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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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Free Confidential Lawsuit Evaluation: If you or a loved one suffered kidney damage or other serious side effects from the prescription drug Prilosec, you should contact our law firm immediately for a free case evaluation. You may be entitled to compensation by filing a suit against the pharmaceutical company and our defective drug lawyers can help.

 

 

Proton Pump Inhibitor

 

What is Prilosec?

Medical professionals prescribe Prilosec (generic: omeprazole) to treat the symptoms of gastroesophageal reflux disease (GERD), otherwise known as heartburn.

The drug works by blocking the enzyme in the stomach wall that produces stomach acid. Prilosec is made by the pharmaceutical company AstraZeneca, and was approved by the U.S. Food and Drug Administration (FDA) in June 2003.

When you eat, millions of tiny pumps in your stomach make acid to help digest the food; heartburn occurs when too much of this acid backs up (“refluxes”) into the esophagus. Prilosec works by turning off many of these pumps to reduce the amount of acid produced, but leaving enough for the digestion process.

Side Effects of Proton Pump Inhibitors

  • Acute interstitial nephritis (inflammation of the kidneys)
  • Acute kidney injury
  • Chronic kidney disease (CKD)
  • Kidney failure (renal failure)
  • Heart attack
  • Bone fractures (hip fracture, wrist fracture, spine fracture)
  • Broken bones
  • Low magnesium levels (hypomagnesemia)

Kidney and Renal Failure

Heartburn Drug Users May Develop Chronic Kidney Disease: Study

A January 2016 study published in JAMA Internal Medicine [1] found a link between the use of proton pump inhibitors (PPIs) like Prilosec and chronic kidney disease. Researchers looked at more than 10,000 adults enrolled in the Atherosclerosis Risk in Communities (ARIC) study [2] conducted from Feb. 1, 1996 thru Dec. 31, 2011.

The study determined that PPI heartburn drugs were linked to a 20% to 50% increased risk of chronic kidney disease. The link was confirmed after adjusting for confounding variables including demographics, socioeconomic status, clinical measurements, prevalent comorbidities and concomitant use of other medications.

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.”

Another study published in April 2015 in the medical journal CMAJ Open [3] found that proton pump inhibitor users had a 2.5-fold increased risk of developing chronic kidney disease, as well as a 3 times higher risk of interstitial nephritis compared to patients who did not take the drugs.

The study’s authors highlighted the importance of doctors understanding the risk of decreased kidney function, indicating that patients should be monitored and indiscriminate proton pump inhibitor use should be discouraged.

Kidney Failure Symptoms

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

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

Treatment

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 transplant and several types of dialysis. Your doctor can help you figure out which treatment option is best for you.

Chronic Kidney Disease Symptoms

Patients who suffered 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

Interstitial Nephritis

Acute Interstitial Nephritis

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 [5] (end-stage renal disease or ESRD) and is a common cause of hospital admissions for the condition. A delay in diagnosis and continued use of Prilosec could lead to chronic kidney problems and more serious health consequences.

Symptoms

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

  • Malaise
  • Fever
  • Nausea
  • Lethargy
  • Weight loss

Treatment

If 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 volume of use and a class effect is suspected [7].

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

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

Has There Been a 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 recall of Prilosec or other proton pump inhibitors.

Omeprazole Lawsuit

Bone Fractures

The reduction of stomach acid can make it harder for the body to absorb some nutrients including calcium, which can lead to weakened bones and bone fractures.

A December 2006 study published in the Journal of the American Medical Association (JAMA) found that prolonged and/or heavy use of Prilosec significantly increases the risk of hip fractures in patients over the age of 50.

The risk of these side effects is greatly increased in patients receiving high doses or in intervals greater than a year at a time. In March 2011, the FDA updated an earlier drug safety communication indicating that it has determined that the use of high doses of PPIs for more than a year can increase the risk of osteoporosis and bone fractures of the hip, wrist and spine.

In May 2010, the FDA announced that warnings would be provided about the risk of bone fracture side effects from prescription strength PPI drugs. The warnings came after FDA drug safety reviewers looked at a number of epidemiological studies into PPI bone fracture risks.

Warning: Prilosec Can Interfere With Plavix

In November 2009, the FDA warned the public and healthcare professionals that individuals taking the anti-clotting drug Plavix should not take Prilosec and Nexium because they may lessen the effects of Plavix.

This may prove problematic since approximately 50% of patients taking Plavix also take Nexium, Prilosec and other similar drugs to prevent stomach bleeding and ulcers, which are common side effects of taking Plavix. A previous study indicated that if you took PPI drugs like Prilosec, it may increase ischemic stroke risk by 50%.

PPI Kidney Injury Suits Centralized in New Jersey

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federally-filed lawsuits involving kidney problems from PPI heartburn drugs will be consolidated in the District of New Jersey for pretrial handling.

The panel's ruling marked an about-face from it's previous opinion on the matter, having in February rejected a bid to create an MDL. The reason for the change was due to the litigation's substantial increase in size since the initial ruling, and because 2 defendants who previously opposed centralization -- AstraZeneca and Pfizer -- are now in support of it, according to JPML.

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) [9]. 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.”

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.

California Woman Alleges Chronic Kidney Problems from Prilosec

March 27, 2017 - A woman from California who is awaiting a kidney transplant has filed a products liability 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.

PPIs Linked to Increased Risk for Heart Failure, Death

March 23, 2017 - Proton pump inhibitor heartburn medicines have been linked to an increased risk for heart attack and death in patients with coronary artery disease (CAD), according to a recent study published in PLOS ONE [10].

The researchers found that PPIs are commonly used to prevent complications in CAD patients treated with chronic antiplatelet therapy (aspirin, Plavix, Effient); however, when used in this capacity, proton pump inhibitors may increase the risk of adverse health consequences including pneumonia, micronutrient deficiencies, and osteoporosis-related fractures.

Prilosec linked to Stomach Infections

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.

Prilosec Kidney Damage Lawsuits May Be Consolidated

October 20, 2016 - Plaintiffs who filed lawsuits over serious kidney injuries from Prilosec OTC and other PPI heartburn drugs have filed a motion seeking consolidation of the complaints into a multidistrict litigation (MDL) in the Middle District of Louisiana.

Should the U.S. Judicial Panel on Multidistrict Litigation (JPML) decide to centralize the complaints, plaintiffs around the nation will be united by their common allegations against PPI manufacturers.

Prilosec Side Effects May Include Rhabdomyolysis, Case Report Finds

September 26, 2016 - A case report published last month in Medicine [11] 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.

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.

PPIs Linked to Brain Problems, Study Finds

September 1, 2016 - 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 [12]. 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 Cardiovascular Complications, Study Finds

August 19, 2016 - Prilosec and other proton pump inhibitors may cause cardiovascular complications in patients with heart disease, according to a new study published in the International Journal of Cardiology [13].

PPI users were 6 times more likely to suffer from anemia and a worsening metabolic profile, the study found. The researchers concluded that prolonged use of proton pump inhibitors was associated with a worsening of red blood count indexes, lower weight and underutilization of cardioprotective medications.

Has a Class Action Been Filed?

To date, more than 15,000 individual lawsuits have been filed against PPI drug manufacturers. Defendants in Prilosec lawsuits include AstraZeneca, who makes prescription Prilosec products, and Proctor and Gamble, the maker of Prilosec OTC.

Many of these lawsuits have been grouped into multidistrict litigation (MDL), a process that makes large numbers of individual lawsuits easier for the courts to manage.

Lawyers involved in these cases estimate that the number of lawsuits filed against PPI drugmakers will continue growing based on the wide use of these drugs for long-term health conditions.

What Compensation Could I Be Awarded?

If you’ve suffered personal injury as a result of taking Prilosec, or lost a loved one to severe health issues linked to Prilosec, filing a lawsuit may help you recover damages for:

  • past and current medical expenses
  • projected treatment and recovery expenses
  • past and future wage loss
  • loss of enjoyment for life
  • pain and suffering costs (mental and physical)
  • loss of earning capacity

Recovering compensation from Prilosec drugmakers is not simply a matter of setting the matter straight. Many people who have developed serious health issues after taking Prilosec require extensive, long-term treatment and care, which can become a significant burden to themselves and those around them.

Seeking compensation might serve as a critical part of the treatment and recovery process for many individuals and their loved ones who have suffered after taking Prilosec.

Understanding Types Of Prilosec Lawsuits

One of the basic details that might be important to understand if you wish to take legal action for Prilosec side effects is the different types of lawsuits that may be filed against the manufacturers:

Personal Injury Lawsuits - Can be filed by any individual who has suffered unlawful harm due to the negligence of a person, company, agency, or institution. Prilosec Personal Injury Lawsuits allege that manufacturers failed to properly warn the government, doctors, and consumers of the serious health risks associated with their use.

Wrongful Death Lawsuits - Family members of individuals who have died due to health issues linked to long-term Prilosec use may be eligible to file a Prilosec wrongful death claim.

Related: Dangerous Drugs Lawsuits

Get a Free Prilosec Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at our 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 Case 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 a lawsuit and we can help.

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