While reports of injuries and death due to the side effects of proton pump inhibitors (PPIs) continue to rise, the FDA has granted approval for a generic “store brand” version of Nexium 24HR, an over-the-counter version of esomeprazole magnesium. The manufacturer, Dublin-based Perrigo Company PLC, plans to launch its new product toward the end of September.

FDA approval for the heartburn medication comes in the wake of Perrigo’s settlement of a patent lawsuit brought by the original manufacturer, AstraZeneca. The settlement was reached last week.

In the lawsuit, filed in 2015, AstraZeneca claimed that Perrigo infringed upon two of eight patents listed for Nexium 24HR. The settlement and FDA approval clears the way for Perrigo to begin production of its own generic version, which 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 the company press release.

Meanwhile, there are approximately 200 lawsuits currently pending against AstraZeneca that have been consolidated before a U.S. District Court in New Jersey. The complaints implicate both the prescription and OTC versions of Nexium. Plaintiffs allege that Nexium and other PPIs such as Prilosec caused chronic kidney disease and renal failure. In addition, these drugs have been linked to elevated risk of stroke, accelerated aging and dementia, colitis and pneumonia.

PPIs were intended for the short-term treatment of gastric reflux disorder. However, patients have been taking them for longer periods and using these medications for conditions that could be treated just as easily with lifestyle changes and diet modification. Because these medications have been marketed so aggressively and are so readily available, people who take them have not usually considered the side effects.

Research has appeared in at least three professional medical journals over the past two years documenting an association between PPIs and kidney damage. Yet, it was only recently that drug manufacturers updated their warning labels, noting the risk of a condition known as acute interstitial nephritis, a form of kidney inflammation. There have been no label warnings about other complications linked to the drug.

Plaintiffs allege that AstraZeneca and other drug makers were aware of these dangers and failed to inform consumers and the medical community. They also claim that had they known of these risks, they might have avoided the injuries they ended up suffering.

Meanwhile, Perrigo is moving forward with its plans to capture what the company says is part of a $300 million market. Hopefully, this company and those retailers planning to carry the product are learning from the current litigation, and will be providing full label disclosure of all risks and side effects associated with the medication.

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.