In 2001, the American public was given access to a new prescription heartburn medication marketed as Nexium (esomeprazole magnesium). Produced by drug company AstraZeneca, Nexium is a proton pump inhibitor that reduces stomach acids, offering relief for people who suffer from symptoms of gastroesophageal disease (GERD). Esomeprazole is also effective in relieving other conditions stemming from excessive stomach acid, such as Zollinger-Ellison syndrome and esophagitis. A less concentrated version, known as Nexium 24-hour, is sold over the counter for individuals who suffer from frequent heartburn.
Generic Nexium became available in early 2015, when U.S. health regulators approved the first generic esomeprazole magnesium capsules. In addition to GERD symptoms, Nexium and its generic counterpart are also approved to lower the risk of gastric ulcers linked to chronic use of nonsteroidal anti-inflammatory drugs such as Aleve.
Despite its widespread popularity for the treatment of GERD, Nexium has been the topic of product liability litigation, based on claims that the proton pump inhibitor poses serious health risks such as kidney failure and bone fractures, and that AstraZeneca marketed a dangerous drug without adequate warnings.
Nexium side effects
Nexium, which is indicated for children age 1 and older, has been associated with the following common side effects:
- Stomach pain
- Abdominal gas
- Dry mouth
More serious reactions to Nexium warrant immediate medical attention. These side effects include:
- Irregular heart beat
- Jittery feeling
- Muscle cramps or spasms
- Choking feeling
- Watery diarrhea
- Loss of bone density
- Kidney problems
All types of proton pump inhibitors, including Prevacid and Prilosec, are linked to decreased magnesium absorption. Several studies have demonstrated that PPIs are also associated with much more sinister problems, prompting the FDA to caution against prolonged use or high doses of proton pump inhibitors like Nexium.
Nexium kidney failure
Research regarding proton pump inhibitors and kidney failure published in JAMA Internal Medicine made headlines in early 2016. Scientists found that PPIs were linked to a 20 to 50 percent increased risk of chronic kidney disease. The team followed 10,482 patients for 14 years, comparing people who used proton pump inhibitors to those who took H2 receptor antagonists (like Tagamet) to non-users. The findings were then validated against a separate study group of more than 250,000 – taken from a rural health care system.
“The study doesn’t prove that P.P.I.s cause kidney disease,” said the study’s lead author, Dr. Morgan E. Grams of Johns Hopkins. He added “…we don’t want to cause alarm. P.P.I.s are great medicines, and sometimes lifesaving… One approach for patients who require a long course of P.P.I.s would be to routinely monitor their kidney function.”
Even more recently, research published in the Journal of the American Society of Nephrology shows the inherent dangers of long-term antacid medications like Nexium. Utilizing data from the U.S. Department of Veterans Affairs, the findings showed that patients who took proton pump inhibitors had a 96 percent increased risk of kidney failure and 25 percent greater risk of developing chronic kidney disease.
Given that 15 million Americans use PPIs and Nexium is the number one seller, this research has generated apprehension among the medical community. “I think it’s a pretty big concern,” Adam Schoenfeld, an internal medicine resident at the University of California, told NPR. Schoenfeld points out that many prescriptions for PPIs are inappropriate, according to studies, thus putting patients at risk for a range of serious long-term side effects.
Nexium bone fractures
After reviewing several studies that demonstrated a causal relationship between PPIs and bone fractures, the FDA issued a drug safety communication in 2010. According to the agency, six of the seven reports analyzed reported an increased risk of hip, wrist and spine fractures with the use Nexium and other proton pump inhibitors. The research suggested that patients age 50 and older and those who took high doses of the medication for one year or longer were most vulnerable to bone fractures when taking Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex or Vimovo. The product labeling was updated with language to indicate fracture risks.
Since that time, Nexium patients who have suffered rapid bone deterioration and an unusual incidence of fractures have begun taking their claims to court, suing for medical expenses, lost income, as well as pain and emotional suffering.
When a patient suffers physical injury caused by a prescription medication that was marketed without proper warnings, he or she may be entitled to substantial compensation through litigation. The first wave of Nexium lawsuits was filed after the FDA label change regarding Nexium bone fracture risks.
Plaintiffs argue that AstraZeneca:
- Failed to provide adequate warnings about Nexium risks
- Negligently marketed the drug in a deceitful or illegal manner
- Knowingly concealed risks from the medical community and consumers
- Designed and manufactured a dangerous medication
Nexium bone fracture lawsuits were consolidated as multidistrict litigation in California federal court. However, the judge overseeing the proceedings entered a summary judgment in favor of the defendants in 2014, closing the MDL.
Despite this, AstraZeneca still faces legal action throughout the country, brought by plaintiffs who charge that Nexium has caused a host of health problems, including osteoporosis, bone fractures, kidney failure and heart problems.
Nexium kidney damage resources
- JAMA Internal Medicine, Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease http://archinte.jamanetwork.com/article.aspx?articleid=2481157
- Journal of the American Society of Nephrology, Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD http://www.ncbi.nlm.nih.gov/pubmed/27080976
- NPR.org, Popular Acid Reflux Drugs Are Linked To Kidney Disease Risk http://www.npr.org/sections/health-shots/2016/01/11/462423759/popular-acid-reflux-drugs-are-linked-to-kidney-disease-risk
- FDA, Proton Pump Inhibitors (PPI): Class Labeling Change including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213321.htm
- Drugs.com, Nexium Side Effects http://www.drugs.com/sfx/nexium-side-effects.html
- Medscape, Long-term Consequences of Chronic Proton Pump Inhibitor Use http://www.medscape.com/viewarticle/820136_2