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The heartburn medication Nexium (esomeprazole magnesium) has recently been linked to an increased risk for the development of kidney failure, nephritis, bone fractures, stomach cancer, and other serious side effects.
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Proton Pump Inhibitor

What is Nexium?

Manufactured by AstraZeneca, Nexium is a popular heartburn medication that belongs to a class of prescription and over the counter drugs called proton pump inhibitors (PPIs) which are used for the short-term treatment of acid reflux disease, which can cause heartburn.

PPIs work to reduce stomach acid, which can treat heartburn and decrease the occurrence of ulcers. Nexium is also commonly used to reduce ulcers caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Nexium Side Effects

Studies have linked Nexium and other common heartburn drugs to the following serious 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
  • Ischemic Stroke Risk
  • Bone fractures (hip fracture, wrist fracture, spine fracture)
  • Broken bones
  • Low magnesium levels (hypomagnesemia)
  • Stomach cancer
  • Gut infections
  • Clostridium difficile associated diarrhea
  • Community-acquired pneumonia
  • Dementia
  • Erectile dysfunction (ED)
  • Severe allergic reactions

Other, less severe side effects of over the counter versions of the drug esomeprazole may include:

  • Headache
  • Diarrhea
  • Nausea
  • Decreased appetite
  • Constipation
  • Dry mouth
  • Abdominal pain
  • Allergic reactions
  • Chest pain
  • Dark urine
  • Fast heartbeat
  • Fever

Chronic Kidney Disease

PPIs May Increase Risk of Kidney Disease: Study

In February 2016, a study published in JAMA Internal Medicine [1] found that taking Nexium may cause a higher kidney disease risk. The researchers looked at data on more than 10,000 participants in the Atherosclerosis Risk in Communities (ARIC) study [2], and determined that over the counter PPI users had a 45% increased risk of developing CKD compared to patients who did not take the medications.

When the figures were adjusted for demographics, socioeconomic and clinical variables, a 50% risk was detected.

Kidney Disease Symptoms

  • Changes in urination
  • Swelling in the ankles, legs, feet and/or hands
  • Fatigue
  • Skin rash / itching
  • Nausea / vomiting
  • Shortness of breath
  • Feeling cold
  • Metallic taste in mouth / ammonia breath
  • Dizziness / trouble concentrating
  • Leg / flank pain

How Nexium Causes Kidney Damage

Taking Nexium prevents the overproduction of stomach acid by turning off some of the acid producing pumps in the stomach while allowing others to operate normally.

Less creation of acid means no more heartburn or damage to the esophagus, but this same mechanism of action decreases the body’s ability to absorb nutrients such as magnesium, which is vital to ensure the kidneys are functioning properly.

This process takes time, and most patients take Nexium for at least 3 months before symptoms begin to appear. In the meantime, potentially irreversible damage is being done to the kidneys.

Kidney Disease Diagnosis

Prior to diagnosis, doctors of patients with kidney disease will first discuss their personal and family history. Among other things, the doctor might ask questions about whether the patient has been diagnosed with high blood pressure, or if they've taken a medication that might affect kidney function, or whether they have any family members who have kidney disease.

Next, the doctor will perform a physical exam, also checking for signs of problems with the patient's heart or blood vessels, and perform a neurological exam.

For kidney disease diagnosis, certain tests and procedures will be necessary including:

  • Blood tests - Kidney function tests look for the level of waste products, such as creatinine and urea, in the blood.
  • Urine tests - Analyzing a urine sample may reveal abnormalities that point to chronic kidney failure and help identify the cause of chronic kidney disease.
  • Imaging tests - Ultrasound is used to assess the patient's kidney structure and size. Other imaging tests may be used in some cases.
  • Removing a sample of kidney tissue for testing - Kidney biopsy is often done with local anesthesia. The biopsy sample is sent to a lab for testing to help determine what's causing the kidney problem.

Treatment

Kidney disease treatments may include:

  • Blood pressure medications - People with kidney disease may experience worsening blood pressure. Your doctor may recommend medications to lower your blood pressure and to preserve kidney function.
  • Medications to lower cholesterol levels - Your doctor may recommend medications called statins to lower your cholesterol. People with chronic kidney disease often experience high levels of bad cholesterol, which can increase the risk of heart disease.
  • Medications to treat anemia - In certain situations, your doctor may recommend supplements of the hormone erythropoietin which aid in production of more red blood cells, which may relieve fatigue and weakness associated with anemia.
  • Medications to relieve swelling - People with chronic kidney disease may retain fluids. This can lead to swelling in the legs, as well as high blood pressure. Medications called diuretics can help maintain the balance of fluids in your body.
  • Medications to protect your bones - Your doctor may prescribe calcium and vitamin D supplements to prevent weak bones and lower your risk of fracture. You may also take medications known as phosphate binders to lower the amount of phosphate in your blood, and protect your blood vessels from damage by calcium deposits (calcification).
  • A lower protein diet to minimize waste products in your blood - As your body processes protein from foods, it creates waste products that your kidneys must filter from your blood. To reduce the amount of work your kidneys must do, your doctor may recommend eating less protein.

Cardiovascular Diseases

Nexium Heart Attack

A study published in the June 2015 issue of PLOS ONE [3] found an increased risk of heart attack among patients who took over the counter Nexium and other PPIs.

The research included conclusions from 2 separate studies that looked at the medical community records of nearly 3 million patients, and determined that users of PPI stomach acid drugs like Nexium and Prilosec have a 16 to 21% increased risk of heart attack compared to patients who did not take the medications.

Read more: Prilosec Lawsuit

FDA Warning on Nexium Bone Fractures

Due to the strong link between heartburn drugs and various types of bone fractures, the U.S. Food and Drug Administration (FDA) announced in May 2010 that the packaging of Nexium would be required to carry an enhanced warning regarding the risks of these side effects.

The label change for the drugs came after the FDA looked at a number of studies that linked the medications to increased bone fracture risks. The warning on the FDA website states:

“Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).”

FDA Drug Safety Communication: PPIs Linked to Increased Risk for Nephritis

In December 2014, the FDA announced that new warnings [5] would be added to the labeling of PPIs like Nexium and Prilosec regarding an increased risk for acute interstitial nephritis.

"Acute interstitial nephritis has been observed in patients taking PPIs including Nexium and Prilosec,”  FDA said. “Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to idiopathic hypersensitivity reaction. Discontinue Nexium if acute interstitial nephritis develops.”

What is Interstitial Nephritis?

Interstitial nephritis is a kidney disorder that occurs when there is excessive swelling between the kidney tubules. The kidneys filter blood and wastes from the body; kidney tubules reabsorb water and organic compounds, removing substances the body doesn’t need through the urine.

Swelling of these tubules can cause a number of kidney symptoms ranging from mild to severe. Interstitial nephritis can be temporary (acute), or it may be long-lasting (chronic) and get worse over time.

Symptoms

Signs and symptoms of interstitial nephritis may include:

  • Blood in the urine
  • Fever
  • Increased or decreased urine output
  • Mental status changes (drowsiness, confusion, coma)
  • Nausea, vomiting
  • Rash
  • Swelling of the bod (any area)
  • Stomach ulcers
  • Weight gain (from retaining fluid)

Treatment

Treatment for interstitial nephritis depends on what’s causing the problem. If Nexium is determined to be the likely cause, your doctor may recommend switching to a heartburn drug with fewer potential side effects. However, you should never switch or quit taking a medication without talking to your doctor first.

Other things you can do to help treat interstitial nephritis include:

  • Limiting salt and fluid in the diet can improve swelling and reduce blood pressure (hypertension).
  • Limiting protein intake can help control the buildup of wastes in the blood (azotemia) which can lead to symptoms of acute kidney failure.

Corticosteroids or stronger anti-inflammatory drugs can sometimes be helpful in treating the condition.

Nexium Could Double Your Risk of Stomach Cancer, Study Finds

December 1, 2017 - long-term use of proton pump inhibitors like Nexium may double your risk of stomach cancer [6], a new study published in the journal Gut has found. The researchers also determined that using PPIs for more than 3 years increases the stomach cancer risk 8-fold.

Nexium Lawyer

Proton Pump Inhibitor Kidney Injury Suits Consolidated in New Jersey

August 4, 2017 - The U.S. Judicial Panel on Multidistrict Litigation (JPML) on Wednesday ordered that all federal lawsuits involving kidney injuries 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 its 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.

Heartburn Medications Linked to Increased Risk of Death

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 [7].

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.

Louisiana Nexium Lawsuit Survives Motion to Dismiss

April 21, 2017 - A Louisiana woman who allegedly developed kidney failure after taking Nexium will be allowed to pursue defect and warning claims, after the judge overseeing the case turned back a defense bid to have the lawsuit dismissed.

In an Order issued March 22, the judge upheld claims of defect in construction or composition and design defect, ruling that Plaintiff Alice Donald had sufficiently pleaded that Nexium was defective in formulation and that there were other safer heartburn medications available on the market.

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.

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 failure and death in patients with coronary artery disease (CAD), according to a recent study published in PLOS ONE [8].

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.

Heartburn Drugs linked to Stomach Infection

January 6, 2017 - People who take proton pump inhibitor heartburn medications may be at an increased risk of developing stomach infections, according to a new study. The research, published Thursday in the British Journal of Clinical Pharmacology, found that among a cohort of 565,000 adults, patients who took PPIs had higher rates of infection with C. difficile and Campylobacter bacteria than those who did not take the medications.

Nexium Side Effects May Cause Rhabdomyolysis After One Dose, Study Finds

September 26, 2016 - The side effects of Nexium, applied intravenously in a single dose, caused a man to develop a severe muscle problem called rhabdomyolysis, according a case report published in last month's edition of the journal Medicine [9].

Doctors from Gyeongsang National University Hospital in South Korea report that the 45-year old patient suffered signs of muscular breakdown after being given an intravenous dose of Nexium.

Nexium Lawsuit Filed in New York

September 14, 2016 - A man from Illinois who alleges he suffered kidney disease from using Nexium has filed a products liability lawsuit against AstraZeneca in the Eastern District of New York. Plaintiff George Mullen claims the drugmaker failed to adequately warn about the risk of serious kidney damage from Nexium despite having knowledge about these dangers. He is seeking in excess of $10 million in damages.

Proton Pump Inhibitors Linked to Brain Problems, Fluid Buildup

September 1, 2016 - PPIs like Nexium may increase the risk for loss of brain function (hepatic encephalopathy) and fluid buildup in the abdomen (ascites), according to a new study published in the journal Hepatology [10].

The researchers found that 52% of test subjects took a proton pump inhibitor at some point during clinical trials, and these patients had a 31% cumulative 1-year risk for hepatic encephalopathy. The study’s authors warned that doctors should exercise caution when prescribing PPIs to patients with risk factors for cirrhosis.

What is Gastroesophageal Reflux Disease?

Gastroesophageal reflux disease (GERD) is a digestive disorder that affects the ring of muscle between your esophagus and your stomach. This ring is called the lower esophageal sphincter (LES).

The term “gastroesophageal” refers to the stomach and esophagus. Reflux means to flow back or return. Gastroesophageal reflux occurs when what’s in your stomach backs up into your esophagus.

In normal digestion, your LES opens to allow food into your stomach. Then it closes to stop food and acidic stomach juices from flowing back into your esophagus. Gastroesophageal reflux happens when the LES is weak or relaxes when it shouldn’t. This lets the stomach's contents flow up into the esophagus.

Risk Factors for GERD

More than 60 million American adults have heartburn at least once a month, and more than 15 million adults have heartburn every day, including many pregnant women. Recent studies show that gastroesophageal reflux disease in infants and children is more common than doctors thought.

It can cause vomiting that happens over and over again. It can also cause coughing and other breathing problems.

Some doctors believe a hiatal hernia may weaken the LES and raise your chances of gastroesophageal reflux. Hiatal hernia happens when the upper part of your stomach moves up into the chest through a small opening in your diaphragm (diaphragmatic hiatus).

The diaphragm is the muscle separating the abdomen from the chest. Recent studies show that the opening in the diaphragm helps support the lower end of the esophagus.

Many people with a hiatal hernia will not have problems with heartburn or reflux. But having a hiatal hernia may allow stomach contents to reflux more easily into the esophagus.

Coughing, vomiting, straining, or sudden physical exertion can raise pressure in your belly and lead to a hiatal hernia. Many otherwise healthy people ages 50 and over have a small one. Although it’s usually a condition of middle age, hiatal hernias affect people of all ages.

PPI Heartburn Drugs Linked to Cardiovascular Complications

August 19, 2016 - Nexium and other proton pump inhibitors may cause cardiovascular complications in patients with heart disease, according to a recent study published in the International Journal of Cardiology [11].

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.

Tennessee Man Alleges Life-Threatening Injuries from Nexium

July 6, 2016 - A man from Tennessee who allegedly developed side effects of Nexium including acute interstitial nephritis and chronic active interstitial nephritis has filed a lawsuit against AstraZeneca.

Plaintiff Charles Bowers began taking the drug in 2003 and continued through 2008, after which he was diagnosed with both forms of nephritis. As a result of his conditions, Bowers must undergo dialysis treatment and needs a kidney transplant in order to survive, according to the suit.

Nexium Prematurely Ages Blood Vessels, Study Finds

May 12, 2016 - Nexium may cause silent damage to blood vessels which may increase the risk of heart attack and/or stroke, according to a study published in Circulation Research [12].

Researchers associated esomeprazole -- the active ingredient in Nexium -- with the faster aging of blood vessel cells, which may damage these cells' ability to perform their usual tasks, making those who take the antacid more likely to suffer a heart attack or a 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.”

Nexium Linked to Chronic Kidney Disease, Study Finds

April 14, 2016 - Long-term use of proton pump inhibitor (PPI) heartburn drugs tied to an increased risk for chronic kidney disease (CKD) and renal failure, according to a study published today in the Journal of the American Society of Nephrology (JSAN) [13].

Researchers compared PPIs to histamine H2 receptor blockers (Pepcid, Tagamet, Zantac), and identified a 28% increased risk of CKD for proton pump inhibitor users. The study reinforces prior research indicating a link between PPIs and kidney damage.

Has a Class Action Been Filed?

A consumer fraud class action lawsuit was filed against AstraZeneca alleging deceptive marketing practices with Nexium. In the complaint, entitled Commonwealth Care Alliance v. AstraZeneca Pharmaceuticals L.P., Docket No. 05-0269, plaintiffs allege the drugmaker violated a Massachusetts state law by deceptively marketing Nexium as superior to Prilosec (generic: omeprazole).

The lawsuit asked the federal court to order AstraZeneca to pay restitution to purchasers for amounts they allegedly overpaid, to award money damages for medical expenses, or to grant other relief.

See the other dangerous pharmaceuticals lawsuits that we've covered.

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Again, if you were injured by Nexium, 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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