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Proton Pump Inhibitor (PPI) Lawsuits

Proton-pump inhibitors are taken by millions of people across the country to treat conditions related to stomach acid.

Sales of PPIs have made their manufacturers billions of dollars each year.

Although the manufacturers warned of some side-effects, many patients taking PPIs experienced severe side-effects and even health complications as a result.

Manufacturers of PPIs are now facing thousands of lawsuits from people harmed by their products.

Do I have a Case?
Jump to topic
  • What Are the PPI Class Action Lawsuit Settlements?
  • What Are the PPI Medical Liability Lawsuits?
  • Should I Consider Getting a PPI Lawyer?
  • How Do I Find a PPI Attorney?
  • What Is a Proton-Pump Inhibitor?
    • How Does a Proton-Pump Inhibitor Work?
      • What Is the Difference Between a Proton-Pump Inhibitor and an H2-Blocker?
    • What Types of Proton-Pump Inhibitors Are There?
  • What Do PPIs Treat?
    • What Is Heartburn?
      • What Are the Symptoms of Heartburn?
      • What Causes Heartburn?
      • What Are the Risk Factors Associated with Heartburn?
    • What Is Acid Reflux?
    • What Is GERD?
      • What Are the Symptoms of GERD?
      • What Causes GERD?
      • What Are the Risk Factors Associated with GERD?
      • What Are the Complications of GERD?
      • What Is Esophageal Stricture?
      • What Is an Esophageal Ulcer?
      • What Is Barret’s Esophagus?
    • What Are Peptic Ulcers?
      • What Are the Symptoms of Peptic Ulcers?
      • What Causes Peptic Ulcers?
      • What Bacteria Cause Peptic Ulcers?
      • What Pain Relievers Cause Peptic Ulcers?
      • What Other Medications can Cause Peptic Ulcers?
    • What Are the Risk Factors Associated with Peptic Ulcers?
    • What Are the Complications of Peptic Ulcers?
      • How Can a Peptic Ulcer Cause an Infection?
      • What Is an Obstruction?
      • How Does an Ulcer Cause Internal Bleeding?
    • How Can I Prevent a Peptic Ulcer?
    • What Is Esophagitis?
      • What Are the Symptoms of Esophagitis?
      • What Are the Types of Esophagitis?
      • What Are the Risk Factors Associated with Esophagitis?
      • What Are the Complications of Esophagitis?
    • What Is Zollinger-Ellison Syndrome?
      • What Are the Symptoms of Zollinger-Ellison Syndrome?
      • What Causes Zollinger-Ellison Syndrome?
  • What Are the Side-Effects of PPIs?
  • What Are the Dangers of Taking PPIs?
  • How Are AstraZeneca and Takeda Liable?
  • Sources

Proton-pump inhibitors used for heartburn and acid reflux have been linked to serious complications such as kidney disease and bone fractures. Manufacturers of Prevacid, Prilosec, and Nexium are facing more than 4,200 PPI lawsuits for complications caused by the medications.

Proton-pump inhibitors were first introduced in 1989 when the first PPI, omeprazole, was approved as “Losec”. The brand name of omeprazole was later changed to “Prilosec”. The second PPI, Prevacid (lansoprazole) was approved in 1995. Since that time, several more PPI medications have been approved, including Nexium (esomeprazole) which was approved in 2001 as a follow-up to Prilosec after patent expiration. In 2003, Prilosec became available without a prescription.

Prevacid and Nexium followed suit and are now available as over-the-counter (OTC) medications. Popular medications known as Proton-Pump Inhibitors (PPIs) are used to treat gastrointestinal ailments such as frequent heartburn and gastroesophageal reflux disease (GERD). These PPI medications work differently than other antacid drugs used to treat heartburn and related stomach ailments. They work by blocking acid production in cells of the stomach to prevent damage to the esophagus caused by reflux.

Overall, the antacid and heartburn medication market brings about $14 billion to manufacturers each year. PPI medications like Prilosec, Nexium, and Prevacid have each made billions of dollars for their manufacturers AstraZeneca and Takeda.

  • Prilosec (omeprazole) – Approved 1989, peak sales year 2000 $6.3 billion
  • Prevacid (pantoprazole) – Approved 1996, peak sales year 2003 $3.6 billion
  • Nexium (esomeprazole) – Approved 2001, peak sales year 2007 $5.2 billion

When first approved, PPI users were warned of side effects like nausea and vomiting, stomach pain, diarrhea, headache, and dizziness but since their introduction, thousands of patients have experienced severe side effects and complications due to these medications. Many of these PPI users and family members have filed lawsuits against AstraZeneca or Takeda for injuries caused by their medications, Prilosec, Nexium and Prevacid. More than 4,200 of these lawsuits are pending in federal court and more may exist in state and local courts.

What Are the PPI Class Action Lawsuit Settlements?

AstraZeneca settled a class action lawsuit in 2015 regarding both Prilosec and Nexium. The lawsuit claimed that the drug company had introduced Nexium only because the patent for Prilosec had run out. Though the drugs are nearly identical in chemistry, Nexium was promoted as an improvement over Prilosec but was much more expensive. AstraZeneca was accused of creating a deceptive marketing campaign to ensure that their product line was “evergreen” and would continue to provide a massive profit. The class action lawsuit was settled with a $20 million payout to participants.

What Are the PPI Medical Liability Lawsuits?

As of May 2018, more than 4,200 lawsuits are pending in court. Federal cases against PPI manufacturers have been consolidated into a multi-district litigation (MDL) in the U.S. District Court for the District of New Jersey. MDL consolidation allows for the cases to be grouped so that lawyers for both plaintiffs and defendants can concentrate their efforts and address many lawsuits at one time.

MDL consolidation also allows for “bellwether” trials to be conducted on a small number of cases to determine how the remaining trials can be expected to go. In many cases, a high dollar award in a bellwether trial will lead to manufacturer-offered settlements for other group members.

The PPI MDL currently contains 4,248 lawsuits against manufacturers of PPI medications including Prilosec and Nexium (AstraZeneca), Prevacid (Takeda), and Protonix (Pfizer). Other PPI lawsuits may also be pending in state and local courts but no cases have been set for trial yet.

Should I Consider Getting a PPI Lawyer?

People who have experienced kidney damage, bone fracture, or other serious side effects after taking Prilosec, Nexium or Prevacid may be eligible to file a PPI lawsuit. Medical injury lawsuits may provide compensation for:

  • Medical costs
  • Lost wages
  • Pain and suffering
  • Future medical expenses
  • Punitive damages

There are no guarantees that a PPI lawsuit would be appropriate or successful. Each case is unique and must be evaluated separately by a legal expert.

How Do I Find a PPI Attorney?

Seeger Weiss offers a free consultation. We’ll discuss with you your unique situation and determine whether or not you have a case. If you’ve suffered a medical condition as a result of taking a proton-pump inhibitor, we will evaluate your claim.

What Is a Proton-Pump Inhibitor?

A proton-pump inhibitor is a type of medication that reduces the amount of acid in the stomach. This type of medication has a similar function to H2-blockers, such as ranitidine, but the method of action is different. Proton-pump inhibitors are now among the most widely purchased medications in the world. They’re actually more commonly prescribed now than H2-blockers for stomach acid-related problems.

How Does a Proton-Pump Inhibitor Work?

A proton-pump inhibitor reduces the amount of stomach acid that is produced by the cells in the lining of the stomach. The stomach contains certain enzymes in its lining that produce acid. These enzymes are the H+/K+ ATPase enzymes, which are also known as the gastric proton pump. They are located in the parietal cells of the stomach, which are found in the gastric glands within the stomach lining.

The gastric proton pumps are the final stage in the process of creating stomach acid. A proton-pump inhibitor will inhibit these proton pumps in order to prevent them from producing stomach acid.

What Is the Difference Between a Proton-Pump Inhibitor and an H2-Blocker?

Both H2-blockers and PPIs are used to treat health conditions that are caused by an excess of stomach acid, such as GERD or acid reflux. They both treat these conditions by reducing the amount of acid in the stomach. However, PPIs are generally considered to be the stronger of the two medications.

Although there is some overlap in what the two types of medications treat, some conditions, such as peptic ulcers, may be treated with H2-blockers instead of PPIs because H2-blockers specifically target the stomach acid that causes the ulcer. In general, however, PPIs have replaced H2-blockers as the treatment for many stomach acid-related health conditions because of its increased strength.

What Types of Proton-Pump Inhibitors Are There?

In the United States, the following types of proton-pump inhibitors are available:

  • Dexlansoprazole (Dexilant)
  • Esomeprazole (Nexium)
  • Lansoprazole (Prevacid)
  • Omeprazole (Prilosec)
    • Omeprazole immediate-release with sodium bicarbonate (Zegerid)
  • Pantoprazole (Protonix)
  • Rabeprazole (Aciphex)

All proton-pump inhibitors have names ending in “-prazole.” Some types of PPI are available over-the-counter, while others may require a prescription from a doctor.

What Do PPIs Treat?

Proton-pump inhibitors are used to treat health conditions that result from an excess of stomach acid. These health conditions include:

  • Heartburn
  • Acid reflux
  • GERD
  • Peptic ulcers
    • Duodenal
    • Gastric
  • Esophagitis
  • Zollinger-Ellison Syndrome

Typically, heartburn can be treated with an over-the-counter PPI while the more serious health conditions like GERD, ulcers, erosive esophagitis, and Zollinger-Ellison Syndrome may require a prescription version.

What Is Heartburn?

Heartburn is burning chest pain located behind the breastbone. It’s typically worse in the evening, after eating, or when lying down or bending over. Many people get heartburn occasionally and this is no cause for concern. However, some people experience heartburn with such frequency that it interferes with their daily lives, which would indicate that the heartburn is actually a symptom of a more serious condition.

Most heartburn can be treated with over-the-counter medication and/or changes to their lifestyle. If the heartburn is a symptom of something more, then prescription medication may be required to manage both the discomfort of heartburn and the condition causing it.

What Are the Symptoms of Heartburn?

The symptoms of heartburn can include:

  • An acidic or bitter taste in the mouth
  • Burning chest pain that worsens when lying down or bending over
  • Burning chest pain that worsens after eating or in the evening

What Causes Heartburn?

The burning pain of heartburn is caused by stomach acid backing up into the esophagus. At the end of the esophagus where it meets the stomach is the esophageal sphincter. This is a band of muscle around the end of the esophagus that loosens to allow food to pass through but then tightens again when you’ve finished eating. However, if the esophageal sphincter loosens or weakens abnormally, then it can allow stomach acid to creep back up the esophagus.

What Are the Risk Factors Associated with Heartburn?

There are certain factors that can increase the risk of experiencing heartburn. These risk factors include:

  • Weight
  • Pregnancy
  • Spicy foods
  • Tomato products
  • Citrus
  • Fatty foods
  • Fried foods
  • Onions
  • Chocolate
  • Peppermint
  • Alcohol
  • Caffeinated beverages
  • Carbonated beverages
  • Large meals

What Is Acid Reflux?

Acid reflux is essentially the same thing as GERD. Acid reflux occurs when stomach acid backs up into the esophagus from the stomach due to the esophageal sphincter loosening or weakening inappropriately. Acid reflux is what causes the sensation of heartburn. Periodic acid reflux is normal and many people experience it from time to time. It’s when it becomes more frequent or severe that the acid reflux is GERD.

What Is GERD?

GERD, or gastroesophageal reflux disease, is frequently-occurring acid reflux. People with GERD experience acid reflux either mildly at least twice a week or more severely at least once a week. Most people with GERD are able to control the symptoms with some lifestyle changes and by taking over-the-counter medication. Some, however, have more severe symptoms that they need to address with a stronger medication like a PPI or even surgery.

What Are the Symptoms of GERD?

The symptoms of GERD can include:

  • Chest pain
  • Trouble swallowing
  • A feeling of a lump in the throat
  • Regurgitation of sour liquid
  • Regurgitation of food
  • Heartburn
    • Usually after eating
    • Worse at night

Anyone who experiences the acid reflux of GERD at night, there may be additional symptoms, including:

  • Disrupted sleep
  • Laryngitis
  • Chronic cough
  • Asthma
    • New if you’ve never had asthma before
    • Worsening if you already have asthma

What Causes GERD?

Frequent acid reflux causes GERD. Acid reflux occurs when the esophageal sphincter muscle located where the esophagus meets the stomach fails to tighten to after swallowing to prevent stomach acid from washing back up the esophagus. In GERD, this occurs frequently, at least once a week if symptoms are more severe or at least twice a week if symptoms are milder.

The constant presence of stomach acid in the esophagus can irritate the esophageal lining, causing inflammation. The lining of the stomach is designed to withstand the acid present there to break down food. However, the esophagus doesn’t have the same resistance to the acid and can eventually develop erosive esophagitis.

What Are the Risk Factors Associated with GERD?

There are some health conditions that can increase the risk of developing GERD. These risk factors include:

  • Pregnancy
  • Obesity
  • Hiatal hernia
  • A connective tissue disorder
    • Ex. scleroderma
  • A delay in the stomach emptying

If you already have GERD or acid reflux, the following can exacerbate the condition and make the symptoms worse:

  • Smoking
  • Drinking alcoholic or caffeinated beverages
  • Eating a large meal
  • Eating late at night
  • Eating trigger foods:
    • Spicy foods
    • Tomato products
    • Citrus
    • Fatty foods
    • Fried foods
    • Onions
    • Chocolate
    • Peppermint
    • Alcohol
  • Certain medications
    • Ex. aspirin

What Are the Complications of GERD?

Over time, GERD can cause:

  • Esophageal stricture
  • Esophageal ulcers
  • Barrett’s esophagus

What Is Esophageal Stricture?

Esophageal stricture is the narrowing of the esophagus. The acid reflux from GERD can, over time, cause damage to the esophagus. Scar tissue forms, narrowing the esophagus and leaving less room for food to pass through. This can cause difficulty swallowing.

What Is an Esophageal Ulcer?

An ulcer is an open sore within an organ of the body. An esophageal ulcer occurs in the esophagus when acid from the stomach that gets into the esophagus eats away at the esophageal lining. Esophageal ulcers can end up bleeding, which can cause both pain and trouble swallowing.

What Is Barret’s Esophagus?

Barrett’s esophagus is a condition caused when changes are made in the esophageal lining due to damage from stomach acid. These changes to the esophagus are associated with the increased risk of developing esophageal cancer.

What Are Peptic Ulcers?

A peptic ulcer is an open sore that can develop either in the lining of the stomach or in the upper small intestine. There are two types of peptic ulcer:

  • Duodenal
  • Gastric

Gastric ulcers are the ones that form within the stomach, while duodenal ulcers form in the upper small intestine. They’re most commonly caused by bacterial infections, especially H. pylori. They can also be caused by the long-term use of certain medications, including:

  • Aspirin
  • NSAIDs
    • Advil
    • Aleve
    • And others

Many believe that spicy foods and stress can cause ulcers. However, this is not true. Neither can cause an ulcer to form, but both spicy foods and stress can make the symptoms of an already existing ulcer worse.

What Are the Symptoms of Peptic Ulcers?

The most common symptom of a peptic ulcer is stomach pain. On top of that, there are other symptoms indicating the presence of an ulcer, including:

  • A feeling of being full
  • A bloated feeling
  • Belching
  • Nausea
  • Heartburn
  • An intolerance for fatty foods

Many people, up to three-quarters of those who have peptic ulcers, don’t actually experience any symptoms at all. Those who do experience the more common symptoms can generally manage the symptoms by eating foods that can buffer the acid in the stomach or by taking a medication that can reduce stomach acid. With these methods, however, the ulcer could return. In people who do experience stomach pain from the ulcer, the pain may be worse at night or in between eating.

Rarely, a peptic ulcer can cause more severe symptoms, which include:

  • Vomiting
  • Vomiting blood
  • Nausea
  • Bloody stools
  • Tarry or black stools
  • Difficulty breathing
  • Feeling faint
  • Changes in appetite
  • Inexplicable weight loss

Anyone who experiences the more severe symptoms of an ulcer should see a doctor.

What Causes Peptic Ulcers?

Peptic ulcers can be caused by stomach acid in the digestive tract, either the stomach or in the small intestine, eats away at the lining, causing an open sore. Normally, the lining of the digestive tract is covered in a layer of mucus that protects it from the acid in the stomach. However, ulcers can develop when there’s either more stomach acid than the mucus can protect against or if there’s less mucus.

Some common causes of ulcers include:

  • Bacteria
  • Regular pain reliever use
  • Other types of medication

What Bacteria Cause Peptic Ulcers?

The bacterium H. pylori commonly lives in the stomach without causing any problems. However, sometimes the bacteria can cause inflammation in the stomach lining that leads to an ulcer. H. pylori are thought to be transmitted through food and drink or kissing, but it’s not known for certain exactly how it spreads.

What Pain Relievers Cause Peptic Ulcers?

Peptic ulcers can be caused by frequent usage of certain pain medications, including aspirin and NSAIDs, or non-steroidal anti-inflammatory drugs. Ulcers caused by medication are common in older adults who may have to take them more frequently. The medications that can lead to peptic ulcers can include:

  • Ibuprofen
    • Advil
    • Motrin IB
  • Naproxen sodium
    • Aleve
    • Anaprox
  • Ketoprofen

Other medications that aren’t listed but that fall into these categories can also cause ulcers if taken frequently. Acetaminophen, which includes Tylenol, is not included and doesn’t cause ulcers.

What Other Medications can Cause Peptic Ulcers?

Although other types of medications may not necessarily cause peptic ulcers on their own, some can greatly increase the chances of an ulcer if taken alongside an NSAID. These medications can include:

  • Alendronate (Fosamax)
  • Anticoagulants
  • Low-dose aspirin
  • Risedronate (Actonel)
  • Selective serotonin reuptake inhibitors (SSRIs)
  • Steroids

What Are the Risk Factors Associated with Peptic Ulcers?

There are some factors that can increase a person’s risk of developing an ulcer, even if they don’t cause ulcers by themselves. These risk factors can also make the symptoms of a peptic ulcer worse and make the ulcer take longer to heal. The risk factors associated with peptic ulcers can include:

  • Stress
  • Smoking
  • Eating spicy foods
  • Drinking alcohol

Alcohol can both reduce the protective layer of mucus in the stomach and increase the amount of stomach acid produced. For those who have the H. pylori bacteria in their stomachs, smoking can increase the risk of an ulcer.

What Are the Complications of Peptic Ulcers?

If a peptic ulcer is left untreated, there are some health complications that can occur as a result. These potential complications can include:

  • Infection
  • Obstruction
  • Internal bleeding

How Can a Peptic Ulcer Cause an Infection?

A peptic ulcer can eventually eat away at the lining of the stomach or of the small intestine until it causes a perforation, or a hole. This perforation can put someone at serious risk of developing peritonitis, or an infection of the abdominal cavity.

What Is an Obstruction?

An obstruction occurs when the passage of food is blocked. A peptic ulcer can prevent food from passing through the stomach or small intestine, resulting in patients feeling full more quickly, vomiting, or even losing weight. The obstruction is caused either by swelling or by scar tissue from contact with the stomach acid.

How Does an Ulcer Cause Internal Bleeding?

The ulcer can bleed, usually slowly, resulting in anemia and blood loss. This can result in hospitalization or even a blood transfusion. Symptoms of internal bleeding due to an ulcer can include bloody or black vomit or stools.

How Can I Prevent a Peptic Ulcer?

There are some steps that you can take as precautions to prevent the possibility of a peptic ulcer occurring. You can reduce the risk of coming into contact with H. pylori by washing your hands frequently and making sure to thoroughly wash and cook all food. If you regularly take a pain medication, you can also work with your doctor to find the lowest possible dosage that still works to bring pain relief. You can also take the medication with meals to reduce the risk of an ulcer.

What Is Esophagitis?

Esophagitis is the inflammation of or damage to the esophagus. Acid from the stomach washing back up the esophagus can inflame the tissue in the esophagus, eroding it over time or causing scar tissue to form. If esophagitis isn’t treated, it can eventually interfere with your ability to swallow normally, as the esophagus can narrow from the presence of scar tissue.

What Are the Symptoms of Esophagitis?

The symptoms of esophagitis can include:

  • Pain while swallowing
  • Trouble swallowing
  • Food impaction (food gets stuck in the esophagus)
  • Acid regurgitation
  • Heartburn
  • Chest pain (particularly behind the breast bone)

Infants and young children can also experience esophagitis. Symptoms in young children can include:

  • Failure to thrive
  • Difficulty feeding

Many of the symptoms of esophagitis can actually be caused by other digestive issues. It’s important to note how long the symptoms last for. You should see a doctor if symptoms of esophagitis:

  • Last for longer than a few days
  • Interfere with eating
  • Don’t improve after taking an over-the-counter antacid
  • Are accompanied by flu-like symptoms, including:
    • Headache
    • Fever
    • Muscle aches

If you experience any of the following, you should seek emergency care immediately:

  • Chest pain lasting longer than a few minutes
  • Food is lodged in your esophagus
  • Pain in the mouth and throat while eating
  • Shortness of breath after eating
  • Chest pain after eating
  • You have a history of chest pain and heart disease
  • Large amounts of forceful vomiting, especially if the vomit is green, yellow, contains blood, or looks like coffee grounds or you experience shortness of breath after vomiting

What Are the Types of Esophagitis?

There are multiple types of esophagitis, each with a different cause. The symptoms will be similar across all of them, however. The different types of esophagitis include:

  • Reflux esophagitis – this is the type of esophagitis caused by frequent acid reflux
  • Eosinophilic esophagitis – caused by a prevalence of eosinophils white blood cells
  • Lymphocytic esophagitis – caused by increased numbers of lymphocytes in the esophageal lining
  • Drug-induced esophagitis
  • Infectious esophagitis – caused by bacteria or fungi in the esophagus

What Are the Risk Factors Associated with Esophagitis?

There are some factors that can increase the risk of developing esophagitis. These risk factors include:

  • Smoking
  • Being overweight
  • Pregnancy
  • Eating large meals
  • Eating fatty foods
  • Consuming any of the following foods or drinks:
    • Alcohol
    • Caffeinated beverages
    • Chocolate
    • Mint-flavored foods
    • Tomato-based foods
    • Garlic
    • Onion
    • Citrus
    • Spicy foods

What Are the Complications of Esophagitis?

Esophagitis can, if left untreated, change the esophageal structure. These potential complications can include:

  • Scarring in the esophagus
  • Narrowing of the esophagus due to scar tissue
  • Risk of esophageal cancer
  • Tearing of the esophageal lining

What Is Zollinger-Ellison Syndrome?

Zollinger-Ellison syndrome is rare. It’s a condition that causes tumors, called gastrinomas, to form in the pancreas or in the small intestine. These tumors can increase the production of stomach acid, eventually leading to peptic ulcers. Most people who develop Zollinger-Ellison syndrome are diagnosed between the ages of 20 and 50, although it can occur at any time.

What Are the Symptoms of Zollinger-Ellison Syndrome?

The symptoms of Zollinger-Ellison syndrome can include:

  • Diarrhea
  • Abdominal pain
  • Acid reflux
  • Heartburn
  • Discomfort, aching, or a burning or gnawing sensation in the upper abdomen
  • Nausea
  • Vomiting
  • Digestive tract bleeding
  • A decreased appetite
  • Unintentional weight loss

You should see your doctor if you’ve been experiencing pain, vomiting, diarrhea, and nausea, or a burning, aching, or gnawing feeling in your abdomen.

What Causes Zollinger-Ellison Syndrome?

It’s currently unknown exactly what causes Zollinger-Ellison syndrome. However, the exact sequence of the syndrome’s progression is known. It begins with the formation of the gastrinoma tumors in the pancreas or upper small intestine. These tumors are made up of cells that produce gastrin, the hormone that causes the stomach to produce acid. With so much extra gastrin, the stomach ends up producing way too much stomach acid, which can result in ulcers.

What Are the Side-Effects of PPIs?

The most common side-effects of PPIs include:

  • Nausea
  • Vomiting
  • Headache
  • Diarrhea

What Are the Dangers of Taking PPIs?

Millions of people have used PPIs like Prilosec, Nexium and Prevacid to treat heartburn, reflux and other stomach conditions every year. They have been promoted as a safe and more effective alternative to other antacid treatments and have been widely used in both prescription and OTC formulations.

In 2010, the results of two separate studies indicated emerging concerns over potential risks of PPI use, mainly an increased risk of bone fracture in the hip, wrist, or spine. Based on these results, the Food and Drug Administration (FDA) determined that the risk was most prevalent in patients who were placed on higher doses and took them for a long period of time and did not require labeling changes or additional safety warnings.

Since that time, a number of studies have confirmed increased risks of PPI use and concerning a wider range of medical conditions.

Some serious risks of taking PPIs can include:

  • Bone fracture
  • Acute kidney injury
  • Chronic kidney disease
  • Acute interstitial nephritis
  • Low magnesium levels
  • Heart attack
  • Stroke
  • Dementia

A 2016 study published in JAMA’s Internal Medicine showed PPI users may have a 20 to 50% increased risk for chronic kidney damage. Chronic kidney disease indicates decreasing kidney function which can worsen over time and lead to kidney failure, requiring a kidney transplant. Other studies have indicated a 21% increased risk of stroke and heart attack, increased risk of gastric cancer for certain patients, and demonstrated further evidence of bone fracture. Though rare, PPI use may also be linked to a skin condition known as erythroderma, which can be fatal.

Researchers have examined the potential for sudden and early death due to PPI use. When compared to other antacid medications such as H2 inhibitors, the 5-year death rate of PPI users may be as much as 50% higher due to medical complications caused by the drugs. Many of these complications may develop slowly over time and go unnoticed until significant disease progression has occurred.

How Are AstraZeneca and Takeda Liable?

PPI manufacturers AstraZeneca (Prilosec, Nexium) and Takeda (Prevacid) are facing thousands of lawsuits for injuries caused by their medications. PPI lawsuits claim that the drugs were not tested properly and that the companies failed to adequately warn both the medical community and the public of potential risks.

PPIs were initially intended to be used to treat gastric or peptic ulcer disease (PUD) which can be diagnosed with imaging studies or through bacterial cultures. Later approvals expanded use to other disorders such as gastroesophageal reflux disease (GERD) which is diagnosed only by symptoms, with no testing required.

In addition to the official “indications” or approved reasons for use, many doctors prescribed PPIs for a wider range of stomach disorders and for a longer time of use than had been studied. Because of the popularity, Prilosec, Prevacid, and Nexium were all top-10 selling prescription drugs during their peak, raking in $billions each year for AstraZeneca and Takeda.

When prescription sales became threatened by patent expiration or competing medications, both AstraZeneca and Takeda quickly moved to obtain approval to begin marketing their medications over-the-counter. OTC use which does not require a prescription may also eliminate a safety check at the physician’s office and allow vulnerable patients to use medications inappropriately or taking them for longer than safe.

Both companies have been accused of using aggressive marketing tactics on both health professionals and to consumers, of failing to warn of the risks of PPI use, and of placing profits above safety.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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