Proton Pump Inhibitor (PPI) Injury Attorney in New York

Studies link the use of a popular class of gastric acid medication known as Proton Pump Inhibitors (PPIs) with increased risk of kidney disease, damage and failure. Litigation is pending against the manufacturers of PPIs for failing to disclose these significant risks from the public and federal regulators with thousands of lawsuits already filed in state and federal courts.

WHAT ARE PROTON PUMP INHIBITORS?

Proton pump inhibitors (PPIs) are a type of medicine used to treat conditions such as acid reflux, heartburn, stomach ulcers, gastroesophageal reflux disease (“GERD”), Barrett’s esophagus, Zollinger-Ellison syndrome and other stomach acid related conditions.

PPIs work on parietal cells in the stomach lining that secrete gastric juices containing hydrochloric acid used to accelerate the digestion of proteins. Excess acid secretion can however result in the formation of ulcers in the stomach, leading to heartburn and acid reflux. PPIs work by blocking and reducing the production of stomach acid and thereby prevent acid symptoms.

OVER-PRESCRIPTION AND OVERUSE OF PPIs

Since the introduction of PPIs to the pharmaceuticals market they have become among the most commonly prescribed drugs in the world. It is estimated that tens of millions of prescriptions for PPIs are filled each year in the United States alone.

PPIs are prescribed to patients with chronic stomach acid conditions, such as GERD. However, PPIs are also often prescribed to patients suffering from mild heartburn. PPIs are very effective at reducing acid levels and associated symptoms, and present an easy alternative to acid treatment via personal lifestyle changes, such as eating smaller meals, alternative diets or cutting back on alcohol, which would also reduce heart burn and acid reflux symptoms.

PPIs are popular with patients because they are effective, low in toxicity and come with few acute short-term side effects. However, in light of the studies linking PPI treatment with increased risk of kidney damage and disease, the reliance on PPIs by patients and physicians for safe treatment of heartburn and acid reflux symptoms comes into question.

PPIs LINKED TO KIDNEY DAMAGE AND DISEASE

Researchers have established a credible link between PPI use and kidney damage and disease. PPIs can potentially accumulate deposits within the kidneys and produce lesions referred to as acute interstitial nephritis that can result in chronic deterioration of kidney function. PPIs are further linked to increased risk of acute kidney injury, which is characterized by an abrupt deterioration of kidney function.

As the kidneys lose the ability to function, waste in the blood can build to high levels resulting in numerous, serious complications ranging from nerve damage and heart disease to kidney failure and death. Treatment for kidney damage is aimed at limiting damage and preventing further loss of kidney function, however, once the damage has progressed to a chronic condition it is incurable and can only be managed.

Evidence of a connection between PPIs and acute interstitial nephritis and chronic kidney disease has existed as early as 2007. In a review of clinical and pathological findings, researchers from Yale University School of Medicine determined that not only are PPIs “clearly associated with the development of AIN,” but most PPI patients they studied were “left with some level of chronic kidney disease.”[1]

The National Heart, Lung and Blood Institute also sponsored a study in which 10,482 participants with normal baseline kidney function were followed up with for a median of 13.9 years.  After adjusted analysis, the results revealed that PPI users had a 50% greater risk of developing chronic kidney disease than nonusers, and a 64% increased risk of acute kidney injury among PPI users. These findings were then replicated in a cohort of 248,751 patients from the Geisinger Health System of northeastern and central Pennsylvania. The study participants were followed up with for a median of 6.2 years, which produced results showing a 17% increased risk of chronic kidney disease among PPI users as well as an increased risk of kidney disease among twice-a-day users versus once-a-day users of PPIs.[2]

Using cohorts from the Department of Veterans Affairs national databases, another study assessed 173,321 new PPI users and 20,270 new users of histamine 2 blockers (an alternative to PPI treatment) that were followed up for a period of 5 years. This study showed that PPI users had a 28% increased risk for chronic kidney disease and an over 30% increased risk for estimated glomerular filtration rate decline, doubling of serum creatinine levels and end-stage renal disease.[3]

In a population-based study of 290,592 patients over 65 years old, results showed a 2.5-times increased risk for development of acute kidney injury and 3-times increased risk for acute interstitial nephritis among patients recently beginning PPI therapy.[4]

Furthermore, in Sweden, a retrospective population study showed a 1.26-times greater risk of doubling serum creatinine levels after initiating PPI therapy compared to histamine 2 blockers over the course of a median follow up of 2.7 years – indicating impaired kidney function or kidney disease after only several years.[5]

The associated risk of permanent long-term kidney damage and disease due to PPI usage highlights a reasonable need for screening of at-risk individuals.

PPI LITIGATION

Presently, over 4,700 cases have been filed in federal court alleging PPI-induced kidney injuries resulting from the failure of PPI manufacturers to adequately warn patients and physicians of the significant health risks associated with PPIs.

Allegations have also come forward that through misrepresentations and omissions, PPI manufacturers may have concealed significant risks associated with PPI use.

To date, over-the-counter PPIs lack detailed risk information for acute kidney injury, and both prescription and over-the-counter PPIs lack detailed risk information for chronic kidney disease.

PPI-ASSOCIATED INJURIES

PPI usage has been associated with an increased risk in suffering from the following conditions:

• Acute Interstitial Nephritis (“AIN”) – swelling in-between the kidney tubules resulting in a number of symptoms including decreased urine output, fever, fatigue, nausea, vomiting, bloating and abrupt deterioration in kidney function;
• Chronic Kidney Disease (“CKD”) – gradual loss and/or impairment of kidney function;
• Acute Kidney Injury (“AKI”) – sudden episode of kidney failure and/or damage resulting in the  buildup of waste in  blood and disrupting the balance of fluids in the body;
• End Stage Renal Disease (“ESRD”) – occurs when chronic kidney disease reaches an advanced state and the kidneys can no longer function. This condition is life threatening, and must be treated with either dialysis, kidney transplant or conservative care to preserve quality of life; and
• Kidney Failure – resulting in dialysis, kidney transplant surgery and/or death.

PPIs AVAILABLE ON THE MARKET

You may be treating or have treated with one of the following PPI medications for heart burn, acid reflux or GERD symptoms:

• NEXIUM (esomeprazole)
• PRILOSEC (omeprazole)
• PREVACID (lansoprazole)
• PROTONIX (pantoprazole)
• DEXILANT (dexlansoprazole)
• ZEGERID (omeprazole)
• ACIPHEX (rabeprazole)
• VIMOVO (esomeprazole and naproxen)

CONSULT AN ATTORNEY

If you have undergone regular treatment for heartburn, acid reflux or GERD symptoms with any of the aforementioned PPI medications and have experienced kidney damage, disease or failure, contact SPBMC to understand your options for filing suit and protecting your rights.

[1] Brewster, UC and MA Perazella. Acute Kidney Injury Following Proton Pump Inhibitor Therapy, KIDNEY INTERNATIONAL (2007) 71, 589–593.
[2] Lazarus, B., et al. Proton pump inhibitor use and the risk of chronic kidney disease, JAMA INTERN. MED. 2016; 176(2): 238-246.
[3] Xie, Y., et al. Proton pump inhibitors and risk of incident CKD and progression to ESRD, J. AM. SOC. NEPHROL. 2016; 27(10): 3153-3163.
[4] Antoniou, T., et al. Proton pump inhibitors and the risk of acute kidney injury in older patients: a population-based cohort study. CMAJ OPEN. 2015; 3(2): E166-E171.
[5] Klatte DCF, et al. Association between proton pump inhibitor use and risk of progression of chronic kidney disease. GASTROENTEROLOGY. 2017; 153(3): 702-710.