Pharmaceutical giant AstraZeneca may be headed toward serious legal trouble. In several breaking lawsuits, patients who took Nexium say the company’s massively popular heartburn drug can cause debilitating kidney damage. Citing more than a decade of medical research, the patients accuse AstraZeneca of concealing vital safety information from the public and health community.
Legal experts believe that these patients have kickstarted a litigation that will only grow in the coming months. Thousands of people who suffered kidney injuries after taking Nexium may also be eligible to pursue compensation.
Kidney Failure, Renal Diseases Spur Nexium Lawsuits
On July 5, 2016, a Tennessee man filed what is believed to be the second Nexium lawsuit over kidney disease.
Charles Bowers, the suit’s Plaintiff, says he took Nexium “on numerous occasions” from July 2003 to May 2008, using the drug to treat acid reflux and gastrointestinal ulcers. He was diagnosed with an acute form of kidney inflammation, according to court documents, which was explicitly identified as a “drug-induced” disorder by his physician. After resuming his Nexium treatments, Bowers suffered an even greater shock, receiving a diagnosis of chronic kidney inflammation just one year after his first diagnosis.
Bowers says he now requires dialysis treatments three times a week “and is required to have a kidney transplant.” In his own case, the first to be filed over Nexium’s link to kidney injuries, an Illinois man says he was forced to undergo a kidney transplant in 2006 after being prescribed Nexium in the same year.
AstraZeneca “Concealed” Risk Data, Plaintiffs Claim
None of these devastating alleged injuries were unavoidable, Plaintiffs say. As early as 2004, they write, AstraZeneca had received “numerous” reports of kidney injuries. But instead of warning the public, or notifying the FDA, the company chose to portray Nexium as a safe drug, one without any risk of kidney damage, according to the complaint.
Evidence of a risk to kidney health would only mount over the next decade, as researchers discovered troubling links between proton pump inhibitors and two debilitating kidney disorders: acute interstitial nephritis and acute kidney injury. With a sudden onset and relatively non-specific symptoms, these “acute” forms of kidney malfunction can rapidly progress to chronic, even deadly, renal conditions.
From Acute To Chronic
Indeed, further research has identified a potential link to chronic kidney disease (CKD), a condition marked by gradual deterioration of kidney function.
In a 2016 paper published in the Journal of the American Medical Association, researchers at Johns Hopkins found that, among 10,482 patients, those who took proton pump inhibitors were 45% more likely to develop chronic kidney disease. In a separate cohort of patients, numbering more than 248,000 people, a similarly elevated risk was observed. Crucially, the dangers appeared to be associated with dosage. Patients who took a PPI once daily were around 15% more likely to suffer CKD. Twice-daily dosing boosted the risk estimate to 45%, suggesting a direct link between the chemical and kidney damage.
But in his own case, Bowers stresses one study in particular. In this 2015 paper, researchers found that elderly patients were 250% more likely to suffer an acute kidney injury after taking PPIs for just 120 days.
It’s not surprising that Bowers highlights this particular study. He claims to have been diagnosed with acute interstitial nephritis in 2008, after nearly 5 years of taking Nexium. One year later, after another prescribed course of Nexium treatment, Bowers was shocked by an even more serious diagnosis: severe chronic active interstitial nephritis. According to court documents, the condition has left him tethered to a dialysis machine, which he uses three times a week. Bowers is currently waiting for a kidney transplant, his complaint reports.
A Failure To “Adequately Warn”
Bowers emphasizes the fact that doctors have a wide variety of options in treating these gastric disorders. The choice isn’t limited to Nexium, or any other proton pump inhibitor for that matter. Bowers himself was given Nexium to treat gastroesophageal reflux disease (GERD) and duodenal ulcer disease.
The alternative? The Plaintiff points to a separate class of drugs, H2 antagonists, which he says are just as effective for these indications as Nexium. In reality, Bowers claims that he was prevented from making an informed choice about his treatment plan because AstraZeneca has never included a warning about chronic kidney disease. In his own words:
A warning about the risk of acute interstitial nephritis was added to the labeling of every proton pump inhibitor, including Nexium, in 2014. Of course, that was nearly six years after Bowers was diagnosed with the condition.
Bowers’ lawsuit, filed in the US District Court for the Western District of Tennessee, is logged under the case number 2:16-cv-02549-SHL-dkv.
Is Nexium A PPI?
Yes. Proton pump inhibitors, or PPIs, are a class of chemicals that block the production of gastric acids in the stomach. Nexium’s active ingredient, esomeprazole, is a purified version of omeprazole, the active ingredient in Procter & Gamble’s Prilosec, and thus considered a “second generation” PPI.
Nexium is the most widely-prescribed drug in this class and the third best-selling drug in the world. In 2008, AstraZeneca pulled in more than $5.2 billion from sales of Nexium alone.
Where safety is concerned, however, there seems to be little difference between one proton pump inhibitor and another. It’s crucial to note that every proton pump inhibitor drug has been linked to an increased risk of bone fracture, chronic kidney disease, and kidney failure.
Proton pump inhibitors are used to treat a wide range of medical conditions, from common indigestion and acid reflux disease to esophageal ulcers. But they haven’t been approved for all of these indications by the US Food & Drug Administration. Nexium itself is only approved for four discrete uses:
- to treat gastroesophageal reflux disease, often referred to simply as “acid reflux disease”
- to reduce the risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen
- to eradicate the bacterium Helicobacter pylori, which has been linked to the development of stomach ulcers and cancer. In this context, Nexium should be prescribed as one part of a “Triple Therapy,” along with the antibiotics amoxicillin and clarithromycin.
- to treat “pathological hypersecretory conditions,” like Zollinger-Ellison syndrome, in which a pancreatic tumor leads to the overproduction of gastric acid.
That fourth approval, for “pathological hypersecretory conditions,” is important. That’s the only indication for which Nexium has been approved as a long-term treatment. In every other case, researchers insist that Nexium should only be taken in short-term courses of treatment. For treating GERD, “short-term” means 4 to 8 weeks.
Researchers Troubled Over Long-Term Side Effects
In most cases, we don’t even have safety data from controlled studies on using Nexium for longer than 6 months. But in the real world, doctors aren’t sticking to short courses of treatment. That’s a real problem since long-term proton pump inhibitor has been poorly studied. Physicians haven’t really limited their prescription of proton pump inhibitors to approved indications, either.
Since their introduction to the US market in 1988, numerous studies have shown that PPI drugs are chronically over-prescribed, treated more like candy than potentially dangerous medications. After the first generic PPI was approved in 2002, things really ramped up. In the UK, prescriptions for proton pump inhibitors had doubled by 2007, according to researchers at King’s College Hospital. But there’s no evidence that diagnoses for acid reflux or H. pylori infections doubled during the same time period.
Similar problems have been observed in the US. In a review of 213 patients from Michigan, around 90% had been prescribed proton pump inhibitors without an acceptable indication. An estimated 25% of current long-term PPI users could stop taking the drugs without suffering any adverse consequences.
Compounding the problem, many PPI drugs are now being sold over-the-counter, allowing patients to devise their own treatment schedules. While these OTC versions, like AstraZeneca’s own Nexium 24HR, usually have lower doses than prescription PPIs, they’re also extremely difficult to stop taking.
Bone Fracture Lawsuits
While Nexium kidney failure lawsuits have captured the most attention recently, injured patients may still be able to file their own lawsuits over bone fractures. Today, the label for Nexium clearly states that:
“long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.”
But several patients have come forward with allegations that AstraZeneca “knew or should have known” that Nexium could lead to bone deterioration long before the labeling was updated to reflect medical evidence in 2010. Some older patients have even expressed interest in pursuing claims against the drug’s manufacturer over a potential link between Nexium and osteoporosis, a condition that leaves many prone to debilitating breaks.