Proton pump inhibitors (PPI’s) have an excellent safety profile and have become one of the most commonly prescribed class of drugs in primary and specialty care. Long-term, sometimes lifetime, use is becoming increasingly common, often without appropriate indications. This article is a short review of the current evidence on this important topic, focusing on the potential adverse effects of long-term proton pump inhibitor use that have generated the greatest concern. Some of the side effects are indicated below.
They are: B12 deficiency; iron deficiency; hypomagnesemia; increased susceptibility to pneumonia, enteric infections, and fractures; hypergastrinemia and cancer; drug interactions; and birth defects.
The benefits of proton pump inhibitor use outweigh its risks in most patients. Elderly, malnourished, immune-compromised, chronically ill, and osteoporotic patients theoretically could be at increased risk from long-term therapy. Digestive Diseases and Sciences April 2011, Volume 56, Issue 4, pp 931–950
The average person may see the term Protein Pump Inhibitors (PPI’s) and think it is something from outer space, or that it is physics related. In layman’s terms it is quite simple. They reduce stomach acids.
Proton-pump inhibitors are a group of drugs whose main action is a pronounced and long-lasting reduction of stomach acid production. Within the class of medications, there is no clear evidence that one agent works better than another. (Google Scholar)
The Layman (Joe Q. Public) may not know what a PPI is, but with some degree of certainty the names will ring a bell. Some examples of proton pump inhibitors approved in the U.S. as provided by Medline Plus:
- aspirin and omeprazole (Yosprala)
- dexlansoprazole (Dexilent, Dexilent Solutab)
- esomeprazole (Nexium, Nexium IV, Nexium 24 HR)
- esomeprazole magnesium/naproxen (Vimovo)
- lansoprazole (Prevacid, Prevacid IV, Prevacid 24-Hour)
- omeprazole (Prilosec, Prilosec OTC)
- omeprazole and sodium bicarbonate (Zegerid, Zegerid OTC)
- pantoprazole (Protonix)
- rabeprazole (Aciphex, Aciphex Sprinkle)
The most common side effects of proton pump inhibitors are:
Serious risks of PPI use may include:
- Bone fracture
- Acute kidney injury
- Chronic kidney disease
- Acute interstitial nephritis
- Low magnesium levels
- Heart attack
- Stroke
- Dementia
As a registered nurse of 28 years I took care of patients with the above serious illnesses. And never for a moment did I associate these illnesses with the usage of PPI’s. As a trained professional I knew of the general side effects. It must make you wonder what Joe Q. Public knows?
Legal Actions Are Being Taken Against Proton Pump Inhibitors
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 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.
Wow. I went into nursing for various reasons. One of them was that I was poor at mathematics. The risk of end stage renal disease is 96% higher in those who took PPI’s! As a patient there are 2 options when it comes to end stage renal disease (ESRD). Death or living your life surrounded by a renal dialysis machine. In my experience many people would prefer death.
PPIs and Bone Fractures
In May 2010, the U.S. Food & Drug Administration (FDA) announced it was revising the safety labeling for PPIs to warn that they might be associated with a higher risk of hip, wrist and spine factures. The new safety information was based on the FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use.
What Specific Legal Action Has Been Taken Against Proton Pump Inhibitors?
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.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
