Researchers have linked the popular heartburn drug Prilosec to an increased risk for kidney disease. Along with other proton pump inhibitor (PPI) drugs, approved to treat acid reflux disease and gastrointestinal ulcers, Prilosec has been found to boost the risk for chronic kidney disease and kidney failure. But the drug’s manufacturer, AstraZeneca, hasn’t addressed this potential risk publicly – and its warning label doesn’t mention chronic kidney disorders once.
Today, Prilosec patients have begun to consider filing lawsuits over severe cases of renal impairment, debilitating conditions they believe were caused by the heartburn medication.
While this litigation is currently closed, learn more from a Proton Pump inhibitor attorney.
This isn’t the first time AstraZeneca has stumbled into legal trouble over Prilosec. After the drug was linked to an increased risk for bone fracture, dozens of patients filed suit in federal courts. In a series of revelatory complaints, people who had broken wrists, hips and vertebrae accused the British-Swedish multinational of concealing medical evidence from the public.
AstraZeneca has already been hit by several lawsuits for its other proton pump inhibitor drug, Nexium, which has also been linked to increased risks of chronic kidney disease and renal failure. Now, patients have leveled strikingly similar allegations against the company over Prilosec’s association with kidney impairment. In their minds, it’s all about warnings.
While the drug’s warning label mentions a potential risk for acute kidney injuries, there’s no information about chronic kidney disease or kidney failure. That’s a major problem, patients say, one that prevents doctors and regular people from making fully-informed choices about the drugs they prescribe or take.
Prilosec’s warning label includes one reference to a kidney risk: acute interstitial nephritis. This form of renal inflammation is something like an allergic reaction. It’s most often caused by an adverse reaction to a drug. A chronic form of the inflammation disorder also exists, but Prilosec’s warning information only mentions the acute form.
Both acute and chronic interstitial nephritis can lead to kidney failure, according to the US National Library of Medicine.
Prilosec users appear to be between 20% and 50% more likely to suffer chronic kidney disease, according to a recent study out of Baltimore’s Johns Hopkins University. University health scientists used data from two large patient information databases, one from a national study on artery health and another from a Pennsylvania-based health care system, to arrive at their results.
In their study, the researchers found that, as the dosage of Prilosec increased, the risk for chronic kidney disease increased as well. In the words of lead author Dr. Morgan Grams, an assistant professor at Johns Hopkins, “that suggests that perhaps this observed effect is real.” Grams spoke with CBS News in January 2016.
Chronic kidney disease isn’t the only risk associated with Prilosec. In fact, CKD can lead to even more debilitating renal impairment – including kidney failure. In a review of data from the Department of Veterans Affairs, government researchers discovered that proton pump inhibitors nearly doubled the risk for kidney failure compared to other heartburn medications.
Alongside PPI users, the study looked at the risk of kidney disease in a group of people taking H2 blockers, a class of antacids that includes Zantac. This was an attempt to deal with concerns that people who need heartburn drugs may be at an increased risk for renal impairment as a matter of course, regardless of the effects of any one drug. While both groups “tended to be equally unhealthy,” CBS News reports, proton pump inhibitor users were more than 39% more likely to experience chronic kidney disease than H2 blocker users.
As in the Johns Hopkins study, the researchers identified a “graded association,” in which the risk of kidney conditions increased as drug dosage increased – adding strong support to the link between proton pump inhibitors and renal disorders.
“If you don’t need these medicines, you shouldn’t take them,” says Kenneth DeVault MD, chair of medicine at the Mayo Clinic. But putting this reasonable caution into practice has been difficult.
Proton pump inhibitors are massively over-prescribed. While the drugs are only approved for very specific gastrointestinal conditions, doctors have begun to rely on them as a catch-all treatment for any disorder that seems connected to gastric acid, the fluid which they inhibit in the intestines.
This is a complex problem, one that researchers have long noted. For one thing, proton pump inhibitors are extremely effective at controlling the amount of gastric acid in a patient’s stomach. This “effectiveness […] has led to overutilization in multiple treatment areas,” doctors from Michigan wrote in 2012, “exposing patients to an increasing number of potential risks.”Surges in gastric acid are of particular concern. While proton pump inhibitors nearly eliminate the production of gastric acid, most patients experience a spike in production after being taken off the drugs. This can be deeply uncomfortable, and some patients choose to go right back on the drugs after ceasing treatment. In doing so, they become locked in a vicious cycle – inadvertently falling into prolonged PPI use.
The dilemma is only exacerbated by the wide availability of over-the-counter formulations, like Prilosec OTC, which consumers can use to treat themselves.
Legal experts say that any patient who was prescribed Prilosec and suffered from chronic kidney disease or kidney failure may be eligible to file suit. Widows and widowers who lost their loved ones to a renal disorder may also be able to pursue legal action, in the form of a wrongful death lawsuit.
Renal impairment can be debilitating. Many patients have been forced into dialysis treatment centers; others have required kidney transplants. But emotional support is also a priority. Any serious medical problem can cause psychological trauma, to say nothing of the effect it has on friends and family.
Facing soaring medical expenses, pursuing compensation may be the only way to stay above water for many families.
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