Prilosec PPI Side Effects

The heartburn medication Prilosec (Omeprazole), which is one of nine proton pump inhibitor (PPI) medications, has been linked to bone fractures, heart attacks, cardiac birth defects and severe kidney disease, including Prilosec kidney failure and Prilosec renal failure. Long-term use of Prilosec has been associated with a tripled risk of kidney inflammation, or nephritis. This over-the-counter antacid medication is commonly used to treat heartburn and gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus.

Prilosec was the first member of the Proton Pump Inhibitor (PPI) group of medications introduced by manufacturer AstraZeneca and FDA-approved in 1988. Originally called Losec, the PPI is used to treat gastroesphageal reflux disease (GERD) and peptic ulcer disease (PUD) by blocking the proton pumps that release acid into the stomach.

Because Prilosec is available over the counter, it is potentially more at risk of being overused than prescribed PPI medications. Researchers have noted that these drugs are generally viewed as safe and may be over-prescribed and continued for long periods without being necessary, Reuters Health reported.

A JAMA Internal Medicine study (January 2016) indicates that patients should use PPIs only when medically necessary. Gastroenterologists are already cautious in prescribing PPIs, as they've been linked to other health problems, including bone fractures and 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. Dr. Morgan E. Grams, a kidney specialist at Johns Hopkins and another author of the JAMA study also told CBS News that patients who require a long course of PPIs should routinely monitor their kidney function.

A study from the University of Copenhagen and published in Gastroenterology (July 2009) 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.
  Prilosec has been linked to the increased risk of hip, wrist and spine fractures. The FDA in 2010 warned doctors and the public that consumers who had taken high doses of Prilosec and other PPI drugs for longer than a year were most at risk. The FDA warning came four years after a study published in the Journal of the American Medical Association (JAMA) found that patients over 50 years old who took PPIs, including Prilosec, for more than a year were 2.65 times more likely to break a hip.
  In June 2015 PLOS published a study from Stanford University that showed PPI medications may increase the heart attack risk by up to 21 percent, even if the patients had no history of heart disease. The FDA issued a warning in 2011 regarding Prilosec's risk of causing hypomagnesemia, or a magnesium deficiency, after long-term use. This condition can cause neurological, muscular, and cardiac complications.
  In April 2016, the Journal of the American Society of Nephrology (JASN) reported that PPIs --including Prilosec-- may lead to an increased risk of kidney disease and kidney failure. Researchers said that people who take these popular PPI drugs are more likely to develop kidney failure and 28 percent more likely to develop chronic kidney disease, particularly if the drugs are taken for a long time.

In January 2016, a study published in JAMA Internal Medicine found a 20-50 percent increased risk of chronic kidney disease (CKD) associated with Prilosec 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.
  Prilosec kidney failure lawsuits have been filed against AstraZeneca, the manufacturer. Investigation has begun for hundreds of claimants who allege the heartburn drug and other PPIs have caused chronic kidney disease, acute kidney injury, acute interstitial nephritis, renal failure, and kidney failure.

Prilosec 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.

Approximately 15 million people in the US alone are taking either over-the-counter or prescription PPI medications. In 2000 Prilosec generated $6.1 billion for AstraZeneca before its patent expired the following year and the drug company introduced Nexium, the "next generation" formulation of Prilosec. In 2013 Prilosec became available over-the-counter (OTC) and sales that year were about $400 million, as reported by Medscape. It continues to be one of the top five OTC proton pump inhibitor drugs.
 

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Last updated on Oct-14-20