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Researchers used to think that proton pump inhibitors, drugs used to dampen the stomach’s release of gastric acid, were perfectly safe. But a slew of recent research, along with a trend towards long-term use, have many scientists rethinking the potential dangers of PPIs.
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Proton pump inhibitors are the world’s third most-prescribed class of drugs. Estimates suggest that these heartburn medications, which were once believed to be entirely safe, are used by 1 out of every 20 people in the developed world. But now that millions of people are taking these drugs, and using them for longer periods of time, researchers have raised serious concerns about the side effects of proton pump inhibitors.
To date, proton pump inhibitors have been linked to numerous major side effects, including:
Recent studies have found that people taking PPIs may be at an increased risk for kidney problems, including chronic kidney disease, a potential cause of kidney failure.
With evidence mounting, but few warnings from manufacturers, it’s no surprise that some patients have decided to take legal action. Several patients have filed suit against the makers of Prevacid and Nexium, claiming the companies failed to warn patients about the risk of bone fracture. In 2016, a man filed what many legal observers believe to be the first lawsuit for kidney failure against AstraZeneca, the manufacturer of popular PPI Nexium. Several other patients have filed suit, as well.
Proton pump inhibitors, or PPIs, block the release of stomach acids.
In the past decade, worldwide use of proton pump inhibitors grew by 300%, and today, around 15 million American patients take PPIs, according to NPR. The drugs are sold both by prescription and over-the-counter. Some of the most recognizable brand name drugs, including Nexium, Prilosec and Prevacid, belong to this category of chemicals, along with lesser-known medications like:
In 2009, omeprazole, sold as Prilosec, was the most popular PPI, according to an industry-sponsored FDA analysis made public the following year. Products containing omeprazole captured 42% of the US market for proton pump inhibitors, with a total of 40 million prescriptions in 2009. Esomeprazole, the active ingredient in Nexium, came in second at 26 million prescriptions, or 28% of the total market share, with Prevacid‘s lansoprazole rounding out the top three at 15 million prescriptions. Those numbers, however, were changing. The FDA noted rapid increases in both esomeprazole (Nexium) and omeprazole (Prilosec) prescriptions, while prescription rates for less-recognizable proton pump inhibitors had stagnated or dropped.
PPIs are used to treat a wide variety of gastrointestinal disorders, along with isolated symptoms of gastric conditions, most notably dyspepsia, or indigestion. But more and more patients are taking proton pump inhibitors for chronic conditions, including gastroesophageal reflux disease (GRD), a condition that may affect up to 40% of US adults every month.
This trend to longer and longer exposures has raised alarms with many scientific researchers since PPIs were originally intended only as a short-term treatment option. Of particular concern is the effect long-term PPI use may have on the body’s ability to absorb vital nutrients, like vitamin B12, iron, magnesium, and calcium.
Vitamin and mineral deficiencies are a reported complication of proton pump inhibitors, including infrequent but severe reports of hypomagnesemia, a magnesium deficiency in the blood.
Magnesium plays a fundamental role in numerous cellular processes, and deficiencies in the mineral can lead to alterations in the heart’s electrical activity. Left untreated, hypomagnesemia can cause arrhythmia, or abnormal heart beats, along with neurological and muscular symptoms, including convulsions and cramping. Patients who have experienced hypomagnesemia also have a higher rate of coronary artery disease than patients without the mineral deficiency.
Some patients, however, may be allergic to proton pump inhibitors.
Over the last two decades, reports of PPI patients experiencing acute interstitial nephritis, a condition in which structures in the kidney swell, have emerged in the medical literature. More recent research seems to have confirmed these early suspicions. In 2007, gastroenterologists in Colombia reviewed 60 case reports of interstital nephritis publicized between 1970 and 2006, all of which had initially been associated with proton pump inhibitor usage. In 21 of the 60 cases, the researchers were able to determine that PPI use had been the “certain or probable” cause of kidney complications.
In December of 2014, the FDA added a warning about acute interstitial nephritis to the labels of every proton pump inhibitor. But even at this early stage of research, many doctors were already warning us about the wider implications proton pump inhibitors may have for kidney function. New studies have linked PPIs to chronic kidney disease and kidney failure.
Today, multiple patients have filed lawsuits against PPI manufacturers over kidney failure. Legal experts believe that thousands of other PPI users may also be able to file suit – with some even suggesting the possibility of settlements.
Of course, stomach acids are important, helping our bodies digest foods and protecting the gastrointestinal tract from pathogens. With less gastric acid doing its job, people on proton pump inhibitors are probably more likely to develop infections, including the potentially deadly Clostridium difficile (or C. diff), and may be at an increased risk of food poisoning. Several studies have also found that users of proton pump inhibitors are at an increased risk of contracting pneumonia.
Discontinuing use of the drugs, though, can be difficult, leaving patients with distressing and painful surges in stomach acids. Many people are left stuck between two seemingly impossible choices: continue taking PPIs, and risk experiencing severe side effects or discontinue the drugs and relapse to their prior gastrointestinal condition.
Although proton pump inhibitors are some of the most widely-prescribed medications in the world, health experts advise taking these medications only for limited periods of time.
Over-the-counter PPIs, packaged at lower doses than prescription options, should only be taken in 14-day courses of treatment, with a max of 3 courses of treatment per year, according to the US Food & Drug Administration. That suggestion came soon after proton pump inhibitors had been linked to an increased risk of bone fractures and osteoporosis.
In 2010, the FDA announced that both prescription and OTC versions of the drugs would be required to carry a warning about bone health. After reviewing the prescription guidelines for OTC proton pump inhibitors, including the suggested limit to three 14-day courses of treatment every year, the FDA decided that a warning about broken bones wouldn’t be necessary for over-the-counter PPIs.
The risk of fractures, however, remains an issue, especially for patients over the age of 50. In these patients, researchers believe that proton pump inhibitors can increase the risk of broken bones, particularly bones in the hip, wrist or spine. While the precise cause has yet to be determined, some experts suggest that proton pump inhibitors impair the body’s ability to absorb calcium and vitamin B12, two nutrients critical to bone density.
Continue Reading: Proton Pump Inhibitor Lawsuit Settlements
