Heartburn Med May Cause Kidney Failure. On August 2, the U.S. Judicial Panel on Multidistrict Litigation (JPML) transferred over 160 cases pending against the manufacturers of heartburn medication known as proton pump inhibitors (PPIs). PPI makers are facing allegations in lawsuits involving kidney failure, chronic kidney disease, and other severe renal complications.
The U.S. District Court, District of New Jersey is where pretrial proceedings will take place. Similar lawsuits filed in the future in federal courts will be eligible for transfer to the new multidistrict litigation (MDL). An MDL is often created to consolidate similar complaints to be heard in one court before one judge. This normally results in lessening court costs, allows a faster outcome, and is typically more efficient.
Proton Pump Inhibitor Background
PPIs are used in the treatment of gastroesophageal reflux disease (GERD) also known as acid reflux or heartburn. PPIs work by blocking the enzyme in the stomach wall that makes acid. Popular name brands in this group are Nexium (esomeprazole), Prilosec (omeprazole), and Prevacid (lansoprazole), to name a few.
Over 15 million American were estimated to have used prescription PPIs in 2013. It has, however, been estimated that between 25 percent and 70 percent of these prescriptions do not have proper indication.
Acid blocking medications are among the best-selling drugs in the United States, with more than $10 billion spent annually giving the appearance that “half the country must suffer from acid reflux,” according to CBS2’s Dr. Max Gomez.
National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation, including heartburn medication. Attorneys at the firm are available to answer questions for individuals seeking legal information for a potential lawsuit.
Potential Kidney Damage
Recent studies have suggested that long-term PPI use may be harmful to kidneys. A study published in April 2015 in CMAJ (Canadian Medical Association Journal) Open tied proton pump inhibitors to a three-fold increase in the risk for acute interstitial nephritis, along with a 2.5 times higher risk of acute kidney injury.
Interstitial nephritis is a kidney condition characterized by swelling in between the kidney tubules. The main function of the kidneys is to filter blood and to get rid of waste from the body. Swelling of these tubules may cause a number of kidney symptoms that can be sudden (acute) or chronic.
In January 2016, a study published in JAMA (formerly Journal of American Medical Association) Internal Medicine suggested that PPIs might increase the risk of chronic kidney disease by as much as 50 percent.
A paper published in Journal of the American Society of Nephrology reported in April 2016, that long-term users of proton pump inhibitors may be 96 percent more likely to develop kidney failure and 28 percent more likely to develop chronic kidney disease as opposed to patients using H2-blockers.
H2-blockers target a substance called histamine. The result is that the stomach makes less acid, which cuts down on heartburn. Commonly used H2 blockers are Pepcid (as a prescription) or Pepcid-AC as an over-the-counter (OTC) medication, Tagamet, Axid, and Zantac, are a few of these drugs, according to WebMD.
A study published in Kidney International in February 2017, said that PPI users who go on to develop chronic kidney disease may not suffer any acute renal problems at the beginning, but then many are unaware of the decline in kidney function.
Additionally, a study as recent as February of 2019, conducted by the University of Buffalo indicates that PPI heartburn medication can increase the likelihood of developing chronic kidney disease by 20% and quadruples the chances of kidney failure occurring. In the article, published in the medical journal Pharmacotherapy, a team of four renal experts conducted the first long-term, large sample studies to ever be conducted on PPI heartburn medications. In a sample size of over 190,000 people following a 15-year period, the team discovered that one group experienced an incidence rate of acute kidney injury was nine times more frequent than the control (more than 36 people per 1000) and chronic kidney disease occurrence was almost four times more frequent than the control (more than 34 per 1000). This revolutionary study makes a compelling case for litigation against PPI heartburn manufacturers moving forward.
FDA Label Update
In 2014, the U.S. Food and Drug Administration (FDA) mandated that labels for Nexium and other prescription PPIs be updated to include the potential negative side effect of acute interstitial nephritis. However, the labels have not been changed to reflect any other possible kidney side effects.
Duration of PPI Use and Premature Death
Stomach acid plays an important role in the breakdown and absorption of nutrients. It also kills bacteria and microbes, reports The New York Times. Daily use of acid-suppressing drugs such as PPIs over the long-term may disrupt these processes and make the users more susceptible to nutritional deficits and infections.
A recent study from St. Louis indicated the need for monitoring and limiting the use of PPIs in some cases. “The results suggest excess risk of death among PPI users. Risk is also increased among those without gastrointestinal conditions and with prolonged duration of use. Limiting PPI use and duration to instances where it is medically indicated may be warranted,” according to the study.