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Protonix Drug Lawsuit Source

Protonix Lawsuits: Kidney Complications

Commonly asked questions about Protonix (pantoprazole):

What Is Protonix?

Protonix, a proton-pump inhibitor (PPI), is a drug used to combat the symptoms of frequent heartburn triggered by the accumulation of stomach acid or bile in the esophagus. This is commonly referred to as acid reflux.

The anti-ulcer drug can be administered through two primary methods, delayed-release tablets or delayed-release oral suspension. While tablets are swallowed, the delayed-released oral suspension dosage is administered through disintegration in a consumed portion of apple juice or applesauce.

Developed by Pfizer Inc. subsidiary Wyeth, a New York-based pharmaceutical company, Protonix was initially approved by the U.S. Food and Drug Administration (FDA) in February 2000 for 8-week treatments. Two additional FDA approvals followed the initial approval date with the final approval being announced in April 2002 for long-term treatment to combat health complications, including Zollinger-Ellison Syndrome.

Protonix (pantoprazole) is categorized in the same pharmacoligic class as popular medication Prilosec (omeprazole), sharing a wide range of characteristics with the drug and other PPI medications. The drugs allow the esophagus to heal from exposure to stomach acid by decreasing the amount of acid the stomach produces. With stomach acid withdrawing from the esophagus, ulcers (sores in the lining of the stomach or intestine) and non-steroidal anti-inflammatory drug-induced ulcers can be prevented.

Proton pump inhibitors are the most common category of drug used by victims of acid reflux/heartburn with prescriptions written to over 15 million Americans per year. However, these drugs have been associated with a rising number of health complications.

The popularity of the drug class has led to several notable research teams conducting studies on the effects of the various members of the PPI family. These studies, many published in the last two years, have yielded data heavily suggesting a connection between PPI use, including Protonix, and the development of chronic kidney disease (CKD).

With confirming data continuing to be produced, dangerous drug attorneys are investigating lawsuits against Protonix and other PPI drugs on behalf of former or current patients who were subjected to drug-related health complications.

What Is Gastroesophageal Reflux Disease (GERD)?

GERD is a common occurrence in healthy infants, children, and adults. In most cases the effects quickly subside without causing major pain or other health complications.

There are several conditions that can trigger acid reflux disease with one of the most common being hiatal hernia, a stomach abnormality that effects people of any age.

The most widely reported cause of acid reflux disease is an issue within the lower esophageal sphincter (LES) muscle. This muscle is responsible for separating the stomach and esophagus, closing tightly after food has passed through the stomach. Acting as a “valve” between the two organs, the tightening of the muscle prevents stomach acid from reaching the esophagus.

In people who experience acid reflux disease, the LES is unable to close properly. With the LES unable to tightly close, contents of the stomach, including acid, is able to leak into the esophagus causing an intense burning sensation.

In addition to pain in the upper abdomen and chest, victims often report nausea, acid-like taste in the mouth, bloating, belching and indigestion (dyspepsia) as common symptoms. These symptoms are similar in intensity and duration as heartburn as they tend to come and go with their effects peaking after meals.

What Are Common Acid Reflux Symptoms?

Those who experience acid reflux report a wide variety of associated health complications but all typically do not endure for an extended period of time after initial symptoms surface.

Heartburn Bloating
Bloody or black stools Bloody vomit
Fatigue Dizziness
Burping Dysphagia
Nausea Weight loss
Chronic sore throat Wheezing, hoarseness

 

How Do I Take Protonix?

Protonix can be administered through ingestion of a capsule/tablet or orally disintegrating tablet. These methods are available in dosage amounts of 20 mg and 40 mg. Tablets should not be crushed or chewed and disintegrating tablets should only be combined with applesauce or apple juice. The drug is typically prescribed for use once a day (every 24 hours), everyday for an 8 week period.

8 Week Delayed-Release Tablets

  • Capsules can be taken with or without food
  • Patient must swallow tablets whole
  • 40 mg tablets can be substituted with two 20 mg tablets if a patient is unable to swallow the larger tablet
  • Do not split, chew, or crush a tablet for any reason
  • Consult your doctor for use beyond original 8 week prescription

8 Week Delayed-Release Oral Suspension (Disintegrating Tablets)

  • Prescription should be taken 30 minutes before a meal
  • Tablets can only be combined with applesauce or apple juice
  • No other liquids or foods should come into contact with the prescription, including water
  • Tablet cannot be chewed, crushed, or altered in any fashion
  • Entire dosage packet must be used, do not divide dosage into smaller amounts

Applesauce Directions:

  1. Open packet
  2. Pour contents on one teaspoon of applesauce without crushing or chewing contents
  3. Take within 10 minutes of contents exposure to applesauce
  4. Sip water to ensure drug is washed down to the stomach

Apple Juice Directions:

  1. Open packet
  2. Pour contents into teaspoon of apple juice
  3. Stir mix for 5 seconds and immediately swallow – contents will not dissolve
  4. Rinse container with apple juice and swallow contents until entire dosage is taken – once or twice

Consult with your doctor before taking Protonix if you are taking:

  • Atazanavir or Nelfinavir (Antiretroviral Therapy)
  • Warfarin (Coumarin Anticoagulants)
  • Clopidogrel
  • Methotrexate

What Are The Most Common Protonix Side Effects?

Since gaining FDA approval, independent studies, manufacturer research, and FDA investigations have discovered a multitude of health complications that may be associated with Protonix use, these commonly include:

Headache Nausea
     Diarrhea       Abdominal Pain
Vomiting Flatulence
Dizziness Arthralgia

 

What Are Uncommon Protonix Side Effects?

In addition to common side effects, the FDA has reported several possible side effects associated with Protonix use. These side effects occurred in less than 2% of studied patients but should still be noted by consumers. Some of them include:

Pyrexia          Hepatitis
     Thrombocytopenia           Myalgia
Depression          Vertigo
Rash           Blurred Vision

 

Has Protonix Use Been Linked To Chronic Kidney Disease (CKD)?

With proton pump inhibitors (PPIs) effecting millions of Americans every year, medical experts have conducted extensive studies to determine if PPIs, including Protoxin, are associated with long-term kidney damage.

One of the most recent studies was published in the JAMA Internal Medicine Journal on January 11, 2016 by researchers at Johns Hopkins University in Baltimore.

According to lead author Dr. Morgan Grams, an assistant professor of epidemiology at Johns Hopkins University, proton pump inhibitor users are at a 20-50% higher risk of developing chronic kidney disease than nonusers.

“We found there was an increasing risk associated with an increasing dose,” Gram told HealthDay. “That suggests that perhaps this observed effect is real.”

The study covered 322 PPI users and yielded a 10-year absolute risk estimated for chronic kidney disease of 11.8%.

Proton pump inhibitor drugs have had a known connection to short-term kidney problems, including acute kidney injury and acute interstitial nephritis, for an extended period of time, according to Dr. Gram.

If left untreated, chronic kidney disease can lead to total kidney failure, leaving some patients with no choice but to undergo regular dialysis treatments and in some cases a kidney transplant.

Am I Eligible To Take Legal Action Against Protonix?

Protonix has been linked to serious side effects including chronic kidney disease (CKD), bone fractures, vomiting, and diarrhea.

Pfizer Inc. has faced legal trouble regarding their handling of Protonix in the last decade highlighted by a $55 million settlement to resolve allegations that Wyeth promoted the drug for non-FDA approved uses.

However, that settlement was dwarfed by a second settlement agreed to this year between Pfizer and the federal government. The settlement, in response to allegations that Wyeth knowingly underpaid Protonix rebates between 2001 and 2006, is for a reported $784.6 million.

The settlement will be distributed to the federal government and individual states with nearly $371 million being allocated to the Medicaid program.

Our No-Fee Promise on Protonix Kidney Disease Cases

You can afford to have our great team of Protonix lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a Protonix settlement
  • Phone calls are always free

How Do I Start A Protonix Kidney Disease Claim?

Our Protonix lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-4722 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing Protonix lawsuit claims.

View Sources

  1. Prescribing Information – FDA
  2. Pfizer Settlement – Fox 43 
  3. Heartburn Drugs Linked To Kidney Disease – CBS News

References