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Mass Tort Law

PPI (Proton-Pump Inhibitors)


Proton Pump Inhibitors (PPIs) and Severe, Chronic Kidney Disease

Were you or a loved one prescribed Nexium, Prilosec or Pepcid and now suffer from severe, chronic kidney disease (CKD)? If so, you may be entitled to financial compensation based upon claims that the drugs’ manufacturers knew of the increased risk of CKD (including kidney failure) associated with their proton pump inhibitor (PPI) products but did not warn the public.

What are PPIs and What Do They Do?

Proton pump inhibitors (PPIs) are a class of acid-reducing drugs. They are most commonly used, whether prescribed or over-the-counter (OTC) to treat frequent heartburn (described as happening two or more times per week), certain ulcers, esophageal inflammation and gastroesophageal reflux disease (GERD). Frequent heartburn is one of the common symptoms of GERD, a condition found most often in those 50-years-old or older and pregnant women. Roughly one-quarter to one-third of adults in the United States will experience GERD symptoms at some time in their lives.

PPIs work by blocking an enzyme found in the stomach wall that is responsible for acid production. When the enzyme is blocked, the stomach produces less acid and the symptoms of GERD and other related conditions are typically reduced. This cuts down on the amount of stomach acid that can enter the esophagus. Acid in the esophagus is the cause of heartburn.

Another use for PPIs is the treatment of open sores (ulcers) found in the small intestine and stomach. These ulcers are aggravated by the excess stomach acid and so, the use of a PPI can keep new ulcers from forming, as well as giving the ulcers present a better chance of healing. Typically, those who are experiencing regular heartburn benefit more from antacid products, such as Alka-Seltzer or H2 blockers, such as Zantac. These options provide more immediate relief, whereas PPIs may take several days to provide symptom relief.

Brands of PPIs

We are looking at three brands of PPIs and the people who have been injured by them. Each one has a different active ingredient and is made by many different manufacturers. Some of these PPIs are also available as generics, such as Prilosec and Pepcid. Nexium is available as an OTC drug.

  • Prilosec (omeprazole) – approved in 1989; made by AstraZeneca Pharmaceuticals
  • Nexium (esomeprazole) – approved in 2005; made by AstraZeneca Pharmaceuticals
  • Pepcid (famotidine) - approved in 1986; made by Valeant Pharmaceuticals

The active ingredients in the generic and OTC forms of all three drugs are the same as those found in the prescription version. One main difference is that OTC customers are told that proper dosage is only around 14 days every four months.

PPIs and CKD

Properly functioning kidneys are essential for good health. The kidneys, bean-shaped organs found close to the middle of the back below the rib cage, are one of the body’s major waste filtration systems. They remove waste and extra water from the bloodstream and convert it to urine, which is eliminated via the bladder, etc.

Damaged or poorly-functioning kidneys cannot perform this vital filtration function, which allows toxins to build in the bloodstream and can lead to severe health issues. If kidney function is reduced far enough, it can lead to kidney failure (renal failure) and even death.

Chronic kidney disease (CKD) is a slow-moving condition. The symptoms show very gradually and are often quite subtle, which leads to delays in diagnosis. Untreated CKD often leads to renal failure and death. Sadly, almost 26 million Americans live with CKD, according to data from the National Kidney Center.

Signs and symptoms of CKD include:

  • Urinating more frequently or in greater amounts
  • Urinating less frequently or in smaller amounts
  • Difficulty urinating
  • Blood in urine
  • Foamy or bubbly urine
  • Swelling of legs, feet, face or hands
  • Skin rash/itching
  • Leg, back or side pain
  • Metallic taste in mouth
  • Breath that smells of ammonia
  • Nausea and vomiting
  • Feeling cold
  • Shortness of breath
  • Dizziness and trouble concentrating
  • Fatigue

Is there a Test for CKD?

Actually, there are three tests your doctor can run to see if you have CKD. They are:

  • Blood test to check for problems with waste removal
  • Urine test to check for problems with waste removal
  • Blood pressure test

What is the Mechanism by which PPIs Cause CKD?

At present, scientists have not been able to establish a clear cause-and-effect connection between these drugs and chronic kidney disease. However, studies have shown that there is a correlation between the use of PPIs and the occurrence of CKD, which suggests a link. This link comes in the form of an inflammatory condition known as acute interstitial nephritis.

PPIs have been shown to cause this inflammation. Scientists found that patients who experience acute interstitial nephritis several times have a great chance of developing CKD. These studies also show that PPI use is linked to magnesium deficiency. This can be damaging to the kidneys, too. The U.S. Food and Drug Administration (FDA) issued a warning of the risk of magnesium deficiency following the PPI use in 2010.

FDA Warns of Link between PPIs and Interstitial Nephritis

The FDA again became involved in 2014 when it required new warnings for PPIs and the link between their use and interstitial nephritis. The warning read:

“Acute interstitial nephritis has been observed in patients taking PPIs including Prilosec. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to idiopathic hypersensitivity reaction. Discontinue Prilosec if acute interstitial nephritis develops.”

So, What Exactly is Interstitial Nephritis?

This medical condition creates inflammation between the tubules of the kidney. The kidney tubules are canals that reabsorb certain minerals back into the blood stream while collecting and transporting urine. Interstitial nephritis may range from mild to severe and from acute (sudden onset) to chronic. Left untreated, interstitial nephritis may create serious complications, including CKD, renal failure and death.

Interstitial Nephritis Symptoms:

  • Decreased urination
  • Blood in the urine
  • Water retention/bloating/weight increase
  • Fever
  • Fatigue
  • Confusion
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Inflammation
  • High blood pressure

You should seek immediate medical attention if you or a loved one is experiencing these symptoms. The earlier the diagnosis and treatment, the better chance you have of avoiding serious complications.

FDA Actions

The agency has issued warnings about other PPI side effects (see list below). However, the FDA has been noticeably quiet on the issue of PPI use and kidney disease risks, other than interstitial nephritis. The likely reason is that the studies suggesting PPI use as a risk factor for CKD are relatively new. Following the list of other FDA warnings is a selection of these studies.

Other FDA Warnings for PPI Side Effects

Some Studies of PPI Use and the Risk of CKD

These studies show that PPIs are among the biggest-selling drugs in the U.S., with 2015 sales hitting almost $9.5 billion. One study published in the Journal of the American Medical Association (JAMA) earlier this year points to the possibility that PPIs may also be overprescribed. Evidence suggests that 20% - 70% of PPI prescriptions are written for patients who do not exhibit a medical need. PPI overuse could even be higher than this, with the availability of OTC versions.

The JAMA study found that people taking PPIs were roughly 20% - 50% likelier to develop CKD than non-PPI users. This risk increased for patients taking the drugs twice daily, as opposed to just once per day. The scientists conducting the study at Johns Hopkins University based their conclusions on data collected from 10,500 PPI users who used the drugs between 1996 and 2011.

The Journal of the American Society of Nephrology published a study that suggests people’s risk of developing kidney diseases is greater with PPI use of one year or longer. The study also suggests that those who take PPIs for one to two years have a risk factor for kidney failure that is three times higher than for those who took the same drugs for a month or less.

Patients who take PPIs for longer than one year seem to be at a greater risk of developing kidney diseases. A study published last month in the Journal of the American Society of Nephrology suggested patients who took PPIs for one to two years were at a three-fold risk or higher for kidney failure compared to patients who took PPIs for one month or less. This same study also showed that those using PPIs had a 28% greater risk of developing CKD. Based on this information, the study’s authors recommend that people should only use PPIs when the drugs are medically necessary. They also recommend that the drugs are used for the shortest possible time.

The last study we’ll look at here was published in April 2015 in CMAJ Open. This study was conducted using data from almost 300,000 older adults in Canada who began PPI use between 2002 and 2011. The conclusions were stark. PPI users undergoing longer-term treatment were 2.5 times more likely to have an acute kidney injury than non-PPI users. They were also 3 times more likely to develop interstitial nephritis.

The Time to Act is Now

If you or a loved one took Prilosec, Nexium or Pepcid and suffered any of the complications listed above, including death, now is the time to act. How long you have to file a lawsuit, also known as the statute of limitations, is different in every state. If you aren't sure if you can still file a claim, don't worry. We are here for you and will do whatever it takes to help you with your case. We're on your side.

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