Prilosec Lawsuit Follows Studies Linking Proton Pump Inhibitor to Kidney Disease

Recent studies suggest a common type of heartburn medication called proton pump inhibitors (PPIs) are linked to increased risks of chronic kidney disease. This class of drugs includes popular brands such as Prilosec, Nexium and Prevacid.

In February of 2016, the Journal of the American Medical Association (JAMA) published results of a study showing that people who take Prilosec and other Proton Pump Inhibitor (PPI) medications may have a 20 to 50 percent increased risk of chronic kidney disease. The study indicates that the longer the medication is taken, the greater the risk.

Researchers found the risk of end-stage kidney failure is 96 percent higher for those taking PPIs, particularly those using the drugs for many months or years. Some experts are calling the increase of kidney issues in the American public an “epidemic.”

An estimated 15 million Americans were prescribed PPIs in 2013 at a cost of more than $10 billlion. However, the number of those at risk of health problems is likely to be much higher because most of these drugs, including Prilosec, Nexium, and Prevacid, are now available over-the-counter.

Lawsuits filed against PPI manufacturers such as AstraZeneca claim the companies have failed to provide adequate warnings about the risks their product presents. The Prilosec lawsuit claims allege companies knowingly hid dangers of their medications from the public. The uncovered kidney damage risks could affect thousands of Americans.

AstraZeneca has faced legal issues in the past. In fact, the company settled a $20 million class action lawsuit related to deceptive marketing of Nexium. The lawsuit claimed the drug company “defrauded” consumers with dishonest advertising. Prilosec Lawsuit Settlements are now being considered.

Prilosec Lawsuit & PPI Warnings

The recent study’s results indicate that the longer PPIs like Prilosec are taken, the greater the risk to the patient. Heavy use in a short amount of time can also be dangerous. Patients who take the medication more than once per day face a greater risk.

This information is based on a number of broad studies. Researchers in one study examined the records of more than 248,000 people treated in a Pennsylvania hospital system.

In another study, assessing the safety of these medications, researchers analyzed information from the Department of Veterans Affairs national databases.

After identifying over 170,000 new users of PPIs, they compared them to over 20,000 new users of histamine H2 receptor blockers, an alternative class of drugs also used to suppress stomach acid. Over five years of follow-up, results showed that 15 percent of people using PPIs were diagnosed with chronic kidney disease. After controlling for other factors, this translated to a 28 percent increased risk of developing kidney disease for PPI users.

PPI Side Effects & Complications

Even before recent damaging information came to light, PPIs were associated with short-term kidney problems like acute kidney injury and an inflammatory kidney disease called acute interstitial nephritis.

In one study at Johns Hopkins University, over 10,000 adults with normal kidney function were monitored from 1996 to 2011. They found that PPI users were between 20 and 50 percent more likely to develop chronic kidney disease than non-PPI users.

This discovery was mirrored in a second study, in which over 240,000 patients were followed from 1997 to 2014. One out of four of the kidney patients had been previously treated using a PPI.

In both studies, people who used a different class of medications to suppress stomach acid, such as H2-blockers, did not share the same risk of developing kidney disease. Also, among the total group of patients, PPI use was linked to a 76 percent increased risk of dying prematurely.

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PPI Overuse & Prilosec Injury

All the new research indicates long-term use of this class of medication used to treat heartburn, acid reflux, and ulcers may lead to an increased risk of kidney disease and kidney failure.

The results of the most recent study highlight that patients should use PPIs “only when it is medically necessary,” and should limit duration of exposure to the minimum necessary to treat their medical condition.

The lead author of the JAMA study states, “Patients should only use PPIs for FDA-approved indications, and not to treat simple heartburn.” The study concluded that, “It is very reasonable to assume that PPIs themselves can cause chronic kidney disease.”

Gastroenterologists are already cautious in prescribing PPIs, as they’ve been linked to other health problems, including bone fractures and an increased risk of infections like C. difficile. Doctors and experts are concerned that many people continue to use the drugs long after symptoms subside, largely because they are so readily available over-the-counter.

Typically, doctors recommend patients with acute symptoms take the drugs for two weeks, while those with more substantial symptoms may need them for six to eight weeks followed by a reassessment. Some Prilosec Lawsuit files suggest doctors are recklessly prescribing PPIs.

Dr. Arora, whose team completed a seven-year study of PPIs, says that PPIs are often “prescribed outside of their approved uses.” Studies have shown that as many as 70 percent of those people don’t need the drugs, and 25 percent who use them on a long-term basis could stop without developing symptoms.

What is Prilosec?

Prilosec, produced by AstraZeneca, was the first FDA approved Proton Pump Inhibitor (PPI), marketed to treat gastroesphageal reflux disease (GERD) and peptic ulcer disease (PUD).

It is estimated that the company’s sale proceeds from Prilosec topped $6 billion by the year 2000. Up to 14 percent of adults in the U.S. have been prescribed Prilosec or other PPI medications, and many more may have taken over-the-counter medicines as well.

In 2001, when Prilosec’s patent expired, AstraZeneca introduced a similar PPI drug called Nexium. Shortly after, in 2003, Prilosec became available over-the-counter. Most of the popular PPI medications, including Prilosec, Nexium and Prevacid, are now available over-the-counter.

PPI Medication Risks

The PPI group of medications now includes nine drugs, including the following:

  • Prevacid
  • Prilosec
  • Nexium
  • Protonix
  • Aciphex
  • Zegerid
  • Dexilent
  • Kapidex

FDA Prilosec Warnings

Concerns about the safety of Prilosec emerged as early as 2002. Recent results of studies are even more troubling as they have shown the risk in the consumer population may worsen over time.

  • Bone Fractures: A 2006 study published in the Journal of American Medical Association (JAMA) showed that long-term Prilosec use increased the risk of hip fractures, particularly in the elderly. In 2010, the FDA echoed a prior warning, and issued a new warning to consumers, stating that Prilosec may cause an increased risk in bone fractures.
  • Dependency: In 2009, a Danish study showed that Prilosec use may lead to a dependency on the medication due to a “rebound” effect of stomach acid if a patient stops taking the medication. The study had concerns with a number of patients experiencing a “withdrawal” from the drug.
  • Blood Issues: In 2011, the FDA issued another warning, this time regarding the long-term risk of Prilosec causing hypomagnesemia. Such low magnesium levels in the blood may cause neurological, muscular, and cardiac effects.

PPI Chronic Kidney Disease

According to the American Society of Nephrology, chronic kidney disease is increasing in the United States. More than 20 million Americans, or more than 13 percent, are now affected by the disease, which also can lead to cardiovascular problems and greater than normal risk of death.

Chronic Kidney Disease, also known as chronic renal failure, occurs when long-term damage is done to the kidneys, reducing the ability to filter toxins and metabolic products from the bloodstream. The kidneys become damaged and they are unable to filter blood as they should. Diabetes and high blood pressure are two common risk factors for kidney disease.

Chronic kidney disease can lead to total kidney failure and the need for dialysis or a kidney transplant. Chronic kidney failure is progressive and will get worse over time. Symptoms of kidney failure should be reported to a medical professional. Chronic Kidney Disease may present with symptoms such as:

  • Swelling
  • Fluid in lungs
  • Arrhythmia
  • Hypertension
  • Electrolyte abnormalities
  • Nausea and Vomiting
  • Loss of Appetite
  • Inability to urinate
  • Fatigue

Prilosec Risks & Side Effects

Several safety concerns have been identified over the years. In 2015, one study indicated that PPI drugs may increase the heart attack risk by up to 21 percent, even if the patients had no history of heart disease. Side Effects of PPI drugs can include:

  • Pain in joints or muscles
  • Headaches
  • Intestinal disruption
  • Nausea
  • Rashes
  • Anxiety

More serious adverse events may include:

  • Heart attack
  • Liver failure
  • Hypomagnesemia (low magnesium levels)
  • Osteoporosis and bone fractures
  • Liver toxicity
  • Cardiac issues

Prilosec Lawsuit Settlements

Although modern medicine seems like the best option to treat uncomfortable symptoms, patients should take steps to ease heartburn-related symptoms through lifestyle changes. This can be as simple as diet change. Losing weight, avoiding high-fat foods and avoiding eating late at night can be very helpful.

It is also worth noting that medications such as Zantac and Pepcid, which combat heartburn by blocking histamine production, do not appear to cause similar issues. PPI medications affect the body and treat symptoms differently than other antacid or anti-ulcer drugs. Experts urge patients and clinicians to discuss the “potential alternative regimens” before riskier drugs like Prilosec are prescribed.

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Joe Lyon is an experienced Cincinnati, Ohio Product Liability Attorney, taking Prilosec lawsuit claims and pharmaceutical injury cases nationwide. If you or a loved one has suffered an injury after taking Prilosec, contact the Lyon Firm for a free consultation regarding a potential Prilosec lawsuit.