Proton Pump Inhibitors Linked to Gastric Cancer, Severe Kidney Disease and Bone Fractures

Proton pump inhibitors (PPIs) are a group of drugs mainly used to relieve symptoms of acid reflux, or gastroesophageal reflux disease. PPIs have been linked to an increased risk of bone fractures, heart attacks, cardiac birth defects (only in Prilosec), and more recently chronic kidney disease (CKD). The risk of proton pump inhibitor side effects has been found to increase with long-term use. The FDA has announced label changes that will reflect the increased risk of a proton pump inhibitor fracture, particularly PPI hip fracture. No action by the agency has yet been taken involving Proton Pump Inhibitor kidney damage or PPI renal damage.

Gastroenterologists are already cautious in prescribing PPIs as they've been linked to other health problems, such as an increased risk of intestinal infections such as Clostridium difficile infection, and pneumonia, Dr. Ziyad Al-Aly of the Clinical Epidemiology Center at the VA Saint Louis Health Care System, told CBS News.
  Proton pump inhibitors are used to treat heartburn. They are also used to treat gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus.

Prescription PPI medications in the proton pump inhibitor class include: (Generic name in parentheses)

• Nexium(esomeprazole)
• Dexilant (dexlansoprazole)
• Prevacid (iansoprazole)
• Prilosec (omeprazole)
• Zegerid (omeprazole)
• Protonix (pantroprazole)
• Aciphex (rabeprazole)
• Vimovo (naproxen and esomeprazole magnesium)

Proton pump inhibitors sold over-the-counter include:

• Prilosec OTC (omeprazole)
• Zegerid OTC (omeprazole)
• Prevacid 24HR (iansoprazole).

Researchers have found that people who take the popular PPI drugs are more likely to develop kidney failure and chronic kidney disease, particularly if the drugs are taken over a long time. Because PPIs are generally viewed as safe, they may be over-prescribed and continued for long periods without being necessary, Reuters Health reported.

Because some PPI medications are sold over-the-counter, they are potentially more at risk of being overused than prescribed PPI medications.

Chronic kidney disease is increasing in the US, with more than 20 million Americans now suffering with it, according to the American Society of Nephrology.
  January 2016: A study published in JAMA Internal Medicine found a 20-50 percent increased risk of chronic kidney disease (CKD) associated with Nexium and other antacid drugs. The risk of a decline in kidney function was 32 percent higher for people taking PPIs and the risk of new cases of chronic kidney disease was 28 percent higher, according to Reuters Health. The JAMA study involved more than 20,000 people from national VA databases who recently took PPIs. This group was compared to almost the same amount of people who were taking H2 blockers. The study team concluded that people taking PPIs were at a much higher risk of new kidney problems than those people taking H2 blockers.

The JAMA study indicates that patients should use PPIs only when medically necessary. Dr. Morgan E. Grams, a kidney specialist at Johns Hopkins and another author of the JAMA study told CBS News that patients who require a long course of PPIs should routinely monitor their kidney function.

2015: Two studies suggested a link between PPIs and CKD. Dr. Pradeep Arora, a nephrologist and associate professor at the SUNY Buffalo School of Medicine and Biomedical Science in Buffalo, NY., said "It is very reasonable to assume that PPIs themselves can cause chronic kidney disease." Researchers also found that people taking a PPI had nearly twice the risk of dying prematurely.

The second study was conducted by researchers at Royal Brisbane and Women's Hospital in Australia, and Johns Hopkins University in Baltimore. They followed more than 10,000 adults with normal kidney function from 1996 to 2011 and found PPI users were up to 50 percent more likely to develop chronic kidney disease than non-PPI users.

2009: A study conducted in Copenhagen and published in Gastroenterology reported that PPI use may produce a "rebound"acid effect, likening the condition to "dependency"on the medications. Researchers found that patients have almost impossible difficulties in stopping PPIs because the medications eventually cause the same problems they are supposed to treat. This phenomenon, called "rebound acid hypersecretion," can occur after taking prescription-strength PPI medication for just two months. Researchers concluded that this rebound effect can continue for up to three months after discontinuing the PPI.
  Proton Pump Inhibitor kidney failure lawsuits have been filed against AstraZeneca—the Nexium and Prilosec manufacturer—and Takeda Pharmaceuticals, which makes Prevacid. Nexium patients claim that AstraZeneca failed to warn physicians and patients of the increased risks of kidney damage and renal failure. Further, if AstraZeneca had properly warned of the risks, patients would have chosen a different medication and/or would have had regular kidney function monitoring.

In 2017, a lawsuit files against AstraZeneca and Proctor & Gamble, alleging that use of Nexium and Prilosec caused a woman to develop chronic kidney disease. The lawsuit, filed by Wanda Stafford, claims the companies failed to warn consumers about the risk of side effects linked to the medications. The lawsuit seeks punitive and compensatory damages.
  Long-term and/or high dose use of proton pump inhibitors has been linked to an increased risk of fractures, including hip, wrist and spine fractures. A study examining 145,000 people in England found patients who used the medications for more than a year had a 44 percent higher risk of hip fracture than people who did not use the medications. The largest risk was seen in people who took high doses of the drugs for more than a year. In that group, the risk of hip fractures was twice as great as patients who did not use the medications.

An editorial accompanying studies in the May issue of the Archives of Internal Medicine noted that proton pump inhibitors have US sales of $13.9 billion annually. The same editorial argues that proton pump inhibitors have been over-prescribed for inappropriate uses.
  According to the FDA news release (05/25/10), the FDA's review of several studies, "found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more." FDA notes the majority of people evaluated were 50 years of age or older and this age group showed an increased risk of fracture. Although the risk was observed in people using prescription proton pump inhibitors, the label on over-the-counter medications is also being changed as a precaution.

Over-the-counter proton pump inhibitors are recommended only for 14 days of continuous use.

Approximately 15 million people in the US alone are taking either over-the-counter or prescription PPI medications, according to CBS News. In 2013, the PPI Nexium was the second-best selling drug in the pharmaceutical industry, generating over $6.1 billion in sales worldwide for AstraZeneca, as reported by Medscape.
 

Proton Pump Inhibitor (PPI) Legal Help

If you or a loved one has suffered kidney disease or bone fractures as a result of using any of the above mentioned products, please click the link below and your complaint will be sent to a Drug and Medical Device lawyer who may evaluate your claim at no cost or obligation.

 

Last updated on Jun-27-21