What are proton pump inhibitors (PPIs)?
Proton pump inhibitors, or PPIs, were introduced in the late 1980s and are used to treat acid-related disorders of the upper gastrointestinal tract, including peptic ulcers, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and for the prevention of gastrointestinal adverse events caused by non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin. They are also used in combination with antibiotics for eradicating Helicobacter pylori, a bacterium that together with acid causes ulcers of the stomach and duodenum.
PPIs work to prevent ulcers and assist in the healing of ulcers in the esophagus, stomach, or duodenum by reducing the production of acid in the stomach wall.
These drugs are available both over-the-counter and by prescription and are among the most commonly used classes of medications in the United States. According to the National Health and Nutrition Examination Survey, the use of PPIs has increased from 3.4 percent to 7.0 percent among men and from 4.8 percent to 8.5 percent among women from 1999-2000 to 2011-2013. The survey also found that 14.9 million people received 157 million prescriptions for PPIs in 2012.
Proton Pump Inhibitor Side Effects
These seemingly safe heartburn drugs have been linked to serious health risks. Those at greater risk of PPI side effects are people who take high doses of the medication and/or take medicine over a long period of time. Proton pump inhibitor side effects include:
- Clostridium difficile infection of the colon
- Osteoporosis-related fractures of the hip, wrist, or spine
- Low levels of magnesium (hypomagnesemia)
- Heart attacks
- Serious allergic reactions
- Stevens-Johnson Syndrome and toxic epidermal necrolysis
- Reduced liver function
- Reduced kidney function
- PPI-induced acute interstitial nephritis (AIN)
Proton Pump Inhibitors and Kidney Disease
In 2017, a study published in the journal Kidney International found that people who used proton pump inhibitors were more likely to develop chronic kidney disease (CKD) even if they haven’t suffered acute kidney injury (AKI) previously. According to the study, PPI users had a 26% increased risk of CKD than users of another common class of acid-reducing medications known as H2 blockers.
Another study published in JAMA Internal Medicine found that PPI users were also more likely to suffer from CKD than people who did not use PPIs. Researchers also noted that many PPI users were taking the drugs for no clear reason, often remote symptoms of dyspepsia or heartburn that have since resolved. In these patients, PPIs should be stopped to determine if symptomatic treatment is needed.
In a study published in BMC Nephrology in August 2016, researchers concluded that proton pump inhibitors were associated with an increased risk of chronic kidney disease and death. Chronic kidney disease can result when acute interstitial nephritis (AIN) goes undiagnosed.
What is PPI-Induced Acute Interstitial Nephritis?
PPI-Induced acute interstitial nephritis (AIN) is a condition where the spaces between the tubules of the kidney cells become inflamed. The injury appears to be more profound in people older than 60. While individuals who suffer from AIN can recover, most will experience some level of permanent kidney function loss. In rare cases, people with PPI-induced AIN will require a kidney transplant.
AIN can be acute (sudden) or chronic (long-term).
In 2004, a study published in the journal Nephrology, Dialysis, and Transplantation concluded that Prilosec (omeprazole) and Prevacid (lansoprazole) were most commonly associated with interstitial nephritis.
Symptoms of PPI-Induced AIN
The most common symptom of interstitial nephritis is a decrease in the amount a person urinates. In some cases, urine output may increase, and some patients experience no symptoms at all. Other signs of PPI-induced AIN include:
- Blood in the urine
- Water retention
- Elevated blood pressure
Proton Pump Inhibitors and Death
A new study published in the British medical journal The BMJ investigating the death rates among PPI users found that people who used the drug were at an increased risk of dying from cardiovascular disease, chronic kidney disease, and upper gastrointestinal cancer. The study, led by Ziyad Al-Aly, M.D., with Washington State University School of Medicine in St. Louis, focused on 157,000 veterans who were prescribed PPIs for the first time and followed them for 10 years. The longer the PPI use, the greater the risk of death, Al-Aly found. Likewise, a patient’s history of these conditions did not influence the results of the study.
Proton Pump Inhibitors and COVID-19
A study published August 2020 in the American Journal of Gastroenterology found that people who used PPIs were at increased risk of contracting COVID-19. Specifically, individuals who took PPIs twice daily were more likely to test positive for the virus than those using lower doses once a day. Likewise, people who used a class of heartburn drugs known as histamine-2 receptor antagonists, or H2 blockers, were not at increased risk of contracting COVID-19.
More than 15,000 lawsuits have been filed against the manufacturers of PPIs, alleging PPI makers didn’t adequately warn consumers or the medical community about the potential risks the heartburn drugs posed. Prilosec lawsuits claim AstraZeneca was aware of the kidney risks of PPIs for at least a decade before notifying the public.
Thousands of PPI lawsuits have been centralized into multidistrict litigation (MDL) under Judge Claire C. Cecchi in the U.S. District for New Jersey. Plaintiffs in the MDL are suing PPI manufacturers after developing kidney damage, including acute interstitial nephritis and acute renal failure, linked to the use of PPI.
A pool of bellwether cases is currently going through expert discovery, with the first bellwether trial scheduled for Nov. 15, 2021, and additional trials to continue into early 2022.
PPI injuries named in lawsuits:
- Kidney disease
- Kidney injury
- Kidney failure
- Acute interstitial nephritis (AIN)
PPI makers named in the proton pump inhibitor MDL include:
- Takeda Pharmaceutical Co.
- Pfizer Inc., and its subsidiaries yet Pharmaceuticals Inc.
- Wyeth LLC
- Wyeth-Ayerst Laboratories
- Proctor & Gamble Company
- Novartis Consumer Health Inc., and its subsidiaries Novartis Vaccines and Diagnostics Inc.
- Novartis Institute for Biomedical Research Inc.
Other PPI Lawsuits
Drugmakers also face proton pump inhibitor lawsuits for failing to warn consumers about other injuries, including bone fractures, infections, and heart attacks. However, Beasley Allen’s focus remains on PPI-induced kidney damage.
Other heartburn drug lawsuits
On April 2, 2020, all prescription and over-the-counter versions of ranitidine, the active ingredient in the heartburn and acid reflux medicine Zantac and its generics were withdrawn from the market because they were contaminated with a probable human carcinogen called N-Nitrosodimethylamine, or NDMA. Zantac is a H2 blocker. Learn more about Zantac Cancer Lawsuits here.
Beasley Allen lawyers are currently investigating PPI-induced acute interstitial nephritis cases. If you or a loved one suspect you have suffered AIN due to PPI use, please contact us.