What is Protonix?
Protonix (generic: pantoprazole) is a proton pump inhibitor (PPI) medication that decreases the amount of acid produced in the stomach. The drug is used to to treat gastroesophageal reflux disease (GERD) and other conditions involving excess stomach acid such as Zollinger-Ellison syndrome. Protonix is made by Pfizer Inc., and was first approved by the U.S. Food & Drug Administration (FDA) in February 2000.
Which Other Drugs are Proton Pump Inhibitors?
In addition to Protonix, other heartburn medications in the PPI class include:
- Nexium (esomeprazole)
- Aciphex (rabeprazole)
- Prilosec (omeprazole)
- Prevacid (lansoprazole)
- Zegerid (omeprazole / sodium bicarbonate)
- Dexilant (dexlansoprazole)
- Prilosec (omeprazole)
- Vimovo (esomeprazole and naproxen)
What Makes Protonix Different?
While all the above-listed proton pump inhibitors are used to treat similar conditions, Protonix is available by prescription only whereas many of the others are available over-the-counter (OTC). Additionally, Protonix is almost always exclusively prescribed to help heal erosion of the esophagus caused by excess stomach acid and chronic conditions.
What’s the Problem?
Although effective at treating GERD and other stomach acid conditions, proton pump inhibitors like Protonix can cause problems with the body’s ability to absorb calcium, magnesium and other essential nutrients. People who use PPIs for an extended period of time (typically 1 year or more) may have an increased risk of developing kidney damage, heart problems, bone fractures and other adverse health complications.
Has Prilosec Been Linked to Serious Side Effects?
Serious side effects of Protonix may include:
- Acute interstitial nephritis (inflammation of the kidneys)
- Acute kidney injury
- Chronic kidney disease (CKD)
- Kidney failure (end-stage renal disease or ERSD)
- Cardiac disorders
- Heart attack
- Bone fractures (hip fracture, wrist fracture, spine fracture)
- Broken bones
- Low magnesium levels (hypomagnesemia)
- Rebound Acid Hypersecretion (RAHS)
- Gut infections
- Clostridium difficile infection
- Community-acquired pneumonia
- Erectile dysfunction (ED)
- Severe allergic reactions
- And more
Have Studies Been Conducted?
Protonix and other proton pump inhibitors may triple the risk of acute interstitial nephritis (AIN), according to an April 2015 study published in CMAJ Open. Researchers also found a 2.5-fold increased risk of acute kidney injury based on data from 290,000 elderly patients in Canada.
In February 2016, Dr. Morgan Grams of Johns Hopkins University published a study in JAMA Internal Medicine linking twice-daily doses of proton pump inhibitors to a 46% increased risk of chronic kidney disease.
Has the FDA Warned About Protonix Side Effects?
After receiving dozens of case reports, the U.S. Food & Drug Administration (FDA) in December 2013 updated the labeling of Protonix to include a warning about acute interstitial nephritis. The condition is characterized as a sudden kidney inflammation and swelling due to an allergic reaction, and may occur at any time during treatment with the drug, according to the FDA.
Are There Dangerous Drug Interactions?
One of the biggest dangers patients face when taking Protonix is the risk of a severe allergic reaction or drug interactions. The list of medications Protonix interacts with includes (but is not limited to):
- Ampicillin (antibiotic)
- Warfarin, Coumadin (blood thinners)
- Clopidogrel, marketed under the brand name Plavix (cholesterol medication)
- Ketoconazole (antifungal medication)
- Iron supplements
- Atazanavir and Nelfinavir (anti-HIV drugs)
- Digoxin (used to treat congestive heart failure)
- And more
Can I Take Protonix During Pregnancy or While Breastfeeding?
Protonix is a pregnancy class B medication, which means there aren’t enough studies available to show how pregnant women and their unborn fetuses may react to the drug. However, because pantoprazole — the active ingredient in Protonix — can pass through breast milk and may cause adverse effects in infants, it is strongly recommended that nursing mothers discontinue use of the drug or stop nursing while using it.
Has Protonix Been Recalled?
Despite being linked to the above serious side effects, Protonix has not been recalled in the U.S. and continues to be prescribed to millions of unsuspecting patients around the country. However, the investigation into the health risks posed by the drug is still in its early stages and not all the facts have come out which may eventually lead to a recall.
Are Cases Being Settled?
In February 2016, Pfizer announced that it would pay $785 million to settle False Claims Act lawsuits alleging that its Wyeth unit overcharged Medicaid for Protonix. Pfizer said it reached an “agreement in principle” to make the payout in exchange for dismissal of 2 whistleblower suits filed by the U.S. Department of Justice in 2009.
Is There a Class Action?
No class action lawsuit has yet been filed in the Protonix litigation. However, our lawyers are filing individual lawsuits for people who suffered kidney damage after taking the drug. If we determine that you have a valid claim, you may be eligible to receive compensation for medical expenses, lost wages, pain and suffering, and other damages.
Why Our Law Firm is Against Filing Class Action Lawsuits
When pharmaceutical companies fail to warn about side effects and consumers are injured as a result, class action lawsuits can have disadvantages since they are organized for efficiency rather than maximizing compensation, and members may have to accept higher attorneys’ fees or “low-ball” settlements.