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People suffering from persistent heartburn and acid reflux disease may turn to AstraZeneca’s Nexium (esomerazole) for treatment and relief. But, studies show long-term use of this prescription medication can cause fractures, kidney disease, dementia and other serious side effects.
The global pharmaceutical company AstraZeneca produces Nexium and first launched the drug in the early 2000s. The U.S. Food and Drug Administration approved three formulations of Nexium capsules, first in 2001, and again in 2006 and 2008. In 2015, AstraZeneca had a total revenue of $24.7 billion.
Since the the 2001 launch of Nexium, plaintiffs named AstraZeneca in lawsuits for failing to warn consumers of several adverse side effects like an increased risk of bone fracture. New studies released in 2015 and 2016 also link prolonged Nexium use to new severe side effects like kidney disease and dementia, which may draw more lawsuits.
Nexium is a proton pump inhibitor with an active ingredient known as esomeprazole magnesium. This substance reduces the amount of acid in a person’s stomach, effectively treating GERD, acid reflux disease and symptoms of heartburn. Doctors also prescribe Nexium as a preventative medication for people at risk of developing duodenal ulcer disease and gastric ulcers.
Unlike basic antacids, Nexium takes longer to work. Instead of impacting the acid in the stomach immediately, it curbs how much acid the body produces.
In 2005, the FDA approved an injectable version of the drug, Nexium IV. The FDA also approved two formulations of an over-the-counter version of the drug, called Nexium 24HR, in 2014 and 2015.
A 2006 study published in Clinical Gastroenterology and Hepatology found that compared to other proton pump inhibitors, such as Prilosec, Nexium shows a modestly improved increase in effectiveness, especially for people with severe erosive disease.
While Nexium can assist in relieving heartburn discomfort, some users may experience unwanted side effects when taking the drug. The most common side effects of Nexium are headaches, stomach pain, constipation and rash. Patients taking the drug for a shorter period of time, such as less than a year, often have less likelihood of facing severe adverse events.
Women experiencing heartburn discomfort during pregnancy may turn to proton pump inhibitors, like Nexium. The drug is categorized as pregnancy risk C, meaning there have not been well-controlled studies of pregnant woman using the drug. While category C drugs have shown adverse effects on the fetus in animal testing, the benefits outweigh the risks in some cases.
The most common side effects of Nexium include:
Proton pump inhibitors have proven to be very lucrative. The drugs reached $13.9 billion in U.S. sales in 2008. Just two years later, in 2010, Nexium was the second most-prescribed drug nationwide.
Nexium’s cost varies based on a patient’s insurance plan, but the International Federation of Health Plans identified the average price of Nexium in the United States as $215 in 2013.
Financial data shows Nexium’s popularity has remained steady over the past few years. In a 2015 IMS Health study of 2014 prescription drug sales data, Nexium generated the fourth-highest amount in sales — $5.9 billion. The spending was on par with the four years before that — $6.2 billion in 2013, $5.9 billion in 2012, $6.4 billion in 2011 and $6.5 billion in 2010.
Scientists linked prolonged Nexium use to several serious health conditions. While AstraZeneca lists some of these on the safety label, patients might not be aware of other health problems that this medication might cause. The drug and its side effects have been the subject of many scholarly studies within recent years. Three of the most troubling include kidney disease, kidney injury and dementia. Nexium’s label does not specifically warn about these side effects.
According to one February 2016 study published in JAMA Internal Medicine, using Nexium and other proton pump inhibitors is “associated with a higher risk” of chronic kidney disease.
The study examined 10,482 participants for an average of 13.9 years. Some of the participants used proton pump inhibitors like Nexium, and others used H2-receptor antagonists.
The results showed taking proton pump inhibitors such as Nexium were associated with a 20–50% higher risk of developing chronic kidney disease. Those who took two doses of the drugs daily were also associated with a higher risk of developing chronic kidney disease than those who took one dose daily.
One April 2015 study showed people taking proton pump inhibitors like Nexium had a “more than twofold increase” in risk for hospital admission due to acute kidney injury than those who were given the control. Acute kidney injury is an abrupt loss of kidney function and often includes kidney failure.
Roughly 600,000 patients 66 years and older were studied, with equal numbers taking proton pump inhibitors and serving as the control.
Data from the study showed the rate of acute kidney injury was higher amongst those who took the drugs than the control group — 13.49 compared to 5.46, respectively.
In February 2016, German researchers published a study that linked the use of proton pump inhibitors like Nexium to dementia. They studied 73,679 seniors aged 75 and older, all of whom did not have dementia when the study began.
Analysis of patient documents from 2004 to 2011 showed patients who regularly took proton pump inhibitors had a “significantly increased risk” of getting dementia — 44% — than those who didn’t take the drugs.
In addition to these health problems, a number of other issues may affect people who use the medication. The drug's packaging warns users may experience these serious side effects:
Since the medication made it to the market in 2001, thousands of patients around the world experienced serious side effects from Nexium. The label warns consumers of some of these side effects, but not against others — such as kidney problems and dementia.
Patients and their families who experienced these severe side effects from proton pump inhibitors can turn to the legal system to get compensation for their pain and suffering.
Many Nexium injury lawsuits, including one from 2014, resulted in new FDA warnings about the drug, which previously were not listed on the label.
Several individual and class-action lawsuits claimed the manufacturer, AstraZeneca, and other groups involved with Nexium production failed to warn patients of all the risks associated with taking the drug.