Nexium, Prilosec and Prevacid – over-the-counter proton pump inhibitors that don’t need a prescription – are among the most popular medications in modern history. Americans spend billions each year on PPIs, given their ability to stop heartburn, according to a Harvard University publication that warns of the newly discovered risks associated with them. The National Institutes of Health (NIH) pegs that figure at $10 billion.
From their advent on the market in the 1990s, physicians believed they, and other PPIs were safe. But recent studies are sounding significant alarms over their newly discovered side effects, including kidney failure and heart ailments. The studies conclude that PPIs have been over-prescribed and should only be taken for short periods of time; otherwise they expose patients to serious, life-threatening conditions. Thousands of Americans may be suffering from one of these side effects. Lawsuits are now being filed, charging that drug companies have ignored the risks, putting the public in danger.
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Major media now reporting the health risks
In February 2016, a CNN report covered the new research dispelling the idea that these heartburn medications are entirely safe. The CNN report was based on a study in The Journal of The American Society of Nephrology about data gathered from the U.S. Department of Veterans Affairs. It found that “a large percentage” of the 173,321 veterans who were taking PPIs developed kidney problems – including acute interstitial cystitis, kidney failure and chronic kidney disease - compared to 20,270 veterans “who took the alternative histamine H2 receptors” - Pepcid, Tagamet and Zantac - to treat their acid reflux.
The CNN story included this distressing fact: “People taking PPIs had a 96%increased risk of kidney failure compared to people who took alternatives…”
A February, 2016 report by NPR (National Public Radio) discussed other dangerous side effects associated with PPIs - pneumonia, Clostridium difficile (a potentially fatal intestinal infection), osteoporosis and dementia.
Seven popular PPIs
Omeprazole (Prilosec, Prilosec OTC)
Lansoprazole (Prevacid, Prevacid 24-Hour)
Dexlansoprazole (Dexilent, Kapidex)
Zegarid (a rapid release form of omeprazole
Seven serious PPI side effects
Acute Interstial nephritis
Chronic kidney disease (CKD)
Clostridium difficile infection
Heart attacks/heart palpitations
Stevens Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN)
Low magnesium levels, convulsions
Osteoporosis and fractures of the hip, wrist and spine
Acute interstitial nephritis (AIN)
AIN is a life-threatening condition that seriously damages the kidneys. The body’s two kidneys are responsible for a vital function. Every day, they cleanse waste and extra fluid from 120 to 150 quarts of blood, sending that blood through millions of small filters. The process produces one to two quarts of urine that carries the waste and extra fluid out of the body. AIN is a life threatening condition in which the kidney’s filters become inflamed.
AIN can cause irreversible kidney damage, leading to kidney failure. Proton pump inhibitors are one of the most common causes of AIN. Certain antibiotics and diuretics as well as NSAIDS (nonsteroidal anti-inflammatory agents) can also cause this serious condition. Although AIN can be successfully treated, in some cases the outcome is fatal.
Chronic kidney disease CKD)
Researchers also believe that PPIs can cause chronic kidney disease (CKD). The lack of symptoms with CKD can mask the disease until the kidneys have almost stopped working and symptoms of the condition appear. Stage 3 CKD can be managed, while progression to State 5 (end stage renal failure) can occur.
Proton pump inhibitors can cause CKD. Two studies cited in an article published in January 2016 by Jama Internal Medicine suggest that the unexpected rise in cases of CKD may be attributable to proton pump inhibitors when compared to cases of CKD caused by diabetes and hypertension. The article concludes that PPIs are associated with chronic kidney disease.
According to The National Kidney Foundation, 1 adult in every 3 in the U.S. is at risk of developing kidney disease and 26 million Americans currently have the condition and don’t know it. Once the kidneys fail, patients must undergo dialysis or have a kidney transplant to prevent death.
Clostridium difficile infection (C diff)
Clostridium difficile is a bacterium that can cause life-threatening swelling of the colon. It sickens an estimated 500,000 people in the U. S. every year. The Mayo Clinic reports that C diff is becoming more severe and difficult to treat. The elderly are particularly susceptible, especially if they have been hospitalized or reside in nursing homes where the infection is common. Symptoms range from mild diarrhea that can become severe to an inflamed colon, which can be fatal. C diff is beginning to appear in populations that are not usually at risk – “younger and healthy individuals with no history of antibiotic use or exposure to health care facilities, according to the Mayo Clinic.
In 2012, the U.S. Food and Drug Administration (FDA) began warning the public that C diff is associated with the use of proton pump inhibitors and it began working with PPI manufacturers to provide information about the link between PPIs and the potentially fatal condition.
Two Canadian studies in 2015, cited by The National Center for Biotechnology, The National Library of Medicine and the National Institutes of Health in the U.S., linked Proton pump inhibitors to initial episodes of C diff, urging that it be discontinued or patients will remain “at elevated risk” for a recurrence of the intestinal infection.
A German study “has confirmed” a correlation between dementia and individuals from 75 to 79 years of age who have taken the a PPI for 18 months or more. The study cites an “increased risk” for the condition for elderly patients in that category. The story released by Medscape in February 2016, reports that a larger study building on the conclusions of an earlier study has also linked the two.
The second study, conducted at the German Center for Neurodegenerative Diseases in Bonn, is important according to JAMA Neurology, because there is such widespread use of proton pump inhibitors and their use has been “increasing sharply, especially among the elderly.”
Heart attacks and heart palpitations
New studies have found a connection linking cardiovascular events to the use of proton pump inhibitors even in people without a history of heart disease. In June 2016, in an article entitled, “Research Points to ‘Smoking Gun’ for PPI risks,” WebMD pointed to new evidence linking PPIs to heart attacks.
Researchers at California’s Stanford University and The Methodist Hospital in Houston’s world-renowned Medical Center, think they have figured out why these attacks should be added to the growing list of PPI side effects. They believe their research shows how PPIs cause dementia and kidney disease as well as other side effects. They contend that proton pump inhibitors may turn off more than the acid-producing pumps in the stomach, so they block “the production of acid in every cell in our bodies,” reducing the body’s ability to get rid of the “garbage that builds up as we age.”
Low magnesium levels
In 2011, the U.S. Food and Drug Administration (FDA) officially warned the public that long term use of PPIs (a year or more) causes magnesium deficiencies. Magnesium is a critical nutrient, vital to muscle and nerve function, blood sugar levels and, blood pressure. It is also crucial for bones and DNA.
Blood sugar is the main source of energy used by the body’s cells. Proteins are necessary to build bone, skin and muscles. It is vital to the health of enzymes and antibodies. Nerves carry messages from the brain to other parts of the body. These functions can be disrupted without the proper levels of magnesium, leading to muscle spasms, an irregular hearts beat and convulsions. Unfortunately, magnesium supplements do not always make up for the deficiency and PPI use must be discontinued.
Osteoporosis and fractures
In 2010, the U. S. Food and Drug Administration (FDA) noted a “possible” increase in fractures associated with the use of proton pump inhibitors with long term use. But it did not advocate a warning on packages of over-the-counter (OTC) PPIs meant for short intervals of usage.
In June 2014, the FDA added “new safety language” to warnings about the association of fractures and the use of PPIs, urging the shortest duration and lowest dose “of PPIs appropriate to the condition being treated. It warned that patients “at risk for osteoporosis-related fractures “should be managed according to established treatment guidelines.” It noted an increased risk of fractures of the hip, wrist and spine.
Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
PPIs may also cause these painful, and in some cases fatal, skin conditions. Both cause separation of the top layer of the skin (epidermis) from the dermis, the skin’s deeper, more sensitive layer. Sufferers may spend weeks, or possibly months in the hospital, recovering from painful blisters over much of their bodies. These disorders can be fatal. They also cause blistering of the eyes, lips, mouth and esophagus. In some cases, patients have died.
SJS is less severe. In cases of SJS, there is separation of 10% of the skin’s layers. With TEN, separation of the epidermis from the dermis can involve 30 percent of the body’s surface.
SJS/TEN is a rare, hypersensitive reaction to medications. According to The National Center for Biotechnology, The National Library of Medicine and the National Institutes of Health, based on a 2012 review, doctors “should be aware of the possible hypersensitivity reactions due to PPI and routine/empirical prescription for PPI should only be used when clinically indicated.”
- The Mayo Clinic
- The National Center for Biotechnology
- The National Library of Medicine
- The National Institutes of Health
- The U.S. Food and Drug Administration (FDA)
- JAMA Neurology
- The National Kidney Foundation
- Harvard University
- National Public Radio (NPR)
- The Litigator Awards