Proton Pump Inhibitor (PPI) Lawyer

Proton Pump Inhibitors, or PPIs, are a specific type of medication used to relieve symptoms of acid reflux, heartburn, and gastroesophageal reflux disease (GERD). They work by reducing the amount of stomach acid produced by the glands in the stomach. The first PPI, omeprazole, was released in the United States in 1990 and sold under the brand name Prilosec. Along with it’s European counterpart Losec, omeprazole quickly became one of the world’s best-selling drugs.

After 13 years on the market as a prescription medication, the FDA approved an over-the-counter version of Prilosec in 2003. With the advent of additional OTC proton pump inhibitors, these drugs have consistently ranked in the top grossing medications in the country for years. In fact, approximately 15 million Americans use and/or are prescribed PPIs, making it the most commonly prescribed type of drug in the United States.

Proton pump inhibitors are prescribed to treat conditions such as:

Gastroesophageal Reflux DiseaseAcid Peptic Disease
DyspepsiaZollinger-Ellison Syndrome
Peptic or Stomach UlcersAcid Reflux

Our proton-pump inhibitor (PPI) lawyers can answer your questions and help guide you through the legal process of filing a claim against the manufacturers of this drug.

What Causes Gastroesophageal Reflux Disease (GERD)?

The development of acid reflux in a healthy individual should not be seen as an indication of a greater health risk as the condition can develop in otherwise healthy individuals ranging from infants to adults. The condition can be triggered in many ways but typically only occurs in brief spurts without the development of any debilitating or bothersome symptoms.

One of the common causes of GERD is a stomach abnormality called hiatal hernia, which can develop within a wide range of healthy individuals.

The most common cause of acid reflux disease is a problem developing with the lower esophageal sphincter (LES) muscle. The LES muscle acts as an impregnable barrier between the stomach and esophagus and prevents stomach acid from seeping into the esophagus. The muscle loosens and opens as food passes through the esophagus but tightly closes, creating the barrier, once food has reached the stomach.

If something is preventing the LES muscle from closing as it designed to do, stomach acid and other substances will flow into the esophagus causing pain and discomfort.

In addition to pain and discomfort, sufferers report pain in the upper abdomen and chest, nausea, and indigestion among other symptoms. Most reports of GERD do not involve severe pain but in the cases that they do, time after meals is typically the peak of symptom activity.

What Causes Heartburn?

When humans eat, the body increases the production of stomach acid in order to fuel the digestive system. Some foods and beverages can cause more severe heartburn than others. Foods like meats, fruits, vegetables, and foods containing dairy have an effect on the ability for the esophagus to keep acid down. Beverages such as coffee, tea, and alcoholic drinks can also be troublesome. Although, food and beverage triggers can vary from person to person.

Eating large portions can also increase acid indigestion. The more full the stomach becomes, the more pressure is applied to the LES, which is the sphincter at the end of the esophagus that seals acid off from the stomach. This can lead to the LES allowing stomach acid move up through the esophagus, causing heartburn.

Even the worst chronic heartburn can be managed by eating a healthy and proper diet. Acid reflux is also linked to obesity, and symptoms can be minimized by losing weight.

Proton Pump Inhibitors Medications

Ever since omeprazole was approved by the FDA in 1989, several other PPI medications have been introduced to the market. Initially, these medications were prescription only, however, in recent years some of these drugs have been approved for over-the-counter use. The chart below contains information about many of the current PPIs in use today.

DrugBrandFDA ApprovalManufacturer
OmeprazolePrilosec1989AstraZeneca
LansoprazolePrevacid1995Takeda Pharmaceuticals
RabeprazoleAcipHex1999EISAI, Co., Ltd.
PantoprazoleProtonix2000Pfizer
EsomeprazoleNexium2001AstraZeneca
Omeprazole/Sodium BicarbonateZegerid2004Salix Pharmaceuticals
DexlansoprazoleDexilant2009Takeda Pharmaceuticals
Esomeprazole/Naproxen (NSAID)Vimovo2010AstraZeneca

A skilled attorney can help anyone who has been harmed by taking a proton-pump inhibitor file a claim.

Aciphex

One of the major drugs constituting the proton-pump inhibitor class, it was developed to treat symptoms of frequent heartburn caused by acid reflux. It does so by preventing the backup of stomach acid and/or bile into the esophagus which in serious cases can lead to extensive damage.

Aciphex is manufactured by Japanese pharmaceutical company, Eisai Co., Ltd. and was approved by the U.S. Food and Drug Administration in 2002. Since approval, the anti-ulcer drug has become one of the most popular proton-pump inhibitor drugs on the market and is regularly a top 100 yearly selling drug.

The drug – which is in the same pharmacologic class of drug as omeprazole – allows the esophagus to heal from the effects of acid reflux by decreasing the stomach’s ability to make acid. If taken early enough, the drug can prevent the development of ulcers (sores in stomach or esophagus lining) and nonsteroidal anti-inflammatory drug-induced ulcers.

The drug can be prescribed in two forms, a delayed-release tablet or a delayed-released capsule referred to as “Aciphex Sprinkle.” Delayed-release tablets are swallowed whole as a standard pill while Aciphex Sprinkle is administered by sprinkling the opened capsule over food or liquid to be consumed.

In addition to being prescribed to combat symptoms of heartburn and acid reflux, it can be used to treat symptoms similar to Zollinger-Ellison syndrome in which the stomach produces too much acid.

Protonix

The anti-ulcer drug can be administered through two primary methods, delayed-release tablets or delayed-release oral suspension. While tablets are swallowed, the delayed-released oral suspension dosage is administered through disintegration in a consumed portion of apple juice or applesauce.

Developed by Pfizer Inc. subsidiary Wyeth, a New York-based pharmaceutical company, Protonix was initially approved by the U.S. Food and Drug Administration (FDA) in February 2000 for 8-week treatments. Two additional FDA approvals followed the initial approval date with the final approval being announced in April 2002 for long-term treatment to combat health complications, including Zollinger-Ellison Syndrome.

Protonix (pantoprazole) is categorized in the same pharmacoligic class as popular medication Prilosec (omeprazole), sharing a wide range of characteristics with the drug and other PPI medications. The drugs allow the esophagus to heal from exposure to stomach acid by decreasing the amount of acid the stomach produces. With stomach acid withdrawing from the esophagus, ulcers (sores in the lining of the stomach or intestine) and non-steroidal anti-inflammatory drug-induced ulcers can be prevented.

Zegerid

Zegerid is one of the major drugs that constitute the proton pump inhibitor (PPI) drug class designed to combat the symptoms of frequent heartburn caused by the flow of stomach acid into the esophagus – acid reflux.

The drug is available to consumers as a standard capsule and a powder for oral suspension, each taken by mouth. The chemical makeup of both methods works by decreasing the amount of acid the stomach is able to produce, giving the esophagus time to heal from previous acid damage. This healing time allows the body to prevent or halt the development of ulcers – sores in the lining of the stomach or intestine.

Developed by pharmaceutical giant Bayer AG, Zegerid was first approved by the U.S. Food and Drug Administration in 2004 for both methods of use. While being approved primarily to combat the symptoms of acid reflux, the drug is also approved for use for conditions in which the stomach produces too much acid – Zollinger-Ellison syndrome.

What are the Side Effects of Proton Pump Inhibitors?

Like most medications, PPIs have a range of normal side effects that can affect the user. It is also important to note that stomach acid is responsible for fighting dangerous bacteria in the stomach. Because PPIs reduce the production of this acid, the user can become more susceptible to bacterial infections. However, these occurrences are rare. Below are some common side effects associated with most proton pump inhibitors.

HeadacheNausea
DiarrheaAbdominal Pain
FatigueDizziness
RashConstipation

Unfortunately, there has been concern over additional dangerous side effects that may be associated with the use of proton pump inhibitors and can be the basis of a lawsuit with the help of the right lawyer. Research conducted over the last decade has brought about concern regarding PPIs and the effect they have on the heart, kidneys and mental health. Below are some of the most serious complications believed to be associated with proton pump inhibitors.

Heart AttackDementia
Kidney InjuryBone Fractures

Dementia

Dementia is a category of degenerative brain diseases with a wide range of symptoms ranging from memory distortions to serious behavioral and psychological symptoms. There is currently no cure for these conditions. Approximately 36 million people are affected by different types of dementia globally. It is believed as the average lifespan for humans continues to increase, so does the rate of dementia. Nearly half of all people over 85 years and older will suffer from dementia.

A prominent German study published in February 2016 associated PPIs with dementia. The research found that there was a 44 percent increased risk of dementia in users of PPI medication compared to those who were not taking the drug.

Chronic Kidney Disease

The concern over serious complications associated with proton pump inhibitors has been brought on by a series of studies and reports that have been conducted on these drugs. A recent study published in the Journal of the American Society of Nephrology concluded that taking PPIs may dramatically increase the risk of kidney failure and kidney disease. The study looked at data from over 170,000 patients who were currently using PPIs and compared those results to a control group of over 20,000 individuals who were using a proton pump inhibitor alternative. The study determined there was a significant difference in the rates of acute kidney injury and acute interstitial nephritis in patients who took PPIs compared to those who did not — the risk of end-stage renal disease was 96% higher in those who took PPIs.

Other reports have produced similar findings. The Journal of the American Medical Association released findings that proton pump inhibitor users are significantly more likely to suffer from chronic kidney failure. In January 2016, JAMA published a study that found those taking PPIs once daily had a 15% increased risk of chronic kidney disease, and twice daily users were 46% more likely to develop chronic kidney disease. The study also found that those who took PPIs had a 39% higher risk of kidney disease than patients who took H2 blockers, a different type of drug used to treat heartburn and acid reflux. The Canadian Medical Association Journal also released a report in April 2015 that examined over 290,000 PPI users. They found that users of these medications were much more likely to experience acute kidney injury.

Another study on proton pump inhibitors in The Journal of the American Medical Association published in early 2016 suggested an association between PPI medications and CKD. Two groups were studied over a ten-year period consisting of self-reported PPI users. One group contained over 10,000 Americans taking part in a national study on arteriosclerosis, while the other group was part of almost 250,000 patients of a Pennsylvania health care system. Researchers determined that an increased risk of CKD was associated with PPI use in both groups.

In their report, researchers identified a 15% increased risk of chronic kidney disease in PPI users who took the medication once a day. Alarmingly, they also reported a staggering 46% increased risk of the condition in patients who took PPIs more than once per day.

The Journal of the American Medical Association published a study in February 2016 identifying a link between the drug and kidney disease. Over 10,000 participants were studied from a period ranging from 1996 to 2011. According to their findings, the use of proton pump inhibitors was associated with a higher risk of incident chronic kidney disease (CKD).

The following symptoms can be applied to any type of kidney disease including prerenal, intrinsic, and postrenal kidney failure and may vary depending on the severity of the disease.

  • Urine output
  • The gradual diminution of urine can possibly indicate urethral stricture
  • Nausea, vomiting
  • Dehydration
  • Confusion

Oliguria or anuria is the failure to produce a normal amount of urine and is usually accompanied by an AKI, however, polyuria, the opposite of Oli and anuria occurs due to reduced fluid reabsorption by damaged renal tubules.

Acute Kidney Injury (AKI)

Acute renal failure or acute kidney injury occurs when a reduction in blood flow to the kidney causes a loss of kidney function. This is one of the most common types of acute kidney injury, as it can be a complication of almost any disease, condition, or medicine that decreases the normal amount of blood and fluid in the body.

Acute Kidney Injury (AKI) is a condition that results in decreased kidney function or kidney damage within only hours or days. In some cases, acute kidney injury can lead to more serious complications such as chronic kidney disease or complete kidney failure (End-Stage Kidney Disease).

The Canadian Medical Association Journal (CMAJ) published a study in 2015 identifying a link between proton pump inhibitors and acute kidney injury. The nine-year study looked at Canadian residents 66 years of age or older who regularly took PPI drugs like Nexium. About 300,000 people were compared to an equal-sized control group who did not regularly take PPI medication. The study concluded that PPI users were three times as likely to develop ACI complications than the control group.

This same study also measured the rate of interstitial nephritis that occurred in PPI users. Interstitial nephritis is a condition that causes inflammation of the kidneys and can lead to more serious kidney complications such as acute kidney injury. Although the occurrence of interstitial nephritis was much less common in the study, the results still showed a three times higher rate of the condition in users of proton pump inhibitors.

Proton Pump Inhibitor Alternatives

Individuals who suffer from chronic acid reflux do have treatment options other than proton pump inhibitors. Before prescribing PPIs, doctors often recommend a patient try using antacids, a type of medication that neutralizes stomach acid and reduces the amount of acid that is refluxed into the esophagus. However, for patients who suffer from chronic heartburn, also known as gastroesophageal reflux disease (GERD), antacids may not be enough to combat their condition.

Another type of medication commonly used to treat acid indigestion is Histamine H2 receptor antagonists, commonly known as H2 blockers. These medications work to reduce the production of stomach acid, as well as make stomach juices less acidic, so that the esophagus becomes less irritated. Doctors will usually prescribe H2 blockers to patients who suffer from chronic heartburn that is not controlled by antacids. Popular H2 blockers include Pepcid and Zantac.

Should I Hire a Proton Pump Inhibitor Attorney?

Proton pump inhibitors (PPIs) were introduced in the late 1980s for the treatment of acid-related disorders of the upper gastrointestinal tract, including peptic ulcers and gastrointestinal reflux disorders, and are available both as prescription and over-the-counter drugs.

Drug Lawsuit Source is currently investigating PPI-induced Acute Interstitial Nephritis (AIN), which is a condition where the spaces between the tubules of the kidney cells become inflamed. The injury appears to be more profound in individuals older than 60.

While individuals who suffer from AIN can recover, most will suffer from some level of permanent kidney function loss. In rare cases, individuals suffering from PPI-induced AIN will require a kidney transplant.

In the last few years, multiple lawsuits against PPI manufacturers have been settled for large amounts. In 2013, Nexium manufacturer AstraZeneca settled a lawsuit that alleged deceptive marketing tactics were used in promoting the product. The class-action lawsuit settled for $20 million.

Then, in February 2015, AstraZeneca settled another lawsuit for $7.9 million against the United States Government alleging that the company engaged in a kickback scheme that was in violation of the False Claims Act.

Another PPI manufacturer, Teva Pharmaceuticals, settled a class-action lawsuit for $24 million in June 2015. This lawsuit alleged that Teva intentionally withheld a generic version of Nexium off the market after it was found that they were paid off by AstraZeneca.

Studies and reports on PPI complications coupled with the recent history of lawsuits against these companies have prompted attorneys to investigate cases for patients who have been harmed by these drugs. If you believe a PPI medication is responsible for complications you or your loved one has suffered, you may be eligible to file a lawsuit and recover compensation.

Our dangerous drug lawyers can help if you or someone you care for has suffered from the development of any conditions including heart attacks, dementia, kidney injury, or bone fractures caused by PPI. Our top-rated lawyers are handling individual litigation nationwide and currently accepting new Proton Pump Inhibitor cases in all 50 states.

Below is the criteria required for filing a proton pump inhibitor lawsuit with the help of our proton pump inhibitor lawyers:

  • The patient took one of the following PPIs by prescription or over-the-counter for at least one year:
    • Nexium
    • Prilosec
    • Dexilant
    • Prevacid
    • Protonix
    • Aciphex
    • Zegerid
  • A patient diagnosed with new-onset of one of the following while taking the PPI:
    • Acute kidney/renal failure
    • Chronic kidney/renal disease
    • Acute interstitial nephritis
call us

    Sources and References
    1. Prescribing Information – FDA
    2. Aciphex Medication Guide – FDA
    3. Approval Letter – FDA
    4. Aciphex Dosage – Drugs.com
    5. Invokana Type 2 Diabetes Treatment – Invokana.com
    6. Invokana Approval History – Drugs.com
    7. Invokana Safety Annoucement – FDA
    8. DKA (Ketoacidosis) & Ketones – American Diabetes Association
    9. Diabetic Ketoacidosis – Mayo Clinic
    10. Diabetic Ketoacidosis – MedLine Plus
    11. Diabetic Complications and Amputation Prevention – Foot Health Facts
    12. Amputation and Diabetes: How to Protect Your Feet – Mayo Clinic
    13. How to Avoid Amputations if You Have Diabetes – Health.com
    14. Myocardial Infarction – Medscape
    15. Invokana Lawsuit Raises Concern Over Heart Attack Side Effect Risk – News Channel 10
    16. FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood – FDA
    17. Acute Kidney Failure – Mayo Clinic
    18. Invokana Side Effects Center – rxlist.com
    19. Important Safety Information – Invokana.com
    20. Invokana (canagliflozin) tablets – FDA
    21. Drug Safety Communication – FDA
    22. Teva Gets Nod For $24M Nexium Pay-For-Delay Settlement
    23. Proton Pump Inhibitors and the Risk of Acute Kidney Injury in Older Patients: A Population-based Cohort Study
    24. Proton Pump Inhibitors: MedlinePlus Medical Excyclopedia
    25. Proton Pump Inhibitors – Harvard Health
    26. Association of Proton Pump Inhibitors With Risk of Dementia: A Pharmacoepidemiological Claims Data Analysis – PubMed – NCBI
    27. Study Shows Association Between Proton Pump Inhibitors, Chronic Kidney Disease – Nephrology News & Issues
    28. Pfizer Settlement – Fox 43 
    29. Heartburn Drugs Linked To Kidney Disease – CBS News
    30. Medication Guide – FDA
    31. Approval Letter(s) – FDA
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