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After developing an acute kidney injury from Prilosec and Protonix, a Florida woman has filed a product liability lawsuit alleging the drug makers failed to adequately warn about the risks associated with use of the popular drugs for treatment of gastroesophageal reflux disease (GERD).
The complaint (PDF) was filed earlier this month by Cheryl Lear in the U.S. District Court for the Middle District of Florida, indicating that AstraZeneca, Wyeth Pharmaceuticals and Pfizer Inc. misrepresented the safety of Prilosec and Protonix to consumers and the medical community, indicating that the drugs had been tested and found to be safe for treatment of peptic disorders.
Lear indicates that she began taking prescription-strength Prilosec in March 2012, and continued to use the drug through September 2013. She was provided prescription-strength Protonix in February 2013, and used it through September 2013 as well. In March 2013, Lear indicates that she wsa diagnosed with an acute kidney injury, which the lawsuit alleges was caused by side effects of the GERD drugs.
Prilosec and Protonix are both members of a popular class of acid reflux and heartburn medications known as proton pump inhibitors (PPI), which also includes the blockbuster drugs Nexium, Prevacid, Dexilant and others. The medications are used by millions of individuals worldwide and generate billions in sales each year for the drug makers.
While the drugs are aggressively marketed as safe, and widely assumed to carry no serious side effects, several studies released in recent years have suggested that users actually 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.
Lear indicates that due to the false and misleading information provided by the drug makers, it took three years for her to discover the connection between use of Prilosec and Protonix and the kidny injury she suffered.
“The injuries and damages sustained by Plaintiff; CHERYL LEAR, were caused by Defendants’ Prilosec and Protonix and their unlawful conduct with respect to their design, manufacture, marketing and sale,” the lawsuit notes. “As a result of Defendants’ failure to warn and/or concealment of its knowledge that their Prilosec and Protonix caused kidney injuries, such as the one suffered by Plaintiff Cheryl Lear, Chery Lear did not discover, nor did she have reason to discovery, their wrongful conduct as alleged herein until July 2016.”
The FDA required the drug makers to update the warning label in December 2014, indicating for the first time that that there may be a risk of acute interstitial nephritis (AIN) from Prilosec, Protonix 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 variety of kidney risks associated with these medications.
In April 2015, a study published in the medical journal CMAJ Open found that Protonix, 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.
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 Protonix, 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, Protonix lawsuits, Nexium lawsuits, Prevacid lawsuits and other similar claims brought on behalf of individuals nationwide in recent months. As individuals continue to learn about the link between the GERD 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.