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Inadequate Warnings of Serious Side Effects of Proton Pump Inhibitors

Feb 8, 2017
Poor Warnings of Side Effects of Proton Pump Inhibitors

Millions of Americans suffer from heartburn, acid reflux and similar digestive conditions and many of them take a proton pump inhibitor (PPI) medication to provide relief from the condition.

PPIs ease heartburn and acid reflux by causing the stomach to produce less acid. But these medications can have serious side effects, as has been shown by research and indicated by mounting lawsuits against the makers of PPIs. A number of these lawsuits have been consolidated in a multidistrict litigation (MDL), with more cases under investigation that could result in additional lawsuits.

The drug side effects attorneys at Parker Waichman note that PPI use has been linked to a variety of health risks, including kidney disease, fractures, Clostridium difficile infection, and pneumonia. Recent new research reports that PPI use increases the risk for dementia in elderly patients.

Kidney Disease and Other Health Risks

About 15 million Americans have a prescription for a PPI. Many of the drugs are also available in over-the-counter formulas, so the number of people who use them is likely much higher than 15 million, according to CNN. PPIs became popular because they relieve symptoms quickly and were thought to have low toxicity.

The issue in many PPI lawsuits is that PPI use-including the drugs Prevacid (lansoprazole), Nexium (esomeprazole), and Prilosec (omeprazole)-is linked to kidney injury and kidney disease. But other serious health effects have been reported. People taking PPIs experience diarrhea and increased risk of bone fractures. The fracture risk increases at higher doses and a longer period of taking the PPI. Hip fractures can be painful and debilitating, and for older individuals, the fracture may even prove life threatening. The individual may need a hip replacement, which involves serious surgery and requires a lengthy recovery and physical therapy.

Studies published in 2015 and 2016 suggest that the risk for kidney injury and acute interstitial nephritis increases when a PPI such as Prevacid is used for 30 days or longer. Another new study, by scientists from the Australian National University (ANU), reports that Australians who take PPIs drugs have a 70 percent higher chance of being admitted to hospital with infectious gastroenteritis.

The product guide for Prevacid on Takeda USA website references acute interstitial nephritis on page seven of a medication guide that runs that runs 40 pages: "Acute interstitial nephritis has been observed in patients taking PPIs including PREVACID." The medication guide attributes the nephritis to an "idiopathic hypersensitivity reaction," and recommends that the patient discontinue Prevacid if acute interstitial nephritis develops. The Canadian medication guide for Prevacid is 95 pages long and reference to kidney issues could not be readily found. The Prevacid medication guide posted by U.S. Food and Drug Administration (FDA) does not make reference to kidney dysfunction, though it does caution about diarrhea and bone fractures.

Plaintiffs in PPI side effects lawsuits allege that they were not warned about the potential for kidney disease or kidney injury. A plaintiff, who filed a kidney disease lawsuit in federal district court in New York, says he began taking Nexium and Prevacid in 2006. According to the legal complaint, he later suffered acute kidney injury and he will need medical care and monitoring for the rest of his life.

Treating Heartburn and Acid Reflux

Treating Heartburn and Acid Reflux

Many experts say most people should not be taking PPIs for extended periods. The Mayo Clinic says there are lifestyle actions people can take to avoid or ease heartburn without relying on continuous use of PPIs or other medication. Among the recommendations:

  • maintain a healthy weight to avoid extra pressure on the abdomen
  • avoid foods and drinks that trigger heartburn. Common triggers such as fatty or fried foods, tomato sauce, alcohol, chocolate, mint, garlic, onion, and caffeine may make heartburn worse
  • eat smaller meals
  • do not lie down soon after a meal. (Wait at least three hours after eating before lying down or going to bed.)
  • elevate the head of your bed
  • quit smoking. Smoking decreases the lower esophageal sphincter's ability to function properly.

Antacids such as Maalox, Mylanta, Gelusil, Gaviscon, Rolaids and Tums may provide relief for symptoms, though antacids do not heal an inflamed esophagus damaged by stomach acid. And overuse of antacids can cause side effects like diarrhea or constipation. The Mayo Clinic recommends that patients should use any of these medications for the shortest period and at the lowest effective dose.

Legal Help for Kidney Injury or Health Effects Linked to PPI Use

If you or someone you know has taken Prevacid or another proton pump inhibitor and suffered kidney disease, gastroenteritis, or other health effects, you may be entitled to compensation. Please contact Parker Waichman LLP for a free, no obligation case evaluation. Fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).


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