One of the world’s most popular medications has been linked to kidney failure. AstraZeneca’s Nexium, the “purple pill” prescribed to millions of gastrointestinal disease sufferers each year, could increase the risk of developing chronic kidney disease by up to 50% – leaving thousands in danger of a premature death.
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Patients aren’t taking this news lying down. Multiple former patients have already filed suit, claiming Nexium’s Swiss manufacturer failed to warn them of the drug’s potential risks.
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Lawsuits Filed Over Nexium, Proton Pump Inhibitors
Nexium is the most popular drug in a class of chemicals known as proton pump inhibitors, which inhibit the stomach’s ability to secrete gastric acid.
In short-term, low-dose courses of treatment, the drugs can work wonders for patients with gastrointestinal ulcers or acid reflux disease. But they can also be hard to stop taking. Many patients experience a debilitating spike in symptoms after discontinuing treatment. That’s a major problem since the long list of side effects associated to PPIs are aggravated by long-term usage.
Out of the numerous side effects to which Nexium has been linked, the most common include:
- nausea and vomiting
- stomach pain
- gas and constipation
- drowsiness and fatigue
- dry mouth
- dizziness and anxiety
Thankfully, these side effects are fairly minor, and should clear up after a patient stops taking the medication. But now that Nexium is available in an over-the-counter formulation, sold as Nexium 24HR, it’s not at all clear that patients are ever discontinuing the treatment. Perhaps more importantly, these symptoms are all listed clearly on the drug’s warning label, allowing patients to make their own informed decisions about what they feel comfortable taking. That’s a courtesy many patients believe AstraZeneca never extended to cover Nexium’s more serious potential risks.
Those serious risks aren’t limited to kidney conditions, either. Chronic kidney disease and kidney failure are only the most recent dangers to be associated with Nexium and other medications of its like.
AstraZeneca is already facing dozens of Nexium lawsuits filed over an increased risk of bone fractures. In a number of medical studies, researchers have found that Nexium can boost the danger of breaking hip and spine bones by between 45% and 60% when used for more than one year or at high dosages.
Filing both individual personal injury lawsuits and class actions, patients say they were never notified of the danger, claiming AstraZeneca has known for years that Nexium could weaken bones. And while the FDA added a new warning about bone density to Nexium in 2010, patients injured before that date say the drug’s labeling change came too late. Nexium has been on the market since 2001.
Some Plaintiffs have even called the federal agency’s response into question. Nexium’s warning label was only updated to include bone fracture risks after a public advocacy group, Washington, D.C.’s Public Citizen, sued the FDA over the issue.
Overprescribed Heartburn Meds May Pose High Risks
Proton pump inhibitors are undoubtedly overprescribed. Speaking to CNN in 2010, director of the San Francisco Department of Public Health Mitchell Katz MD estimated that anywhere between 60% to 70% of patients taking the drug “probably don’t need them.”
Where indigestion and heartburn are concerned, lifestyle changes should be attempted before resorting to drugs, Katz says, but few doctors are heeding his advice. That’s especially troubling now that the risk-benefit profile of proton pump inhibitors is receiving renewed scrutiny.
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[PPIs] first came out, people felt they had no side effects,” Katz told reporters. “Now you’re talking about increased fractures, increased C. difficile infection, increased rates of pneumonia. The balance has changed.” As we’ve seen, more recent research has found an association between proton pump inhibitors and serious kidney damage, shifting that balance, between benefit and risk, even further to the side of danger.
Kidney Failure: Is AstraZeneca Bracing For Wave Of Litigation?
With a new, and potentially deadly, side effect now identified, many legal experts believe it’s only a matter of time before hundreds of Nexium patients file suit against AstraZeneca.
The prospect of mass litigation probably has AstraZeneca worried. The company has already been forced to settle multiple major Nexium lawsuits over the drug – three in the same year. Here’s a run-down of Nexium’s recent legal troubles.
- After ten years of litigation, AstraZeneca was found liable in February 2015 for promoting Nexium as a more effective alternative to Prilosec, a proton pump inhibitor made by Procter & Gamble. Filed as a class action, the case came to a close with a $20 million settlement.
- That same month, AstraZeneca agreed to settle a case filed by the US Justice Department over allegations that the company had orchestrated an illegal kickback scheme to boost sales of Nexium. The company consented to a settlement of almost $8 million.
- In June 2015, generic drug manufacturer Teva Pharmaceuticals found itself on the wrong end of a Nexium conspiracy lawsuit. In the suit, plaintiffs claimed that AstraZeneca had paid Teva to intentionally withhold a Nexium generic from the market, artificially inflating the brand name drug’s sales price. The settlement came to $24 million.
None of these lawsuits, however, had anything to do with Nexium’s potential side effects. For now, allegations that AstraZeneca failed to warn the public of its blockbuster drug’s risks are still waiting for their day in court.