Nexium Lawsuit: Kidney Injury

4D Kidney ModelBasis of the Nexium Lawsuit

The Prilosec & Nexium lawsuit is against the drug manufacturer for failure to warn about the risk of kidney failure. The lawsuits allege that the manufacturer failed to warn both the patients and doctors of kidney risk. Prilosec and Nexium lawyers argue that patients would have chosen alternative medications if warnings were provided. The Nexium attorneys also argue that physicians would have monitored their patients kidneys closer while taking the medication. Prilosec and Nexium are proton pump inhibitors (PPIs), which treat acid-related stomach issues. There are many other drug classes that effectively treat acid-related stomach problems. The first Nexium lawsuit filed was in the U.S. District Court for the Southern District of Illinois. Nexium and Prilosec lawsuits could number in the thousands within a few years.

Nexium Uses

Nexium inside stomachPrilosec and Nexium are primarily for the treatment of acid reflux.  Examples of common acid reflux related conditions treated by Prilosec and Nexium include:

  • Damage to the lining of the esophagus
  • Stomach, gastric or peptic ulcers
  • Stomach infections
  • Gastroesophageal reflux disease (GERD)
  • Heartburn
  • Acid indigestion

 

Widespread Nexium and Prilosec Use

Nexium 24hr opened upOver 15 million Americans are prescribed proton pump inhibitors like Prilosec and Nexium for the treatment of acid reflux. Nexium ranked as the fourth most prescribed drug in the United States from April 2014 through March 2015. Nexium alone sold 15,298,228 prescriptions during the time period. It is important to note that the sales figures do not consider over the counter or generic purchases of Nexium. Overall, the most prescribed drug class in the world are proton pump inhibitors. Physicians have frequently prescribed proton pump inhibitors because they believed they carried a low risk of toxicity. Unknown to the physicians, proton pump inhibitors such as Nexium carry a high risk of kidney injuries.

Between 25% and 75% of patients are unnecessarily taking proton pump inhibitors. Prilosec and Nexium are to be utilized as short-term (2 to 8 week) treatment options for acid reflux. However, many patients have taken various proton pump inhibitors for over a decade without a break. The pharmaceutical companies who produce Prilosec and Nexium make significantly more money when patients continually buy their drug. Proton pump inhibitor sales total $13 billion every year. In 2014, Nexium made nearly $1 billion in a single quarter. Even after recent studies linked Nexium to kidney problems, the pharmaceutical company continues to heavily market the drug.

Out of Control Marketing of Nexium and Prilosec

AstraZeneca, the manufacturer of Nexium, spent $7.3 billion marketing its various drug in 2014. During the same time frame, AstraZeneca only spent $4.3 billion on research and development of its drugs. The manufacturer of Prilosec recently hired Larry the Cable Guy for their commercials. Forbes reported that  “a lucrative deal shilling for Prilosec helped [Larry the Cable Guy] earn $18 million between May 2011 and May 2012.” It is unknown how much additional money Larry the Cable Guy received for his Prilosec endorsements since 2012. What we do know is that Larry the Cable Guy has never warned of the significant risk of kidney injuries.

The marketing for Nexium and Prilosec have paid off for the pharmaceutical companies. The first generic proton pump inhibitor (omeprazole) came to market in 2002. Generic drugs are considerably cheaper than name brand drugs such as Nexium or Prilosec. However, physicians prescribed name brand proton pump inhibitors at twice the rate during the first five years the generic was on the market. Nexium and Prilosec are even available over-the-counter now; therefore, no prescription needed. In 2012, Pfizer acquired the exclusive global rights from AstraZeneca to market over-the-counter Nexium. Regardless of the generics or the over-the-counter availability, Nexium continues to make massive profits. The pharmaceutical companies have learned that consumers will ask their doctors for name brand medications they see on TV.

Nexium and Prilosec TV AdvertisementsLarry the Cable Guy jumps through a ring of fire on a jet ski

The United States is one of the only countries in the world that allows pharmaceutical companies to advertise on television. Pharmaceutical direct-to-consumer advertising has been legal in the USA since 1985. In 1997 the FDA loosened the requirements obliging pharmaceutical companies to include a detailed list of side-effects with their promotions. Since that time, pharmaceutical companies have taken over the airwaves in the United States. As a result of the under regulated advertising guidelines for pharmaceutical companies, thousands of citizens have been injured by Nexium and Prilosec. The advertisements continue though, even as the Prilosec and Nexium lawsuit moves forward.

Nexium Side Effects

Human kidneyBoth short and long-term use of Nexium and Prilosec carry the risk of life-threatening side-effects. Short-term use of Nexium or Prilosec can result in acute interstitial nephritis (AIN). Physicians frequently misdiagnosis acute interstitial nephritis as an acute kidney injury (AKI). Severe reactions to Nexium and Prilosec can result in acute kidney (renal) failure. Kidney failure can result in death. Undiagnosed and repeat incidents of acute interstitial nephritis can result in the development of chronic kidney disease (CKD). To confirm a diagnosis of acute interstitial nephritis, a biopsy of the kidney is needed. Many physicians don’t suspect the possibility of acute interstitial nephritis, because the pharmaceutical companies never warned of the risk. Failure to warn is one of the many causes of action in the Prilosec and Nexium lawsuit.

Recent studies have shown that long-term use of Prilosec and Nexium increases the risk of chronic kidney disease. Nexium and Prilosec increase the risk of chronic kidney disease by approximately 50 percent. Dialysis is required if a patient’s chronic kidney disease progresses to stage 4. Long-term use of Prilosec and Nexium also increases the risk of bone fractures and heart attacks. Those with chronic kidney disease who take Prilosec or Nexium are at the highest risk of complications. Anyone with impaired kidney function that is taking Nexium or Prilosec should speak to their doctor immediately.

Severe Side Effects of Nexium and PrilosecNexium Bottle

  • Acute Interstitial Nephritis
  • Acute Kidney Injury
  • Chronic Kidney Disease
  • Kidney (renal) Failure
  • Heart Attack
  • Osteoporosis (Bone Fractures)
  • Dementia
  • Clostridium difficile infection (C. diff.)

Less Severe Side Effects of Nexium and Prilosec

  • Hypomagnesemia (Low Magnesium)
  • Chronic Inflammation of the Stomach
  • Diarrhea (and also Constipation)
  • Nausea
  • Headache
  • Dry Mouth
  • Drowsiness (Tired)

FDA Action Regarding Nexium and Prilosec

The FDA has not taken any action against Nexium or Prilosec, even though lawsuits are mounting. Both the FDA and the pharmaceutical companies have declined to issue a recall or warning letter. Both manufacturers of Nexium and Prilosec have refused to update their warning letters. The most recent activity at the FDA related to Nexium was on January 26, 2015, when the FDA approved the generic version of Nexium (esomeprazole). Nexium and Prilosec are both high-risk drugs that are currently available over-the-counter. The Prilosec and Nexium lawsuit will progress with or without FDA action.

Alert the FDA if You Have Suffered an Injury from Nexium or Prilosec

If you’ve suffered an injury from taking Nexium or Prilosec, you can alert the FDA through a MedWatch Report. For years physicians have not reported Nexium adverse events to the FDA, because they didn’t know of the possible association. It is unlikely that physicians will retroactively report adverse events to the FDA. Even now that physicians have learned of the association between Nexium and kidney problems, it is unlikely they will report adverse events to the FDA. Submitting an adverse event to the FDA is time consuming and physicians don’t receive reimbursement for submitting a report.

Additional Ways to Alert the FDA if You Have Suffered an Injury from Nexium or Prilosec

A Prilosec or Nexium lawsuit is an additional way to alert the FDA of an adverse event. A pharmaceutical company must notify the FDA every time it receives notice of a lawsuit against one of its drugs. A Prilosec or Nexium lawsuit is a great way to get the FDA and pharmaceutical company’s attention. Lawsuits have a direct impact on the financial books and investor relations with pharmaceutical companies. Unfortunately, pharmaceutical companies have proven that the only thing that effects their actions is money. Call the Hollis Law Firm at 1-800-701-3672 for a free Prilosec or Nexium lawsuit evaluation.

Phamaceutical Companies Involved with Nexium and Prilosec

Manufactured by AstraZeneca

  • AstraZeneca produces both Nexium and Prilosec.
  • Headquartered in London, United Kingdom.
  • Seventh-largest pharmaceutical company in the world.
  • Founded in 1999 through the merger of Astra AB and the Zeneca Group.
  • Employs over 50,000 people.
  • Facilities in the United States, United Kingdom, Sweden, France, Canada, India, China, Brazil and Japan.
  • Most commercially successful medication: Nexium (esomeprazole).
  • 2015 revenue: US$24.708 billion.
  • Named defendant in the Prilosec and Nexium lawsuit.

Marketed over-the-counter by Pfizer

  • Pfizer acquired exclusive global rights to market Nexium over-the-counter for $250 million in 2012.
  • Headquartered in New York City, New York.
  • Founded in 1849
  • 2015 revenue: US$48.85 billion.

Other Types of Proton Pump Inhibitors

Research began on proton pump inhibitors in the 1980s. There are now many types of proton pump inhibitors other than Nexium and Prilosec. These drugs have different manufacturers than Prilosec and Nexium. The warning labels for these drugs also differ from the warning labels on Prilosec and Nexium. As a result, the following drugs are not part of the Prilosec and Nexium lawsuit.

  • Protonix (pantoprazole)
  • Prevacid (lansoprazole)
  • AcipHex (rabeprazole)
  • Noltec (Ilaprazole)
  • Kapidex and Dexilant (Dexlansoprazole)

Prilosec and Nexium Alternatives

There are many alternatives to Nexium and Prilosec to reduce stomach acid. Prilosec and Nexium have a long onset of action, which means relief is not instantaneous. Drugs such as Nexium and Prilosec reach their full effect after approximately five days of use. Once in full effect, Nexium and Prilosec can inhibit stomach acid production for approximately 24 hours. However, many patients report breakthrough symptoms from increased stomach acid in the middle of the night. Because of its long duration of action and previously believed safety, Nexium and Prilosec have been the drugs of choice for suppressing stomach acid. With the recent discoveries of the severe risk associated with Nexium and Prilosec, patients should consider their alternatives. Prior to Nexium and Prilosec, the following types of drugs were utilized to suppress stomach acid:

Calcium Carbonate Antacids

Tums became the first marketed calcium carbonate antacid in the 1930s. The main advantages of this type of antacid is the rapid onset of action and the cheap cost. Tums are able to neutralize stomach acid in less than 30 minutes. However, the effects only last approximately one hour. As a result, calcium carbonate antacids require frequent dosing if a patient has high stomach acid production throughout the day. Antacids such as Tums contain calcium and have been utilized as a calcium supplement. However, taking too many could result in a serious calcium toxicity. Too much calcium can cause renal failure. Many patients changing from Nexium or Prilosec may already have impaired kidney function. Do not change any of your medications without first consulting your doctor. Common calcium carbonate antacids include:

  • Tums
  • Rolaids

H2 Antagonists (H2 Blockers)

H2 antagonists are a type of antihistamine. Histamine increases stomach acid production. Therefore, certain antihistamines are able to decrease stomach acid production. H2 antagonists came to the market in the 1960s. H2 blockers have a longer onset of action compared to calcium carbonate antacids, but a more rapid onset than Nexium or Prilosec. H2 blockers take approximately 90 minutes to start working. However, H2 blockers last about 9 hours, much longer than calcium carbonate antacids. As a result, H2 antagonist are able to suppress stomach acid throughout the night. Due to its long duration of action, H2 blockers quickly replaced calcium carbonate antacids. Eventually, H2 antagonist became the largest-selling prescription worldwide, until Nexium and Prilosec came along.

  • Zantac (ranitidine)
  • Pepcid (famotidine)
  • Axid (nizatidine)

Scientific Articles on Nexium and Prilosec

Aug 2016: Combination Use of Clopidogrel and Proton Pump Inhibitors Increases Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease: A Meta-Analysis. 

The use of drugs such as Nexium or Prilosec while taking clopidogrel (Plavix) significantly increased the rate of major adverse cardiovascular events.

Jun 2016: Proton Pump Inhibitors Accelerate Endothelial Senescence.

Chronic exposure to Nexium or Prilosec reduces telomere length. A telomere is a structure at the end of a chromosome and is part of your DNA. Telomere shortening can cause aging, chronic disease, and even cancer. The authors believe they may have discovered why proton pump inhibitors increase the risk of cardiovascular, renal, and neurological complications.

Jun 2016: Proton Pump Inhibitors Positively Associated with Osteoporosis in Postmenopausal Women in Germany.

The longer someone took Nexium or Prilosec, the more likely they were to experience osteoporosis. Users of a proton pump inhibitor were 50 – 70 percent more likely to develop osteoporosis.

May 2016: Proton Pump Inhibitors Use and Change in Bone Mineral Density.

Those without risk factors for osteoporosis who took Nexium or Prilosec were more likely to develop osteoporosis than those who did not take the medication.

Apr 2016: Delirium in the geriatric unit: Proton-Pump Inhibitors and Other Risk Factors.

The use of drugs such as Nexium and Prilosec were found to be linked elderly patients becoming confused. The use of proton pump inhibitors among the elderly increased their risk of confusion by nearly 70 percent.

Mar 2016: Effect of Proton Pump Inhibitors on Magnesium Balance: Is there a Link to Cardiovascular Risk?

The study found Nexium and Prilosec to be linked to low magnesium levels and heart complications. Magnesium is one of the most abundant elements inside human cells. Magnesium is necessary for nerves to work properly, muscle contraction, bone formation and enzyme activation. The intestines, bones, and kidneys work closely together to regulate magnesium. Seizures and heart complications are common with magnesium imbalances.

Feb 2016: Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.

Drugs such as Nexium and Prilosec were found to increase the risk of chronic kidney disease by as much as 75 percent.

Aug 2015: Risk of Dementia in the Elderly Patients with the use of Proton Pump Inhibitors.

Over 3,000 community-dwelling persons over 75 years old were studied. Nexium and Prilosec were associated with 38% increased risk of dementia and a 44% increased risk of Alzheimer’s disease. The study was noted as being of high importance due to the major burden of dementia on public health and lack of curative treatment.

May 2015: Continuous Proton Pump Inhibitor Therapy and the Associated Risk of Recurrent Clostridium Difficile Infection.

754 patients who had developed C. Difficile were studied. Use of drugs such as Nexium or Prilosec were found to increase the risk of C. Difficile by 50 percent. C. Difficile is an organism that can results in severe diarrhea. The authors suggest discontinuing proton pump inhibitors if a diagnosis of C. Difficile is made.

Aug 2013: Long-term Proton Pump Inhibitor Use is Associated with Vascular Calcification in Chronic Kidney Disease: A cross-sectional study using propensity score analysis.

387 patients receiving dialysis for over one year were studied. Long term use of drugs such as Nexium and Prilosec increased the risk of vascular calcifications by over 250%. Vascular calcifications are a strong indicator of impending death in patients with chronic kidney disease.

Jan 2008: Overprescribing of Proton Pump Inhibitors.

There is no indication to use Nexium or Prilosec in 25 to 70 percent of those who are taking it. Unnecessary use of Nexium and Prilosec resulted in approximately $2 billion extra health care cost. The study also mentions an increased risk of pneumonia and a doubling in the risk of C. Difficile.

 

Nexium Lawsuit

Please call us to speak to one of our trained team members about the Prilosec and Nexium lawsuit. A Prilosec and Nexium lawyer will look over your case and let you know what they believe the best course of action is for you. Call today at 1-800-701-3672 for a free Prilosec and Nexium lawsuit evaluation. All case reviews are confidential and free of charge. The Hollis Law Firm operates on a contingency fee only basis.

Content created by

C. Brett Vaughn RN, BSN, JD

 

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