Prilosec, Nexium and other proton pump inhibitors. This condition involves inflammation of the kidneys, but plaintiffs maintain that the warnings do not go far enough to raise awareness about the serious risks associated with these medications.

In April 2015, a study published in the medical journal CMAJ Open found that Nexium, 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.

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 case joins dozens of similar Prilosec lawsuits, Nexium lawsuits, Prevacid lawsuits and other similar claims brought on behalf of individuals nationwide in recent months, and it is widely expected that thousands of additional cases may be filed in the coming months and years, as more individuals and families learn that kidney problems experienced in recent years may have been caused by the use of a proton pump inhibitor.