Proton Pump Inhibitors

What is a Proton Pump Inhibitor?

Proton Pump Inhibitors are a class of powerful acid reduction drug that can be sold over-the-counter or as a prescription. They can be used to alleviate short-term symptoms or for relieving symptoms associated with chronic issues. Patients take PPIs for everything from acid reflux, heartburn and peptic ulcers, to gastritis, esophagitis and stomach tumors.

Doctors prescribe some 119 million Proton Pump Inhibitor prescriptions each year for symptoms of gastroesophageal reflux disease, heartburn, and acid reflux. “The Purple Pill,” Nexium, made nearly $5 billion by claiming that their drug outperformed the competition – but the FDA warned in 2012 that PPIs have been linked to drug resistant intestinal infections. Medical experts continue to study the risk of other proton pump inhibitor side effects such as bone fractures, pneumonia, vitamin B-12 deficiency, cardiovascular disease, and kidney failure.

List of Proton Pump Inhibitors

Proton Pump Inhibitor medications include:

  • Omeprazole (Prilosec) manufactured by AstraZeneca
  • Esomeprazole (Nexium) manufactured by AstraZeneca
  • Lansoprazole (Prevacid) manufactured by Takeda Pharmaceuticals
  • Dexlansoprazole (Dexilant and Kapidex) manufactured by Takeda Pharmaceuticals
  • Pantoprazole (Protonix) manufactured by Wyeth Pharmaceuticals
  • Rabeprazole (Aciphex) manufactured by Eisai

How do Proton Pump Inhibitors Work?

Normal amounts of stomach acid aid the body in digesting food and killing germs. However, this acid can become corrosive, damaging the stomach and irritating the esophagus, when produced in abundance. Proton Pump Inhibitors signal acid-forming cells in the stomach lining to decrease gastric acid production.

While it’s currently unclear how this class of drug causes adverse side effects, one theory is that the medication causes a plummeting of magnesium levels – which is tied to more than 300 enzyme reactions in the body from nutrient metabolism and bone formation, to proper kidney function and white blood cell production.

Alternatives to Proton Pump Inhibitors

CBS News reports that “as many as 70 percent of these prescriptions have been handed out inappropriately, and 25 percent of long-term users could stop taking the medication without suffering increased heartburn or acid reflux.” Mild occurrences can be treated through diet modification or with products like TUMS, Rolaids and Alkaseltzer – which do not carry the same risk of unwanted side effects. H2 blockers (like Pepcid or Zantac) can treat heartburn and acid reflux long-term. Patients with severe symptoms may elect to have one of a number of surgical procedures done to fix the root cause of their suffering, rather than merely mask the symptoms with drugs.

Proton Pump Inhibitor Side Effects

Common side effects of Proton Pump Inhibitors include:

  • Headaches
  • Skin rashes
  • Dizziness
  • Anxiety
  • Constipation
  • Severe diarrhea
  • Malabsorption, and
  • Joint pain.

More serious side effects have been identified by researchers, such as:

  • Heart attack – Stanford researchers assessed the medical records of 2.9 million people and found a 20 percent increased risk of heart attacks for Proton Pump Inhibitor users. By comparison, users of H2 blockers (like Zantac and Pepcid) did not correlate with any elevated risk.
  • Kidney failure and disease –Scientists from Washington University in St. Louis looked at nearly 200,000 veteran records and concluded that patients taking PPIs had a 96% increased risk of kidney failure and a 28% increased risk of chronic kidney disease compared to H2 receptor blocker patients.
  • Bone fractures – University of Maryland scientists reported that drugs like Prevacid, Nexium and Prilosec increased the risk of bone breaks (particularly the wrist, hips, spine and forearms) by 30 percent in people who used the medications for over a year.
  • Dementia – German researchers found a 1.4-fold increased risk of dementia among regular PPI users.

FDA safety communications

FDA safety communications warn of adverse side effects, particularly with long-term use. In 2010, they pointed to the increased risk of bone fractures among users. In 2011, they warned of low magnesium levels associated with PPIs. In 2012, they warned of an increased risk of Clostridium difficile-associated diarrhea with PPI use.

Proton Pump Inhibitor Lawsuit

If you suffered one of the adverse health effects mentioned, you may have a legitimate claim for compensation to cover your medical bills, lost wages, and emotional suffering. Following the publication of these studies and FDA warnings, Proton Pump Inhibitor lawsuits have surfaced in courts across the country.

In 2014, 55 plaintiffs contended that they suffered bone fractures related to their use of Nexium in MDL-2404. Central California District Judge Dale S. Fischer struck down the mass tort, ruling that the causation was “not definitive” and that the “expert testimony” was not reliable, as the doctor did not specialize in orthopedics. Even so, at least half the plaintiffs are awaiting individual trials.

In 2015, PPI manufacturers lost three lawsuits alleging the superiority of their products over less expensive generic drugs without evidence to back their claims. AstraZeneca was ordered to pay $20 million in one suit and $7.9 million in another. Teva Pharmaceuticals paid out $24 million for engaging in anti-competitive practices.

In 2016, more than a dozen lawsuits alleging kidney disease linked to PPIs have appeared, with more expected to follow.  Plaintiffs have asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate Multi-District Litigation centralized in the U.S. District Court for the Middle District of Louisiana.

Additional Resources For Proton Pump Inhibitor Dangers