As Proton Pump Inhibitor Lawsuits Mount, Generic Drug Maker Plans to Launch Store-Brand Version of Nexium 24HR

Published on August 29, 2017 by Sandy Liebhard

Perrigo Company PLC has reached final approval from the U.S. Food & Drug Administration (FDA) to market a store-brand equivalent of Nexium 24HR. The company plans to launch the product by late September.

The generic drug maker’s announcement comes as plaintiffs throughout the United States continue to file proton pump inhibitor lawsuits for kidney failure and other renal complications allegedly associated with the long-term use of Nexium and similar heartburn drugs.

Perrigo, AstraZeneca Settle Patent Lawsuit

In a press release dated August 21^st, Perrigo noted that it had recently settled a patent lawsuit with AstraZeneca, allowing it to move forward with a store-brand version of Nexium 24HR.

Nexium 24HR is the over-the-counter version Nexium, and is indicated to treat frequent heartburn (occurs 2 or more days a week).  Perrigo’s press release said the company’s soon-to-be-launched esomeprazole magnesium capsules will be “packaged and marketed as store brand or retailer ‘own label’ brand and will provide consumers with a high-quality, value alternative to Nexium^® 24HR capsules.”

According to Perrigo, approximate annual retail sales for Nexium 24HR exceeded $300 million over the past 12 months.

Proton Pump Inhibitor Kidney Litigation

Court records indicate that nearly 200 proton pump inhibitors lawsuits are pending in a multidistrict litigation currently underway in the U.S. District Court, District of New Jersey, all of which were filed on behalf of individuals who suffered kidney failure, chronic kidney disease, and other renal complications allegedly related to their treatment with prescription and over-the-counter versions of Nexium, Prilosec, and PrevAcid, among others.

While proton pump inhibitors are intended for the short-term treatment of GERD and other gastric disorders related to the overproduction of stomach acid, research has shown that these drugs are often taken for inappropriate indications and for far longer periods of time than what is currently recommended. And because proton pump inhibitors have become so commonplace, most people give their potential side effects little – if any – thought.

Nexium lawsuits and other claims pending in the federal litigation point to a growing body of research that suggests long-term treatment with proton pump inhibitors could be harmful to the kidneys, including:

•  A study reported by CMAJ Open in April 2015 linked proton pump inhibitors to a 3-fold increase in the risk for acute interstitial nephritis, as well as a 2.5 times higher risk of acute kidney injury.
• Research published in JAMA Internal Medicine in January 2016 suggested that proton pump inhibitors might increase the risk of chronic kidney disease by as much as 50%.
• A paper appearing in the Journal of the American Society of Nephrology in April 2016 reported that long-term users of proton pump inhibitors may be 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease compared to patients using H2-blockers.

The complaints note that the labels for prescription proton pump inhibitors were only recently updated with mention of acute interstitial nephritis as a possible side effect. However, the labels have not been modified to list any other possible kidney complications.

Plaintiffs allege that the manufacturers of Nexium and other proton pump inhibitors have long been aware that their products could damage the kidneys, but failed to provide the public with appropriate safety warnings. They further assert that that their kidney problems could have been avoided if they had been provided with adequate notice of these risks.