Generically known as Esomerprazole, Nexium is a next-generation proton pump inhibitor (PPI) now available over the counter. Doctors have prescribed it to treat heartburn and gastroesophageal reflux disease (GERD), in addition to stomach ulcers, ulcers in the small intestine, and esophageal inflammation.
Yet, data from several studies has associated Nexium use with bone fractures, severe kidney disease, and renal failure. In fact, long-term usage is believed to triple a patient’s risk of kidney inflammation, also known as nephritis.
When introduced in 2001, Nexium was said to be better than Prilosec, its predecessor, and turned into a top-seller for manufacturer AstraZeneca by 2004. By 2013, it was bringing in $6.1 billion in global sales.
However, recent research has found that its common prescription – assumed to be much higher because of unmonitored over-the-counter usage – could be harmful to patients. A 2016 study published in the Journal of the American Society of Nephrology indicated that proton pump inhibitors (PPIs) in general increase patients’ risks of kidney disease and failure: Patients, in fact, are 28 percent more likely to develop chronic kidney disease, especially if a PPI is taken long term.
Another study out that year, published in JAMA Internal Medicine, found that patients taking Nexium and other PPIs may have their risk of chronic kidney disease increase anywhere from 20 to 50 percent. Out of the 20,000 individuals researchers analyzed over a 13-year period, data indicated:
- Patients’ decline of kidney function increased 32 percent.
- Patients’ risk of developing a new case of kidney failure increased 28 percent.
- Patients taking PPIs, when compared to a similarly sized group taking H2 blockers, were more likely to develop chronic kidney conditions over this period.
This study further identified that patients continue to be prescribed PPIs without a definite reason and may be kept on it, even if the individual’s condition changes. Also, more individuals are now at risk for developing kidney disease, as Nexium can be purchased without a prescription.
Once a patient develops chronic kidney disease, the condition is not reversible and may require regular medical treatments, like dialysis, transplants, or grafts.
Because of these recent studies, patients given Nexium have filed lawsuits against AstraZeneca, alleging the drug directly caused chronic kidney disease, acute kidney injury, renal failure, kidney failure, or acute interstitial nephritis. In court documents, plaintiffs claim the manufacturer failed to warn physicians about these risks, and that if they had known, they would have selected a different PPI. Further, they allege AstraZeneca knew about these risks as early as 2004 but failed to notify physicians.
Bone Loss and Fractures
Earlier lawsuits concerning Nexium claim the PPI contributed to deteriorating bones and fractures. Initially, a British study published in the Journal of the American Medical Association in 2006 shed light on this concern: Patients older than 50 years of age taking Nexium and other PPIs had a greater risk of hip fractures. Particularly, post-menopausal women taking PPIs have a 25-percent or higher chance of experiencing a fracture, especially to the spine or wrist area.
By 2010, the FDA issued a warning regarding PPI usage and fracturing, especially if the patient takes the drug at high doses for longer than a year, and requested manufacturers update their labels. Supporting their decision, the FDA examined several studies: Six determined that PPI usage at higher doses increased patients’ fracture risks, and two others identified a similar concern for extended usage. Most involved patients 50 years of age and older.
Other studies from the past 10 years have associated Nexium and PPI usage with additional health concerns:
- Heart Attacks: A PLOS One article found that Nexium usage may increase patients’ heart attack risks anywhere from 16 to 21 percent, even if an individual has no history of heart disease.
- Birth Defects: Data from 2010 shows that PPIs may be behind cardiac-related birth defects when an infant is exposed during pregnancy.
- Dementia: Data shows that older patients taking PPIs may have a 44-percent greater chance of developing dementia.
- Rebound Acid Hypersecretion: A 2009 study from the University of Copenhagen found that patients taking Nexium and other PPIs may develop the same problems these drugs are designed to treat, which makes stopping usage far more difficult. This condition may develop even if a patient has taken a PPI for just two months and may last for three months after the patient discontinues taking the drug.
Along with these risks, AstraZeneca had been hit with a $20 million class action lawsuit over false claims. The plaintiffs alleged the manufacturer made inaccurate statements within its marketing materials, which claimed Nexium was more effective than Prilosec in treating acid reflux. Further, the lawsuit found doctors received kickbacks for prescribing this PPI.
Had you or a loved one experienced any of these side effects after taking Nexium? Trantolo & Trantolo believes all patients should be provided with full information to make accurate choices about their health, and manufacturers being less than forthright must be held accountable. If you think you have a claim, bring it to the attention of one of our dangerous drug attorneys today.