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Prilosec Lawsuit Update
Kidney & Renal Injury Lawyer

The proton pump inhibitor (PPI) heartburn drug Prilosec has been linked to serious side effects including chronic kidney disease (CKD), renal failure, bone fractures, heart attack and more.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Free and Confidential Evaluation of Prilosec Legal Matter: If you or someone in your family has suffered from kidney damage or any serious side effects as a result of taking the prescription drug Prilosec, it is crucial that you immediately contact our attorneys for an evaluation of your situation at no charge.

You may be entitled to compensation by filing a suit against the pharmaceutical company and our defective drug lawyers can help.

Table Of Contents

What to Know About Prilosec (omeprazole) Lawsuits

An increasing number of proton pump inhibitor lawsuits are being filed against the drug makers. The lawsuits allege that the manufacturer of omeprazole and other PPIs has failed to provide important safety information regarding serious complications such as chronic kidney disease and kidney failure.

Prilosec Uses: Conditions Treated by Prilosec

Prilosec (omeprazole) is a commonly prescribed medication for managing gastroesophageal reflux disease (GERD) and heartburn. Approved by the FDA in June 2003. it reduces stomach acid production by blocking an enzyme in the stomach lining, helping to prevent esophageal irritation.

However, recent research has highlighted potential long-term safety concerns, particularly related to kidney health.

Prilosec (Omeprazole) Dangers and Side Effects

Understanding the symptoms of kidney and cardiovascular conditions is essential for early detection and management.

These conditions can present a wide range of symptoms, from mild to severe, that may disrupt daily life and require prompt medical attention.

The Link Between PPIs and Kidney Health: Key Scientific Insights

Extensive research has shed light on the potential risks associated with prolonged use of proton pump inhibitors (PPIs), including Prilosec.

Recent studies have revealed a significant connection between proton pump inhibitors (PPIs), such as Prilosec, and an increased risk of chronic kidney disease (CKD). Here’s what the research shows and its implications for patients and healthcare providers.

Artistic Rendition of Kidney and Renal Failure

Alarming Increase in CKD Risk

The JAMA Internal Medicine Study analyzed data from over 10,000 adults in the ARIC study and identified a 20%–50% increased risk of chronic kidney disease (CKD) associated with prolonged PPI use [1].

This correlation remained significant even after adjusting for factors such as demographics, socioeconomic status, pre-existing conditions, and the use of other medications [2].

Similarly, findings from the CMAJ Open Study revealed that PPI users had a 2.5-fold increased risk of developing CKD and were 3 times more likely to experience interstitial nephritis compared to those not using PPIs. These studies underscore the heightened kidney-related risks associated with long-term PPI use [3].

Balancing the Risks and Benefits

While the evidence strongly suggests a link between PPI use and kidney disease, causation has not been definitively proven.

However, the findings emphasize that higher doses and long-term use increase the risk, making careful monitoring essential. Researchers recommend that doctors avoid indiscriminate prescribing of PPIs and monitor patients closely for signs of decreased kidney function.

What Patients Should Do

Given the growing concerns over the safety of PPIs like Prilosec, patients should discuss their treatment options with healthcare providers.

Exploring alternative therapies and limiting long-term PPI use may help reduce potential risks. If adverse effects arise, seeking professional advice is critical to ensuring safe and effective management of GERD and heartburn.

The study doesn’t prove a causative association between proton pump inhibitors (PPIs) and kidney disease; however, “We found there was an increasing risk of kidney disease associated with an increasing dose,” the researchers said. “That suggests that perhaps this observed effect is real.”

Kidney Failure Symptoms

According to the American Kidney Fund, kidney failure is the last stage of chronic kidney disease [4].

When the kidneys fail, it means they have stopped functioning adequately enough for the patient to survive without dialysis or a kidney transplant.

Signs and symptoms of decreased kidney function include:

  • itchy skinItching
  • Muscle cramps
  • Nausea/vomiting
  • Not feeling hungry
  • Swelling in the feet and/or ankles
  • Changes in urinary output
  • Breathlessness
  • Trouble sleeping

Patients who suffered from chronic kidney disease may experience the following symptoms:

  • weight loss and poor appetite
  • swollen ankles, feet, or hands
  • shortness of breath
  • blood or protein in your urine
  • an increased need to urinate, particularly at night
  • insomnia
  • itchy skin
  • muscle cramps
  • high blood pressure (hypertension)
  • nausea
  • erectile dysfunction in men

Treatment of Kidney Disease

Patients with serious kidney diseases will require dialysis or a kidney transplant to treat symptoms.

There is no cure for kidney failure, but many people with the condition live long lives while undergoing dialysis or after having a kidney transplant.

There are many options available to treat kidney disease, including kidney transplants and several types of dialysis.

Your doctor can help you figure out which treatment option is best for you.

Acute Interstitial Nephritis Linked to Prilosec Use

Acute interstitial nephritis, or AIN, is characterized by the infiltration into the interstitium of the kidney tubules by inflammatory cells.

Why this occurs in many patients is unclear, but the mechanism of action typically involves an immune-mediated hypersensitivity reaction.

If left untreated, AIN can progress to acute kidney failure (end-stage renal disease or ESRD) and is a common cause of hospital admissions for the condition [5].

A delay in diagnosis and continued use of Prilosec could lead to chronic kidney problems and more serious health consequences.

Artistic rendition of Interstitial Nephritis

Symptoms of Acute Interstitial Nephritis

An analysis of 13 published reports observed that patients with acute interstitial nephritis associated with omeprazole (the active ingredient in Nexium, another PPI) commonly presented with [6]:

  • Malaise
  • Fever
  • Nausea
  • Lethargy
  • Weight loss

Treatment of Acute Interstitial Nephritis

capsules in a woman's handIf Prilosec is determined to be the cause of your acute interstitial nephritis, the only treatment needed may be to quit taking the drug.

However, you should never quit or switch medications without talking to your doctor first.

Other cases of AIN can be treated with anti-inflammatory medications. Quick treatment often leads to a full recovery.

However, nephritis often causes permanent kidney problems before the condition can be diagnosed.

How Common is AIN?

The actual occurrence of PPI-induced acute interstitial nephritis is unknown, as many if not most cases are never reported due to confounding factors and lack of recognition.

Nexium is the PPI most commonly associated with the condition.

AIN has also been reported less frequently with other proton pump inhibitors such as Prevacid (generic: lansoprazole), but this may simply reflect the volume of use and a class effect is suspected [7].

A 2010 study published in the British Medical Journal (BMJ) found 6 cases of acute interstitial nephritis associated with PPIs from 210 kidney biopsies between 2007 and 2008 [8].

Other Medications Linked to Nephritis

In addition to proton pump inhibitors, other types of drugs linked to interstitial nephritis chronic kidney problems include:

  • Antibiotics
  • Quinolones
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  • Diuretics (particularly those with a sulphonamide moiety, such as furosemide and thiazides)
  • Allopurinol
  • Calcium Channel Blockers
  • Angiotensin-Converting Enzyme Inhibitors (particularly captopril),
  • Carbamazepine
  • H2-antagonists
  • Phenytoin
  • Propylthiouracil
  • Quinine

Health Risks Beyond Kidney Concerns: Diseases Linked to Prilosec Use

Emerging research has revealed that Prilosec (omeprazole) and other proton pump inhibitors (PPIs) may contribute to a variety of health risks beyond kidney-related issues. These findings highlight the need for caution and informed decision-making when using PPIs, especially at high doses or for extended periods.

PPIs Linked to Brain Problems, Study Finds

Proton pump inhibitors like Prilosec OTC may cause loss of brain function and fluid buildup in the abdomen, according to a new study published in Hepatology [9].

The study’s authors determined that 52% of patients took a PPI during clinical trials, and these patients had a 31% 1-year risk for loss of brain function (hepatic encephalopathy or “HE”).

“Our findings suggest that prescription of PPIs to patients with cirrhosis at risk of HE needs an appropriate indication,” said Dr. Gitte Dam at Aarhus University Hospital in Denmark, lead author of the study.

PPIs Linked to Increased Risks of Heart Failure, Stroke, and Death

Proton pump inhibitors (PPIs), commonly used to treat heartburn, have been associated with serious health risks, particularly for patients with coronary artery disease (CAD) and those at risk of stroke.

Heart Failure and Death in CAD Patients

A study published on March 23, 2017, in PLOS ONE revealed that PPI use in patients with CAD could increase the risk of heart attack and death [10].

These medications are often prescribed to prevent gastrointestinal complications in CAD patients undergoing chronic antiplatelet therapy (such as aspirin, Plavix, or Effient). However, researchers found that PPI use in this context may lead to several adverse outcomes, including:

  • Pneumonia
  • Micronutrient Deficiencies
  • Osteoporosis-Related Fractures

These findings raise concerns about the widespread use of PPIs in CAD patients and suggest that the potential risks should be carefully considered.

Increased Risk of Ischemic Stroke

Research presented at the American Heart Association’s Scientific Sessions 2016 also linked PPI use to a higher risk of ischemic stroke.

The study analyzed records from 244,679 Danish patients, with an average age of 57, who underwent endoscopy to investigate gastrointestinal symptoms. Over a follow-up period of nearly six years, 9,489 patients experienced their first ischemic stroke.

Key findings include:

  • Overall Risk: Stroke risk increased by 21% for PPI users compared to non-users.
  • Dosage Matters:
    • At low doses, stroke risk was minimal or absent.
    • At high doses, stroke risk varied significantly:
      • Lansoprazole (Prevacid): 30% increased risk.
      • Pantoprazole (Protonix): 94% increased risk.

Related Article: Prevacid Lawsuit Update

A person holding his chest with a red spot

Gastric Tumors, Bone Fractures, and Anemia

Gastric acid plays a crucial role in maintaining health by protecting the body from harmful bacteria and viruses found in food. Proton pump inhibitors (PPIs), however, can reduce gastric acid production by up to 99%.

Prolonged use of PPIs weakens this defense, making users more susceptible to infections. Without sufficient hydrochloric acid, the risk of developing conditions like Clostridium difficile enteritis, diarrhea, and pneumonia increases.

On January 6, 2017, a study published in the British Journal of Clinical Pharmacology highlighted this concern.

Researchers examined data from 565,000 adults and found that PPI users had higher rates of infections caused by C. difficile and Campylobacter bacteria compared to non-users, underscoring the potential risks associated with long-term PPI use.

Pneumonia, Diarrhea, and Systemic Infections

The secretion of gastric acid plays a major role in our health. However, PPIs decrease it by up to 99%.

If these drugs are taken for a long time, the limited gastric acid makes users vulnerable to infection. This is because hydrochloric acid helps to kill bacteria and viruses in the food we eat.

Without it, Clostridium difficile enteritis, diarrhea, and pneumonia are more likely to occur.

January 6, 2017 – People who use PPIs like Prilosec may be at an increased risk of developing severe gut infections, according to a new study.

The research, published Thursday in the British Journal of Clinical Pharmacology, found that among 565,000 adults, patients who took proton pump inhibitors had higher rates of infection with C. difficile and Campylobacter bacteria compared to those who didn’t use the drugs.

PPIs Linked to Increased Risk of Dementia

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.

Bone Fractures

Prolonged use of Prilosec (omeprazole) and other proton pump inhibitors (PPIs) has been linked to weakened bones and an increased risk of fractures. Below is a detailed breakdown of the findings and regulatory warnings.

Impact on Nutrient Absorption and Bone Health

PPIs reduce stomach acid production, which plays a key role in nutrient absorption. When stomach acid levels are significantly lowered:

  • Calcium Absorption: Reduced stomach acid can make it harder for the body to absorb calcium, leading to weakened bones and an increased risk of fractures.

Research Findings on Fracture Risks

2006 JAMA Study

A December 2006 study published in the Journal of the American Medical Association (JAMA) found:

  • Prolonged and/or high-dose use of Prilosec significantly increased the risk of hip fractures in patients over the age of 50.
Key Risk Factors

The risk of fractures is higher for patients who:

  • Take high doses of PPIs.
  • Use PPIs for periods longer than one year.

FDA Safety Warnings

March 2011 Update

The FDA updated its earlier communication, confirming that prolonged use of high-dose PPIs for more than a year can increase the risk of:

  • Osteoporosis
  • Bone fractures of the hip, wrist, and spine.
May 2010 Warning

The FDA announced that prescription-strength PPI drugs must include warnings about:

  • The risk of bone fractures, especially for long-term and high-dose users.

This decision followed a review of several epidemiological studies that found a strong link between PPI use and bone fracture risks.

Prilosec Side Effects May Include Rhabdomyolysis, Case Report Finds

September 26, 2016 – A case report published last month in Medicine suggests that an intravenous dose of the PPI Nexium (esomeprazole) may have caused a patient to develop rhabdomyolysis, a condition in which skeletal muscle breaks down rapidly [11].

Over time, rhabdomyolysis can lead to kidney damage and renal failure, side effects that have previously been linked to the use of proton pump inhibitors.

If you or a loved one experience any of these symptoms, consult a healthcare professional to explore diagnostic options and initiate appropriate treatment.

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Have you or a loved one suffered from the adverse side effects caused by defective medication?

Has There Been a Prilosec Recall?

Despite the numerous studies and case reports linking heartburn medications like Prilosec to nephritis chronic kidney disease, no recall has been issued related to this condition in the U.S. or any other country.

Additional research and further investigation may be needed to uncover all the facts that may eventually lead to a Prilosec recall.

X-ray of broken bones

Warning: Prilosec Can Interfere With Plavix

medical person holding up two capsules

In November 2009, the FDA warned about a serious interaction between Plavix (clopidogrel) and Prilosec (omeprazole).

The warning stated that Prilosec can significantly reduce how well Plavix works, which could increase the risk of heart-related problems.

This is important because about half of Plavix users also take Prilosec or similar medications to manage common side effects of antiplatelet therapy, such as ulcers and bleeding.

Studies show that this interaction reduces the effectiveness of clopidogrel by about 50%, which may increase the risk of heart attacks and strokes.

Risk Assessment

  • Higher Risk of Stroke: Studies show that patients taking both clopidogrel and omeprazole are more likely to have an ischemic stroke. The stroke rate was 81.67 per 1000 person-years for those using both medications, compared to 57.45 per 1000 person-years for patients taking clopidogrel alone. This means the combination increases the risk of stroke by about 39%.
  • Heart Issues: Some studies found no clear increase in overall heart-related risks when these drugs are used together. However, other research suggests the reduced effectiveness of clopidogrel may lead to a higher chance of heart problems.

Addicts Using Prilosec & Imodium Cocktail to Create Heroin-Like High

Some opiate addicts are combining Prilosec with Imodium (loperamide) to obtain a heroin-like high, according to the American Council on Science and Health (ACSH) [12].

Because the body does not absorb Imodium as readily as it does other opiates, users who take Imodium as directed will not experience a high.

However, addicts have learned to mix Imodium with Prilosec to speed up the drug’s absorption into the bloodstream.

“The Prilosec changes the way our body handles the Imodium,” said Dr. William D. Eggleston, a clinical toxicologist at the Upstate New York Poison Center in Syracuse. “We have pumps along our gastrointestinal tract and they pump the Imodium away. Prilosec blocks those pumps, and that drastically reduces the amount of loperamide, or Imodium, needed to produce a high.”

Prilosec Kidney Damage Lawsuits and Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated all federally filed lawsuits involving kidney injuries caused by proton pump inhibitors (PPIs), such as Prilosec OTC, into a multidistrict litigation (MDL) in the District of New Jersey for pretrial proceedings.

This decision marks a shift from the panel’s earlier stance in February, when it rejected a bid to create an MDL.

The reversal came as the number of lawsuits grew significantly, and key defendants—AstraZeneca and Pfizer—who previously opposed centralization, expressed their support.

The MDL aims to streamline the handling of these cases, which share common allegations that PPI manufacturers failed to adequately warn consumers and healthcare providers about the risks of kidney damage, including chronic kidney disease and acute interstitial nephritis.

By centralizing these lawsuits, the court can efficiently manage pretrial matters while ensuring consistency across the growing number of claims.

Allegations and Defendants

To date, over 15,000 individual lawsuits have been filed against manufacturers of PPI drugs. Plaintiffs claim these medications, including Prilosec OTC, caused serious kidney injuries such as chronic kidney disease and acute interstitial nephritis. Defendants in these lawsuits include:

  • AstraZeneca: Maker of prescription Prilosec products.
  • Procter & Gamble: Manufacturer of over-the-counter Prilosec (Omeprazole).

California Woman Alleges Chronic Kidney Problems from Prilosec

March 27, 2017 – A woman from California who is awaiting a kidney transplant has filed a Prilosec class action lawsuit against AstraZeneca alleging that the company failed to warn that long-term use of Prilosec could damage the kidneys.

Plaintiff Penelope Costamagna allegedly used Prilosec to treat heartburn and gastroesophageal reflux disease (GERD) and subsequently developed acute kidney injury that will require transplantation.

MDL Benefits and Future Outlook

The MDL process consolidates similar lawsuits to improve efficiency in the legal system. Lawyers predict the number of cases against PPI manufacturers will continue to grow due to the widespread use of these drugs for long-term conditions.

Centralizing these lawsuits under MDL ensures consistency in handling the claims and allows affected individuals to collectively pursue justice.

Compensation in Prilosec Lawsuits

attorney for hire

Individuals who have suffered severe health issues or lost a loved one due to Prilosec use may be eligible to file lawsuits to recover damages. Compensation in these cases may include:

  • Medical Expenses: Coverage for past, current, and future treatment and recovery costs.
  • Lost Wages: Compensation for past and future income loss due to illness or injury.
  • Loss of Enjoyment in Life: Damages for diminished quality of life.
  • Pain and Suffering: Compensation for physical and emotional distress.
  • Loss of Earning Capacity: For individuals unable to continue working due to health complications.

For many, pursuing legal action serves as a crucial step in managing the financial burden of long-term treatment and recovery associated with Prilosec-related health issues.

Prilosec Lawsuit Settlement Amounts

In October 2023, AstraZeneca reached a $425 million settlement to resolve around 11,000 lawsuits involving its heartburn medications, Nexium and Prilosec.

The lawsuits alleged that these drugs caused chronic kidney disease and other severe health complications. The settlement encompasses claims in the Multidistrict Litigation (MDL) in the U.S. District Court for New Jersey, as well as cases in Delaware and New Jersey Superior Courts.

Despite the settlement, AstraZeneca denies any wrongdoing and maintains that the claims lack merit.

Types of Prilosec Lawsuits

There are two main types of lawsuits that may be filed against Prilosec manufacturers:

  1. Personal Injury Lawsuits
    Filed by individuals who have experienced severe health issues due to Prilosec, these lawsuits claim that manufacturers failed to adequately warn consumers, healthcare providers, and regulatory agencies about the risks associated with prolonged use of the drug.
  2. Wrongful Death Lawsuits
    Family members of individuals who died from health complications linked to long-term Prilosec use may file wrongful death claims. These lawsuits seek compensation for medical expenses, funeral costs, and the emotional and financial losses resulting from their loved one’s death.

Filing a Prilosec Lawsuit: Key Requirements and Process

Filing a lawsuit related to Prilosec requires understanding state-specific requirements, preparing essential documentation, and navigating the legal process.

Below is a step-by-step guide to help you understand the critical aspects of filing and pursuing a Prilosec-related claim.

Step 1: Understand State-Specific Requirements

Each state has unique rules for filing lawsuits, including time limits and documentation needs. Key factors to consider include:

Statute of Limitations

The statute of limitations determines how long you have to file a lawsuit after experiencing harm. This timeframe varies by state:

  • California: 2 years
  • New York: 3 years
  • Texas: 2 years
  • Florida: 4 years
  • Pennsylvania: 2 years
  • New Jersey: 2 years

Filing Fees

Fees for filing a lawsuit vary depending on the jurisdiction. It’s important to confirm these costs with the court where you plan to file.

Required Documentation

Comprehensive medical and legal documentation is essential. This may include:

  • Medical records linking Prilosec use to your health issues.
  • Documentation of treatment and associated expenses.
  • Proof of lost wages or diminished earning capacity.

Step 2: Expert Testimony Requirements

Expert testimony often plays a crucial role in Prilosec-related lawsuits. Experts are typically medical professionals in fields such as gastroenterology or nephrology and may provide evidence to:

  • Establish the connection between Prilosec use and the health issues you experienced.
  • Show that the pharmaceutical company failed to meet the standard of care.
  • Quantify the damages you incurred, including long-term medical expenses and loss of quality of life.

Step 3: Common Defense Arguments

Be prepared for potential defense strategies by Prilosec manufacturers, which may include:

  • Disputing Causation: Arguing that Prilosec did not cause the alleged health issues.
  • Adequate Warning Claims: Asserting that the risks of using Prilosec were clearly communicated to consumers and healthcare providers.
  • Alternative Factors: Presenting evidence that other factors, such as pre-existing conditions or lifestyle choices, contributed to your health problems.

Step 4: Litigation Process Timeline

The legal process for Prilosec lawsuits generally involves several stages:

  1. Initial Consultation: Meet with a lawyer to evaluate your case and discuss your legal options.
  2. Filing a Complaint: Formally start your lawsuit by filing a complaint in the appropriate court.
  3. Discovery Phase: Both parties gather evidence, including medical records, expert opinions, and witness statements.
  4. Pre-Trial Motions: Attorneys may file motions to resolve certain issues or dismiss claims before trial.
  5. Trial: If no settlement is reached, the case proceeds to trial, where both sides present their arguments to a judge or jury.
  6. Settlement Negotiations: Settlements can occur at any stage, often during or just before the trial.

Step 5: Actions to Take Now

If you’re considering legal action, here’s how to get started:

  • Consult with a Lawyer: Seek legal advice to understand your rights, the strength of your case, and the filing requirements in your state.
  • Gather Medical Records: Collect all relevant health documentation, including records of diagnosis, treatment, and related expenses.
  • Document Symptoms and Impact: Keep a detailed log of symptoms, treatment progress, and how the health issues have affected your daily life.

Taking these steps ensures you’re prepared to pursue a lawsuit effectively and maximize your chances of receiving fair compensation.

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See all related dangerous drug lawsuits our lawyers have covered.

FAQs

Has Prilosec Been Subject to Any FDA Warnings?

Yes, the FDA has issued warnings regarding the potential risks of long-term Prilosec use, including increased risk of kidney disease and bone fractures.

What Evidence Is Needed to Support a Prilosec Lawsuit?

Key evidence includes medical records showing the use of Prilosec, documented side effects, expert medical opinions linking Prilosec to health issues, and any relevant research studies.

Can I File a Lawsuit if I Took Prilosec Over-The-Counter?

es, individuals who took Prilosec over-the-counter and suffered severe side effects can file a lawsuit. Both prescription and over-the-counter users may seek compensation for damages.

Get a Free Prilosec Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Prilosec lawsuits. We are handling individual litigation nationwide and currently accepting new kidney damage cases in all 50 states.

Free Confidential Prilosec Lawyer Evaluation: Again, if you were injured by Prilosec side effects, you should contact our law firm immediately for a free case evaluation. You may be entitled to a settlement by filing an omeprazole lawsuit and a Prilosec lawyer can help.

 

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