Nexium Lawsuit
Update: Study Finds Increased Risk of Death with PPI Heartburn Medications
July 5, 2017 – Proton pump inhibitors have been linked to a 25% greater risk of death compared to patients who took H2 blockers, according to a study published Monday in BMJ. The study also found that PPI use was linked to a 15% increased death rate compared to patients who took another kind of acid suppressor other than H2 blockers, and that the death rate was 23% higher among PPI users compared to people who took no such medications.
What’s the Problem?
AstraZeneca’s popular heartburn medication Nexium has been linked to serious side effects including chronic kidney disease, acute interstitial nephritis, heart attack, stroke, bone fractures and more. Some of these side effects were not warned about on the product’s labeling, and it now appears that the manufacturer placed its desire for profits before consumer safety by failing to adequately warn about the risks associated with Nexium.
What is Nexium?
Nexium (generic: esomeprazole) is a proton pump inhibitor (PPI) drug used to treat stomach and esophagus problems including acid reflux and ulcers. The medication works by decreasing the amount of acid produced by the stomach, which helps relieve symptoms such as heartburn, difficulty swallowing and persistent cough. Nexium was approved by the U.S. Food & Drug Administration (FDA) in February 2001.
Nexium and Chronic Kidney Disease (CKD)
The Journal of the American Medical Association (JAMA) published a study in February 2016 which found that patients who took proton pump inhibitors like Nexium had a 20-50% increased risk of developing chronic kidney disease (CKD) compared to patients who took other types of heartburn medications. The researchers looked at the medical records of more than 10,000 PPI users who were followed for an average of 13 years, and determined that the longer the medications were taken, the greater the risk of CKD.
Another study published in the Journal of the American Society of Nephrology (JSAN) in April 2016 found that long-term proton pump inhibitor use may increase the risk of chronic kidney disease and end-stage renal disease (ESRD). Researchers compared PPIs to histamine H2 receptor blockers (Pepcid, Tagamet, Zantac), and identified a 28% increased risk of CKD associated with proton pump inhibitors.
Acute Interstitial Nephritis
Research published in BMC Nephrology in July 2013 stated that previous studies and numerous biopsy-confirmed case reports have identified links between PPI use and acute interstitial nephritis (AIN). In 2006, the New England Journal of Medicine (NEJM) released information about a case series and literature review that found an association between PPIs and the development of nephritis. Although many of these patients experienced some degree of recovery of renal function, others suffered permanent kidney damage as a result of proton pump inhibitor use.
Heart Attack
A June 2015 study published in PLOS ONE found an increased risk of heart attack among patients who took proton pump inhibitors. The research included findings from 2 separate studies that examined the medical records of nearly 3 million patients, and determined that PPI use was associated with a 16 to 21% increased risk of heart attack.
Bone Fractures
In December 2006, a study published in the Journal of the American Medical Association (JAMA) found that long-term PPI use may increase the risk of hip fractures in elderly patients. The researchers determined that the medications interfere with calcium absorption through induction of hypochlorhydria and reduce bone resorption through inhibition of osteoclastic vacuolar proton pumps.
FDA issued a Drug Safety Communication in May 2010 regarding an increased risk for fractures of the hip, wrist and spine associated with use of proton pump inhibitors. Patients at greatest risk for fractures were those who took PPIs for one year or more, according to the FDA.
PPIs Can Prematurely Age Blood Vessels, Study Finds
Nexium may have the potential to cause silent damage to blood vessels, increasing the risk of heart attack and stroke, according to a May 2016 study published in Circulation Research. Researchers linked esomeprazole to rapid aging of blood vessel cells, which may damage their ability to function, making those who use the medication more likely to have a heart attack or stroke.
“Our finding that the lining of blood vessels is impaired by proton pump inhibitors is a unifying mechanism for the reports that PPI users are at increased risk for heart attack, stroke and renal failure,” said John Cooke, Houston Methodist Research Institute chair of cardiovascular sciences and lead author of the study. “They {PPIs} are being used ubiquitously, for long periods of time. They aren’t being used as originally approved.”
Rebound Acid Hypersecretion (RAHS)
A July 2009 study published in Gastroenterology found that PPI use may cause “rebound acid hypersecretion” (RAHS), or a recurrence of acid-related symptoms, after 8 weeks of treatment. This finding indicates that patients may become dependant on the medications.
Birth Defects
In November 2010, proton pump inhibitors were linked to cardiac heart defects in babies born to mothers who took the drugs during pregnancy. FDA concluded that no statistically significant risk had been shown; however, Nexium’s parent drug Prilosec is listed in Pregnancy Category C, which means that animal studies have shown evidence of fetal risk.
Hypomagnesemia
FDA issued a Drug Safety Communication in March 2011 regarding an risk for the development of low magnesium levels (hypomagnesemia) with symptoms of neurological, muscular and cardiac effects associated with PPI use. In approximately 25% of cases reviewed by the agency, magnesium supplementation did not improve low serum magnesium levels and proton pump inhibitors had to be discontinued.
Nexium Side Effects
- Acute interstitial nephritis (inflammation of the kidneys)
- Acute kidney injury
- Chronic kidney disease (CKD)
- Kidney failure (end-stage renal disease or ERSD)
- Cardiac disorders
- Heart attack
- Stroke
- Artery damage
- Rapid aging of blood vessel cells
- Bone fractures (hip fracture, wrist fracture, spine fracture)
- Broken bones
- Rebound acid hypersecretion (RAHS)
- Low magnesium levels (hypomagnesemia)
- Gut infections
- Clostridium difficile infection
- Community-acquired pneumonia
- Dementia
- Erectile dysfunction (ED)
- Severe allergic reactions
- Birth defects in babies exposed to Nexium in the womb
- And more
Proton Pump Inhibitors Overprescribed, Used for Unclear Conditions
Researchers indicate that up to 70% of patients may have been issued prescriptions for PPIs without a clear medical reason, and many have never been taken off the drugs even though their conditions may have changed. Additionally, Nexium is now available as an over-the-counter (OTC) medication and many more patients are using it without the advice of a doctor, compounding the risks associated with the drug.
Is There a Class Action?
In August 2013, a consumer fraud class action lawsuit was filed against AstraZeneca alleging deceptive marketing practices with Nexium. Plaintiffs alleged that AZN violated a Massachusetts state law by illegally marketing Nexium as superior to Prilosec. The complaint requested that the manufacturer pay restitution to purchasers for amounts they allegedly overpaid, to award money damages, or to grant other relief.
Lawsuit Allegations
Previous lawsuits filed over injuries allegedly caused by Nexium have accused AstraZeneca of:
- Manufacturing a dangerous and/or defective medication
- Failing to provide adequate warnings on the risks of Nexium
- Knowingly hiding dangers of the drug from the public and medical communities
- Marketing Nexium in an illegal and/or improper manner
PPIs Linked to Increased Risk of Pneumonia in Dementia Patients
April 5, 2017 – Dementia patients who take proton pump inhibitors have an 89% increased risk of developing pneumonia compared to dementia patients who don’t use the medications, according to a study published last month in the Journal of the American Geriatrics Society. Independent risk factors for pneumonia included age, male gender, underlying cerebrovascular disease, chronic pulmonary disease, congestive heart failure, diabetes mellitus, and antipsychotic use.
Nexium Timeline
2001 – FDA Approval
Nexium approved by the U.S. Food & Drug Administration (FDA).
2006 – NEJM Journal Watch information released
NEJM Journal Watch releases information about a case series and literature review that found a link between proton pump inhibitor use and the development of acute interstitial nephritis (AIN).
2006 – JAMA study
JAMA study indicates that long-term PPI use may increase the risk of hip fractures in elderly patients.
2009 – Gastroenterology study
Gastroenterology study finds that PPI use may cause a “rebound” of acid-related symptoms, leading to some patients becoming dependant on the medications.
2010 – FDA issues Drug Safety Communication
FDA issues Drug Safety Communication regarding an increased risk for fractures of the hip, wrist and spine associated with the use of PPIs.
2010 – NEJM study published
The New England Journal of Medicine (NEJM) publishes a study indicating that babies born to mothers who use PPIs during pregnancy may have an increased risk of cardiac birth defects.
2011 – FDA issues Drug Safety Communication
FDA issues Drug Safety Communication regarding an increased risk of low magnesium levels (hypomagnesemia) with symptoms of neurological, muscular and cardiac effects associated with PPI use.
2013 – BMC Nephrology Research published
Research published in BMC Nephrology states that previous studies and numerous biopsy-confirmed case reports have identified links between proton pump inhibitor use and acute interstitial nephritis (AIN).
2013 – Class action lawsuit filed
Class action lawsuit filed against AstraZeneca alleging deceptive marketing practices with Nexium.
2015 – PLOS ONE study findings
PLOS ONE study finds that PPI users had a 16-21% increased risk of heart attack compared to non-users.
2016 – JAMA study findings
JAMA study finds that PPI users had a 20-50% increased risk of developing chronic kidney disease (CKD) compared to patients who took other types of heartburn medications.
2016 – Journal of the American Society of Nephrology study published
Study published in the Journal of the American Society of Nephrology (JASN) indicates that long-term PPI use increases the risk of CKD by 28% compared to histamine H2 receptor blockers (Pepcid, Tagamet, Zantac).
2016 – Circulation Research study published
Study published in Circulation Research finds that Nexium can cause silent damage to blood vessels, increasing the risk of heart attack and stroke.