Proton Pump Inhibitor Lawsuit

Proton pump inhibitors (PPIs) are medications used to treat Gastroesophageal Reflux Disease (GERD), Peptic Ulcer Disease (PUD) and other stomach conditions but may have been overused. Drug manufacturers are facing thousands of Proton Pump Inhibitor / PPI lawsuits due to serious injuries such as kidney disease, kidney failure and bone fractures.

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Proton Pump Inhibitors such as Prilosec, Nexium and Prevacid may increase the risk of chronic kidney failure. If you or a loved one suffered kidney failure or have been diagnosed with chronic kidney disease after daily use of the prescription strength Prilosec or Nexium, or over the counter Prilosec or Nexium (Brand name only) you may be eligible for compensation. 

Proton Pump Inhibitor Warnings

The February 2016 issue of JAMA, the Journal of the American Medical Association, published results of a study which indicated that long-term use of PPI medications may increase the risk of the development of chronic kidney disease (CKD). The study indicated that the 10-year risk of CKD in PPI users was 20 to 50 percent higher than those who had not taken the medications. The study also showed that the longer a person takes the medications, the greater the risk and patients who took the medications more than once a day were more likely to develop the condition.

In addition to the recently confirmed risk of kidney failure, in June of 2015, the medical journal, PLOS One, reported the results of two studies which showed that PPI use may cause an increased risk of heart attack by as much as 21 percent.

PPI use has been linked to other serious side effects in the past including a 2006 study which showed an increased risk of bone-fractures in the elderly. This study eventually resulted in a 2010 warning issued by the Food and Drug Administration regarding bone fracture risk. In 2009, a study conducted in Copenhagen reported that PPI use may produce a “rebound” acid effect, likening the condition to “dependency” on the medications.

In 2010, investigations were completed regarding a reported increase in risk of cardiac birth defects when PPIs were used during pregnancy. The FDA concluded that there was not a statistically significant link but one PPI (omeprazole or Prilosec) is listed as Pregnancy Category C, indicating that animal studies have shown a potential risk to developing fetuses. Birth defects have been cited as a claim in multiple PPI lawsuits, though no settlements have been reached.

In 2011, a notice was issued by the FDA about PPI-induced hypomagnesemia after long term use of the medications. Low magnesium levels can result in neurological and muscular effects including seizure and effects on the heart. Observational studies have also shown a possible link to other PPI-related serious adverse events including interstitial nephritis, acquired infections and other conditions but more study is needed for confirmation.

No action has been taken yet about the reported link between PPI use and chronic kidney disease, kidney failure or heart attacks by the FDA or PPI manufacturers.

Birth defects, bone fractures, and other serious events have been cited as a claim in multiple PPI lawsuits, though no settlements have been reached.

PPI Use and Chronic Kidney Failure

PPI_INFOGRAPHICThe report in the February 2016 issue of JAMA was the result of an observational study which compared CKD rates of patients who were taking PPI medications over different periods of time. The study involved the examination of medical records of 10,482 patients whose average medical follow-up was 13.9 years. The longer patients had taken PPI medications, the more likely they were to develop chronic kidney disease with an estimated increase risk of 20 to 50 percent. PPI use had already been shown to increase the risk of acute kidney events in patients with prior kidney damage but the recent study excluded patients with pre-existing renal compromise.

Chronic kidney disease, also sometimes called chronic renal failure is caused by repeated damage to the kidneys resulting in an inability to filter metabolic products from the blood.

Over a period of time symptoms may include:

  • Fluid retention
  • High blood pressure
  • Abnormal heart rhythm
  • Electrolyte imbalance
  • Fatigue
  • Itching
  • Fluid in the lungs
  • Heart failure

Symptoms of kidney failure should be reported immediately to a physician.

Researchers conducting the study stated that physicians should be urged to recommend alternatives to PPI medications but also noted that many patients are taking the medications without a clear reason. Many patients may have been taking the medications symptomatically or for issues that have resolved. Over-the-counter availability has likely compounded the problem.

Prior lawsuits against drug companies have claimed that the manufacturers:

  • Made a dangerous or defective drug
  • Did not adequately warn about risks of using the drug
  • Improperly or illegally marketed the medication
  • Knew dangers of medication use and sold the drug anyway

Many defective drug lawsuits are successful and result in judgements or settlements in favor of the plaintiff, however some do not. A lawsuit is no guarantee of compensation and each case must be evaluated separately.

If you or a loved one developed chronic kidney disease, suffered kidney failure or other serious medical injury such as heart attack after using a PPI medication, you should seek legal advice.

About Proton Pump Inhibitors

Proton Pump Inhibitors work by blocking acid release into the stomach. They are used to treat gastroesophageal reflux disease (GERD) which may occur in up to 60 percent of the adult population each year. They are also used to treat peptic ulcer disease (PUD) and a number of other stomach conditions such as “heartburn”.

The PPI market is said to be worth upwards of $10 billion annually in the U.S. alone and Nexium (esomeprazole) was the best selling prescription medication in 2012 and number two on the same list in 2013 with annual revenue of nearly $6 billion.

Up to 14 percent of U.S. adults have received prescription PPI medications and all three of the most popular PPIs are now available over-the-counter. Some estimates show that at least 25% of long-term PPI users could discontinue the medications with no adverse events and that many had started taking them with no clear indication.

Other Side Effects of Proton Pump Inhibitors

PPIs, like all medications, cause a number of side effects, most of which are mild to moderate. Unfortunately, they may also cause serious effects, some of which may be life-threatening.

Common Side Effects of PPIs include:

  • Dizziness
  • Headache, joint aches, muscle pain
  • Stomach complaints such as pain, nausea and diarrhea
  • Unpleasant aftertaste
  • Rash or other skin disruption
  • Anxiety

Serious side effects may include:

  • Severe skin rash (Erythema Multiforme)
  • Low Magnesium level
    • Muscle Spasm
    • Seizures
    • Arrhythmia
  • Osteoporosis
  • Hematologic laboratory abnormalities
  • Birth Defects
  • Speech disorder
  • Liver toxicity
  • Cardiac effects
  • Kidney effects

Serious side effects should be reported to a medical practitioner immediately.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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