Lawsuits forming against PPI manufacturers

Lawsuits are being filed against the manufacturers of some of the most popular proton pump inhibitors (PPIs), including AstraZeneca who makes Prilosec and Nexium, and Takeda Pharmaceuticals, the maker of Prevacid.

Though still in the early stages of investigation, the lawsuits allege the manufacturers failed to warn the public about serious potential side effects of proton pump inhibitors, including kidney disease, CKD and kidney failure (renal failure).  These class action lawsuits may include large cash claims from settlements.   If you or someone you love was harmed by Prilosec, Nexium or Prevacid, our lawyers and attorneys offer a free case evaluation. Call us today at 1-800-214-1010 or use the form on the right-hand side of the screen.

Studies show popular heartburn drugs could cause kidney failure

The heartburn medications known as proton pump inhibitors (PPIs) are some of the best-selling pharmaceutical drugs in the United States, reaching about $9.5 billion in sales last year.

As some of the highest-selling, they are also overprescribed, suggests a study published in JAMA earlier this year. Between 25 and 70 percent of prescriptions written for PPIs do not have appropriate medical indications, the study authors write. And with some PPIs available over the counter, their overuse may be even higher.

The first PPI hit the market more than 25 years ago. Manufactured through an agreement with Merck & Co. and Astra AB (now AstraZeneca), Prilosec was approved by the Food and Drug Administration (FDA) in 1989. Now, about seven PPIs are sold today by various pharmaceutical companies, including generic versions of brand name medications like Prilosec.

Since coming on the market more than two decades ago, PPIs have been linked to some serious potential side effects, including an increased risk for bone fractures and heart problems.

More recently, studies have associated PPIs with an increased risk of developing kidney problems, including chronic kidney disease, which could lead to kidney failure and death.

What are PPIs and what do they treat?

Proton pump inhibitors, or PPIs, are a class of drugs used to treat frequent heartburn, gastroesophageal reflux disease (GERD), some ulcers and inflammation of the esophagus.

PPIs reduce the amount of acid in the stomach by blocking the enzyme in the wall of the stomach that produces acid. This, in turn, reduces the amount of acid that can creep up into the esophagus causing heartburn. Frequent heartburn, heartburn occurring two or more times per week, is a symptom of the digestive disorder GERD. Between one quarter and one third of U.S. adults will have GERD symptoms at some point in their lifetime. GERD is most common in adults 50 years of age or older; pregnant women are also especially susceptible to developing GERD.

PPIs are also used to treat ulcers (open sores) in the stomach and small intestine. By reducing the amount of acid, PPIs prevent ulcers from forming and existing ulcers are given a chance to heal.

PPIs reduce acid in the stomach over time and may take days to relieve a person’s symptoms. Antacids like Alka-Seltzer and H2 blockers like Zantac do a better job of providing immediate relief for heartburn.

What are the Brands of PPIs

There are seven different brands of PPIs on the market, each with a different main ingredient. They are manufactured by several different pharmaceutical companies and some are available as generics.

• Prilosec (omeprazole) – approved in 1989; manufactured by AstraZeneca Pharmaceuticals
• Prevacid (lansoprazole) – approved in 1995; manufactured by Takeda Pharmaceuticals USA
• AcipHex (rabeprazole) – approved in 1999; manufactured by Eisai Inc.
• Protonix (pantoprazole) – approved in 2000; manufactured by Wyeth Pharmaceuticals Inc.
• Zegerid (omeprazole and sodium bicarbonate) – approved in 2004; manufactured by Santarus Inc.
• Nexium (esomeprazole) – approved in 2005; manufactured by AstraZeneca Pharmaceuticals
• Dexilant (dexlansoprazole) – approved in 2009; manufactured by Takeda Pharmaceuticals USA

Prilosec, Zegerid and Prevacid are also available over the counter without a prescription. The main ingredients in the over the counter medications are the same as the prescription, but users are directed to only take the over the counter version for about 14 days every four months.

PPIs linked to kidney diseases

Recent studies have indicated an increased risk of kidney disease in patients taking PPIs over a long period of time.

The JAMA study mentioned at the beginning of the article found patients taking PPIs were 20 to 50 percent more likely to develop chronic kidney disease (CKD) than those not taking PPIs. The study also found that patients taking PPIs twice daily were at an even greater risk than those taking PPIs once a day.

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.

The same study also found patients taking PPIs were at a 28 percent greater risk for developing CKD.

The study’s authors concluded patients should only take PPIs when medically necessary and for the shortest time possible.

What is chronic kidney disease?

CKD is the gradual loss of kidney function over time. CKD can lead to kidney failure and death if not diagnosed and treated early. About 26 million Americans suffer from CKD, according to the National Kidney Center.

The kidneys are bean-shaped organs located near the middle of the back below the rib cage. The kidneys filter waste and extra water from the blood and convert it into urine. When the kidneys stop working properly, toxic waste can build up in the blood and cause serious health problems. Severely reduced kidney function can lead to kidney failure and death.

CKD is not always diagnosed right away because the signs and symptoms are subtle and start gradually. Some signs and symptoms of CKD include:

• Changes in urination including urinating more frequently or in greater amounts; urinating less frequently or in smaller amounts; having foamy or bubbly urine or blood in urine; difficulty urinating
• Swelling in legs, feet, face or hands
• Skin rash/itching
• Leg, back or side pain
• Metallic taste in mouth or ammonia breath
• Nausea and vomiting
• Feeling cold
• Shortness of breath
• Dizziness and trouble concentrating
• Fatigue

How do PPIs cause chronic kidney disease?

Researchers have not been able to find a cause-and-effect relationship between PPIs and CKD, though studies show the two may be associated.

Researchers suggest PPIs may cause inflammation in the kidneys which can cause damage over time. Short-term use of PPIs has been linked to an inflammatory condition called acute interstitial nephritis. Repeated bouts of the condition could lead to CKD, say researchers.

PPIs have also been linked to magnesium deficiency in the body, which can cause kidney damage. In 2010, the FDA issued a warning regarding the use of PPIs and the risk for magnesium deficiency.

How do doctors test for chronic kidney disease?

There are three relatively simple tests doctors can use to determine chronic kidney disease in patients. These tests include:

• Blood pressure measurement
• Urine test to measure waste removal
• Blood test to measure waste removal

FDA actions

While the FDA has warned consumers about the other potential adverse side effects of PPIs, like the increased risk for bone fractures, the agency has not yet issued a warning about the possible risk for kidney diseases. This may be because the published studies linking PPIs to CKD and other disease are relatively new.

Proton Pump Inhibitor Lawyers & Attorneys page updated on May 9, 2016