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Nexium & Prilosec Lawsuits

Nexium & Prilosec are drugs called proton pump inhibitors (PPIs). They are used to treat gastroesophageal reflux disease (GERD), by reducing the amount of acid in a person’s stomach.

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What Do We Know About the Nexium & Prilosec Lawsuits

Nexium Prilosec Lawsuit

More than 13,000 lawsuits have been filed against the manufacturers of Nexium and Prilosec by individuals who have suffered injuries as a result of taking these two proton pump inhibitor (PPI) medications. The lawsuits are presently combined before a federal judge in New Jersey where all of the national discovery and evidence gathering is taking place.

The Key Legal Issue

The manufacturers of Nexium and Prilosec failed to warn doctors and patients that use of its medication could cause kidney and renal failure, including acute interstitial nephritis (AIN).

In the court filings, lawyers argue the following:

  1. Nexium and Prilosec are defective and unreasonably dangerous.
  2. The manufacturers (including AstraZeneca, Proctor & Gamble, and Pfizer) were negligent in the production of the drug.
  3. The manufacturers failed to properly test the medication, and failed to warn doctors and patients of certain risks.
  4. The manufacturers concealed evidence of the dangers from the government and the public, and misrepresented the safety of the drug in its marketing material.
 

Nexium and Prilosec Injuries & Side Effects

The most serious potential side effects caused through the use of Nexium & Prilosec are strokes, bone fractures, acute kidney injury (AKI), renal failure, and heart damage.

People who take multiple daily doses for a long period of time (a year or longer), especially those 50 years of age or older, have an increased risk of fractures of the hip, wrist, and spine. Additionally, people who use the drugs appear to have a 20-50% higher risk of chronic kidney disease compared with nonusers, and a 20-30% increased risk for stroke.

Nexium & Prilosec User Warning

Nexium and Prilosec users "are at increased risk for heart attack, stroke and renal failure,” says Dr. John P. Cooke, Houston Methodist Research Institute.

It’s very important to tell your doctor if you experience any of the following problems: (i) kidney disease; (ii) osteoporosis; (iii) low bone mineral density (osteopenia); (iv) numbness in the face, arm or leg; (v) confusion or trouble speaking; (vi) loss of vision; (vii) dizziness; (viii) difficulty walking; (ix) severe headache; or (x) low levels of magnesium in your blood.

 

Cardiovascular diseases and heart attacks

According to a large clinical trial called PLOS ONE, the use of Nexium and other PPIs has been associated with an estimated increase in heart attack risk of 16-21%. These drugs can reduce the production of a substance that protects blood vessels. The internal lining of the vessels is then damaged, increasing the formation of dangerous blood clots and other cardiovascular diseases.

 

Chronic kidney disease

PPIs are linked with a 20 to 50 percent higher risk of chronic kidney disease (CKD), as demonstrated by a large study published in the JAMA Internal Medicine journal. The risk is higher in patients who took higher doses of these medications. CKD causes a gradual loss of kidney function that may also lead to renal failure.

Symptoms of Chronic Kidney Disease

Symptoms of CKD include: (1) buildup of fluid in the lungs; (2) difficulty urinating; (3) electrolyte imbalances; (4) extreme fatigue; (5) heartbeat abnormalities; (6) high blood pressure; (7) nausea, vomiting or loss of appetite; and (8) swelling in the legs, ankles or feet.
 

Ischemic stroke

An ischemic stroke occurs when the flow of blood and oxygen to the brain is reduced, causing the brain cells and tissue to die. PPIs are linked to a 20-30% increased risk of strokes depending upon the dosage the person is taking per day.

 

Gastric tumors, bone fractures and anemia

Nexium and Prilosec do more than just reduce gastric acid, they also reduce the secretion of several other substances produced by stomach cells. These specific substances are required for the proper absorption of important nutrients such as Vitamin C, Vitamin B12, calcium, and magnesium.

Long-term use of PPIs has been associated with iron deficiency anemia, hypomagnesemia, and pernicious anemia. The use of PPIs for extended periods may also reduce bone strength, increasing the risk of hip, spine, and wrist fractures.

PPIs also indirectly increase the production of other substances such as gastrin. Hypergastrinemia has been associated with an increased risk of gastric tumors as well as with other cancer malignancies in patients affected by gastroesophageal reflux disease (GERD).

 

Pneumonia, diarrhea and systemic infections

Proper gastric acid secretion is critical to our health. PPIs reduce acid secretion by up to 99%, which is much more than is usually required by most patients, especially if these drugs are taken for extended periods of time.

Hydrochloric acid is, in fact, a barrier to sterilize the food we eat, killing most microbes such as bacteria and viruses. Without stomach acid, patients are at a greater risk of serious infections including Clostridium difficile enteritis, diarrhea, and pneumonia.

 

Risk of Dementia

A study published in the journal JAMA Neurology showed that regular use of PPIs was linked with a 50% increased risk of dementia in elderly patients. Researchers analyzed data from 74,000 patients over a period of 7 years, and explained that in those countries where PPIs are available as over-the-counter medications (such as the United States), the risk may be even higher.

 

Nexium & Prilosec Lawsuit Settlement Amounts

Nexium Prilosec Settlements

As of April 4, 2023, there have been no large mass tort settlements involving Nexium or Prilosec and the potential link to kidney injuries.

In 2016, AstraZeneca paid the United States Department of Justice a $7.9 million penalty for engaging in a kickback scheme involving the sale of Nexium and Prilosec.

In 2015, AstraZeneca settled a national class action involving deceptive marketing of Nexium for the sum of $20 million.

In 2003, AstraZeneca faced allegations by the European Commission that the company provided false and misleading information in order to protect its patent on Losec (sold in the U.S. as Prilosec). After a two-year investigation, the Commission ordered AstraZeneca to pay a fine of €53 million (approximately $67.5 million USD).

 

Nexium & Prilosec Recalls & Warnings

As of this time, there has not been a recall of Nexium or Prilosec related to kidney damage. However, the investigation into these drugs, from a legal standpoint, are still at the early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that will lead to a recall.

 

What is the Purpose of Nexium & Prilosec?

Nexium & Prilosec are drugs called proton pump inhibitors (PPIs). They are used to treat gastroesophageal reflux disease (GERD), by reducing the amount of acid in a person’s stomach. They also may be prescribed to heal acid-related damage to the lining of the esophagus; to reduce stomach ulcers; to treat stomach infections; to lessen heartburn and acid indigestion; and to treat Zollinger-Ellison syndrome.

Approximately 15 million Americans use PPIs. However, as many as 25% of long-term users could stop taking the medication without suffering increased heartburn or acid reflux, according to researchers at Johns Hopkins University.

 

Are Nexium and Prilosec the Same Drug

Esomeprazole (Nexium) is a “mirror drug”, meaning that is extremely similar to omeprazole (Prilosec), just like the left hand is the “mirror image” of the right hand. Technically they could be considered the same drug. Shortly after Prilosec’s patent ended, however, AstraZeneca obtained the FDA’s approval to market Nexium as a new drug just before the market was flooded with generic medications.

Many speculated that the pharmaceutical giant manufactured the new medication in order to maintain their revenues, since in the early 2000s Prilosec was the top-selling prescription medicine in the U.S., with yearly sales of $4.1 billion.

Esomeprazole and other PPIs are among the most overprescribed medications in the entire world, and they’re also grossly overpriced, especially in the United States. According to the American Society of Health-System Pharmacists, generic omeprazole is sold at about $1 per single dose, while esomeprazole’s price is usually 7 to 15 times higher.

Dr. Marcia Angell, the former editor-in-chief of the New England Journal of Medicine, accused AstraZeneca of distorting the results of the studies that allegedly demonstrated esomeprazole’s superiority over omeprazole to artificially overcharge the American consumers.

 

Nexium & Prilosec Lawsuit News

Heartburn medications causing serious health problems:

"With research showing that anywhere from 30 to 70 percent of PPI users don’t need the drugs at all, Dr. Adriane Fugh-Berman points a finger at gastroesophageal reflux disease as being a driving force behind PPI overuse. . . . Eventually, nephrologist and researcher Dr. Morgan Grams of Johns Hopkins, says she started to notice that most of her patients who had come in with chronic kidney disease had been using PPIs." Reported in ABC10 - Nexium Prilosec Health Issues

Popular heartburn medication may increase ischemic stroke risk:

A popular group of antacids known as proton pump inhibitors, or PPIs, used to reduce stomach acid and treat heartburn may increase the risk of ischemic stroke, according to preliminary research presented at the American Heart Association's Scientific Sessions 2016. Reported in EurekAlert - Nexium Prilosec & Stroke

Nexium and Prilosec Linked to Kidney Damage, Heart Damage and Bone Fractures:

Long-term use of a common type of medication used to treat heartburn, acid reflux, and ulcers may lead to an increased risk of kidney disease and kidney failure, new research shows. The study, published in the Journal of the American Society of Nephrology, adds to prior research that suggests proton-pump inhibitors (PPIs), a group of drugs which reduces gastric acid production, can lead to serious kidney damage. Reported in CBS News - Nexium Prilosec Bone Fractures

Common heartburn drugs linked with kidney disease:

People who use proton pump inhibitors (PPIs) have a 20 percent to 50 percent higher risk of chronic kidney disease compared with nonusers, said lead author Dr. Morgan Grams, an assistant professor of epidemiology at Johns Hopkins University in Baltimore. . . . Use of the prescription heartburn drugs already has been linked to short-term kidney problems such as acute kidney injury and an inflammatory kidney disease called acute interstitial nephritis, Grams said. Newer studies now show a link between the drugs and chronic kidney disease, in which the kidneys lose their ability to filter blood effectively. Over time, chronic kidney disease can lead to kidney failure, forcing someone to undergo regular dialysis and possibly a kidney transplant, according to the U.S. National Institutes of Health. Reported in CBS News - Kidney Disease

Heartburn Drugs Tied to Higher Kidney Disease Risk:

A common type of heartburn medication called proton pump inhibitors (PPIs) seem to be linked with increased risk of chronic kidney disease, two new studies suggest. Prilosec, Nexium and Prevacid belong to this class of drugs, which treat heartburn and acid reflux by lowering the amount of acid produced by the stomach. . . . They found that PPI users were up to 50 percent more likely to develop chronic kidney disease than non-PPI users, even after adjusting for differences between the two groups. Reported in WebMD - Heartburn Drug Kidney Disease

Popular Acid Reflux Drugs Are Linked To Kidney Disease Risk:

People who take certain popular medicines for heartburn, indigestion and acid reflux may want to proceed more cautiously, researchers reported Monday. The drugs, known as proton-pump inhibitors (PPIs), appear to significantly elevate the chances of developing chronic kidney disease, according to a study involving more than 250,000 people. An estimated 15 million Americans use PPIs, which are sold by prescription and over-the-counter under a variety of brand names, including Nexium, Prilosec and Prevacid. Reported in NPR - Acid Reflux Drug Kidney Risk

Popular heartburn medication linked to chronic kidney disease:

Widely popular heartburn medications that block the secretion of acid into the stomach are associated with higher rates of chronic kidney disease, according to a new study by Johns Hopkins University researchers released Monday. The research raises more questions about commonly used drugs such as Nexium, Prilosec and Prevacid, which had long been considered effective with few side effects. In June, an unusual data-mining project by Stanford University researchers revealed evidence linking the medications to a greater risk of heart attacks. Previous analyses have linked the medications to bone fractures, gut infections and other health problems. Reported in Washington Post - Chronic Kidney Issues

 

FDA and Scientific Studies Regarding Nexium & Prilosec

Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease

Proton pump inhibitors (PPIs) are among the most commonly used drugs worldwide and have been linked to acute interstitial nephritis. Less is known about the association between PPI use and chronic kidney disease (CKD). . . . Proton pump inhibitor use is associated with a higher risk of incident CKD. Reported in Journal of American Medical Association - PPIs & Kidney Disease

PPIs and kidney disease: from AIN to CKD

Proton pump inhibitors (PPIs) are commonly prescribed and available over-the-counter, and are taken by millions of patients around the world, often for many months to years. While PPIs have an excellent overall safety profile, concerns have been raised about adverse renal events, specifically their association with acute interstitial nephritis (AIN). While only a small proportion of patients develop AIN from PPIs, these drugs are now a common cause of drug-induced AIN in the developed world due to their widespread and prolonged use. Reported in Journal of the American Society of Nephrology - PPIs Kidney Issues

Proton pump inhibitors are associated with increased risk of development of chronic kidney disease.

Use of proton pump inhibitors is associated with increased risk of development of CKD and death. With the large number of patients being treated with proton pump inhibitors, healthcare providers need to be better educated about the potential side effects of these medications. Reported in BBC Nephrology - Chronic Kidney Disease

Overprescribing proton pump inhibitors

Proton pump inhibitors are one of the most frequently prescribed classes of drug in the world because they combine a high level of efficacy with low toxicity. Yet studies consistently show that proton pump inhibitors are being overprescribed worldwide in both primary and secondary care. Between 25% and 70% of patients taking these drugs have no appropriate indication. Reported in British Medical Journal

Some heartburn drugs may boost risk of heart attack, study finds

A large data-mining study carried out by investigators at the Stanford University School of Medicine has linked a popular class of heartburn drugs to an elevated risk of heart attack. Reported in Stanford Medical Journal

Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs

In March 2011, the U.S. Food and Drug Administration published a safety announcement, warning that use of Prilosec and other proton pump inhibitors for periods of 12 months or longer may result in low serum magnesium levels (hypomagnesemia), resulting in potentially fatal cardiovascular and nervous system dysfunction. Reported in FDA Safety Communication - PPIs & Hypomagnesemia

Combination Use of Clopidogrel and Proton Pump Inhibitors Increases Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease: A Meta-Analysis.

The combination use of clopidogrel and certain types of PPIs (omeprazole, lansoprazole, esomeprazole, pantoprazole) increases the risk of major adverse cardiovascular events in patients with coronary artery disease. Reported in Journal of Cardiovascular Pharmacology

FDA Issues Warning on Acid Reflux Drugs

In February 2012, the U.S. Food and Drug Administration issued a warning of a link between the use of omeprazole (Prilosec) and esomeprazole (Nexium) and an increased risk of infection from clostridium difficile, resulting in serious diarrhea. Reported in MedPage - PPIs & Clostridium Difficile

 
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