Proton Pump Inhibitors (PPIs)

Proton pump inhibitors (PPIs) are common medications best known by their brand names, including Nexium, Prevacid and Prilosec. They decrease acid secretion in your stomach and relieve conditions like gastroesophageal reflux disease (GERD), indigestion, ulcers and more.

Research indicates a potential link between the use of PPIs and medical issues, including kidney disease and cognitive decline.

Many people who developed these conditions after using PPIs filed lawsuits claiming that manufacturers failed to warn them about possible side effects. Some cases were settled, while others are pending. If you’ve been injured by PPI use, you can still file a claim.

Proton pump inhibitors (PPIs) are drugs that lower acid production in your stomach. This acid helps you digest food and kills dangerous germs. However, if your body produces too much acid or it ends up in the wrong place, you may experience issues like acid reflux or ulcers.

Some PPIs are available over the counter or with a prescription, including:

• Esomeprazole (Nexium)
• Lansoprazole (Prevacid)
• Omeprazole (Prilosec)
• Omeprazole/sodium bicarbonate (Zegerid)

Other PPIs require a prescription, including:

• Dexlansoprazole (Dexilant)
• Pantoprazole (Protonix)
• Rabeprazole (AcipHex)

Over-the-counter PPIs are generally used for short durations at lower doses. Prescription PPIs are used for more severe conditions and taken at higher doses for longer treatment periods.

How Do PPIs Work?

PPIs block an enzyme that makes stomach acid, the hydrogen-potassium ATPase pump. It’s also known as your “proton pump.” PPIs keep your body’s proton pump from completing the chemical reactions that produce stomach acid.

These medications don’t completely stop your body from creating acid, but they reduce production. According to the Cleveland Clinic, PPIs cause a roughly 65% reduction in stomach acid, leaving you with 35% to help you digest food.

PPIs are an alternative to other medications that reduce stomach acid, like H2 blockers and antacids. H2 blockers create a histamine receptor blockade to lower stomach acid production. Antacids block pepsin, a proteolytic enzyme that aids in digestion, and neutralize acid using ingredients like aluminum, calcium and magnesium.

What Conditions Do PPIs Treat?

PPIs can help treat gastroesophageal reflux disease, ulcers, H. pylori infections and Zollinger-Ellison syndrome.

It can take around 24 hours for PPIs to work effectively. Consider consulting with your health care provider before taking these medications to determine the proper dosage and how long you should take them.

As with any medication, PPIs can cause side effects. Some are common, like dizziness and headaches, while others can be more serious, like kidney damage and dementia.

While these side effects are usually not life-threatening, it can be a good idea to alert your doctor if you experience any of these symptoms.

Serious Health Risks Linked to Long-Term PPI Use

There are also serious health risks associated with long-term PPI use. These include:

These complications are serious and sometimes fatal. Affected PPI users have the right to hold drug makers accountable for failing to provide adequate warnings about these risks.

Research has revealed problems with PPIs for decades, including studies indicating a link between PPI use and medical issues like kidney disease and cognitive decline.

Studies on PPIs & Kidney Disease

Research has linked PPI use to chronic kidney disease, including a study published in JAMA Internal Medicine. This study of more than 10,000 patients revealed that PPI use was associated with a 20% to 50% higher risk of chronic kidney disease.

Additional studies have confirmed a potential link, including a 2023 study published in Cureus where researchers concluded, “Through a comprehensive analysis of existing research, it has become evident that the use of PPIs is associated with certain risks to kidney health.”

Research on PPIs & Dementia Risk

Research has also demonstrated a link between PPIs and an increased risk of dementia, including a 2016 study in JAMA Neurology. This study included more than 73,000 participants 75 or older and found a 44% higher risk of developing Alzheimer’s or a related condition.

More recent studies, including research published in Neurology Journals, confirmed this link. Researchers included 5,712 patients with a mean age of 75.4 and found a 33% increased risk of developing dementia among those who used PPIs for more than 4.4 years.

Other Notable PPI Safety Studies

A 2018 study published in Therapeutic Advances in Drug Safety revealed that PPI use was associated with an increased risk of dying from any cause. However, the study did not offer a clear explanation as to why this was the case.

Researchers from a study published in the Journal of Infection found a potentially increased risk of Clostridioides difficile infection based on how long someone uses PPI and their dosage.

According to a study in Mayo Clinical Proceedings, PPI users might be at twice the risk of developing heart failure or cardiovascular disease. Additionally, a study in Springer Nature found an asthma risk in children linked to PPI use by mothers while their baby was in utero.

The FDA has issued PPI warnings, including alerts about the dangers of decreased magnesium levels from long-term use and a higher risk of hip, wrist and spine fractures. A warning was also issued about the increased risk of gastrointestinal infections that can cause diarrhea.

Some PPI manufacturers have added alerts to their product’s packaging that match warnings from the FDA. For example, Nexium’s label lists some of the information included in the FDA advisories.

The FDA guidelines on PPI use are more relaxed than in many other countries. For example, in the United Kingdom, the National Institute for Clinical Excellence suggests more selective use of PPIs. It also advises reviewing their use at least annually when used long term.

Have Any PPIs Been Recalled?

Glenmark Pharmaceuticals Inc. USA recalled 30 and 100-count bottles of esomeprazole magnesium delayed-release capsules in 2023. An FDA Enforcement Report showed elevated results for organic impurities that exceeded allowable amounts.

Pfizer recalled more than 500,000 vials of their PPI Protonix because it may have been subpotent. The FDA eventually identified it as a class III recall.

Dr. Reddy’s Laboratory recalled two of their Lansoprazole products due to the drug’s therapeutic concentration potentially varying throughout the day.

Additionally, due to incorrect National Drug Code numbers, Zydus Pharmaceuticals recalled their Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg drug in 2024.

Thousands of lawsuits have been filed against PPI manufacturers. Many of these cases rely on studies that link proton pump inhibitors to serious medical conditions. In 2019, lawsuits against PPI manufacturers related to kidney issues were combined into one multidistrict litigation (MDL) in New Jersey.

MDLs may occur when lawsuits with similar allegations are filed against the same defendants. These cases go through most of the legal process together and are presented to one judge.

Plaintiffs in the PPI MDL allege that their use of proton pump inhibitors caused medical issues, including acute interstitial nephritis, chronic kidney disease and other types of kidney damage. They claim manufacturers failed to provide adequate warnings about the dangers of the drugs.

Lawsuits are ongoing, but some defendants have settled. AstraZeneca agreed to pay $425 million to resolve product liability litigations related to Nexium and Prilosec. Additional settlements were reached with GlaxoSmithKline, Procter & Gamble, Pfizer and Takeda Pharmaceuticals.

Lawsuits were also filed related to bone damage resulting from Nexium, which were consolidated into an MDL. While Takeda Pharmaceutical Company settled several claims for an undisclosed sum, a judicial ruling that the plaintiffs couldn’t prove causation ended the bone density MDL in January 2017.

There are 11,808 active PPI lawsuits still pending in the MDL. More plaintiffs may pursue claims seeking compensation for their losses.

Who Is Eligible to File a PPI Lawsuit?

Since the current MDL focuses on kidney damage claims, patients who used PPIs and sustained issues related to their kidneys might be eligible to file a proton pump inhibitor lawsuit.

You can consult an experienced attorney to determine if you can join the MDL or pursue a claim. Drugwatch can connect you to a lawyer for a free consultation.