How Safe Are Ppis
Ever since omeprazole was marketed in 1989, first as Losec and then as Prilosec, this drug and its chemical cousins have been considered extremely safe by health professionals. Gradually, though, reports of complications started accumulating. We began hearing that PPIs could deplete the body of magnesium and possibly make it harder to absorb calcium from the diet. Then there were warnings about weakened bones and fractures, intestinal infections with C. diff, pneumonia and cardiovascular complications.
Kidney Disease Connected With Protonix Misuse
Sadly, people using Protonix usually will not get a sign that their kidneys are not functioning correctly. The damage caused cannot be undone. People with no kidney problems will not suspect that something is going wrong until its too late.
Protonix prevents the stomach from producing the acid necessary for breaking down food and absorbing minerals, like magnesium and calcium. Evidence shows that long term mistreatment with this drug can lead to kidney deficiency.
A kidney condition called interstitial nephritis often has no symptoms at all, and if left untreated, it can lead to chronic kidney disease. This condition occurs when the kidneys become inflamed due to a lack of minerals in the body.
Furthermore, Protonix is also connected to chronic kidney disease, progressing to kidney failure. End-stage renal disease is when kidneys are no longer able to filter the blood. Unless the patient is placed on dialysis or has a kidney transplant, the result is death.
What Is The Evidence Linking Ppis And Kidney Damage
Over the past few years, several studies have confirmed that chronic PPI users may face an increased risk of developing kidney damage.
A massive study published in 2018 found that long-term users of PPIs face an increased risk of developing acute kidney injury and chronic kidney disease . A follow-up study found that PPI users were 22% more likely to develop kidney injuries or kidney disease than patients taking H2 blockers.
Several recent studies have also found that these heartburn drugs can lead to a condition known as acute interstitial nephritis , which causes swelling inside of the kidneys. Although patients can be treated without permanent damage to their kidneys if the condition is caught early, AIN can cause serious health problems and permanent kidney damage if left untreated.
In 2014, the Food and Drug Administration required the manufacturers of PPIs like Nexium, Prevacid, and Prilosec to add a warning about the risk of AIN and other kidney problems linked to these medications. Although the agency warned that AIN could develop at any point during PPI therapy, the FDA did not add a black box warning or issue a recall notices as a result of the risk of kidney damage associated with PPIs
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Nexium & Prilosec Lawsuit Settlement Amounts
As of this time, there have been no large mass tort settlements involving Nexium or Prilosec and the potential link to kidney injuries. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
We are one of the few law firms that have been appointed to the Plaintiff’s Executive Committee by the judge overseeing all of the federal lawsuits involving Nexium and Prilosec, and its link to kidney and renal injuries. This means that we are directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this drug.
In 2016, AstraZeneca paid the United States Department of Justice a $7.9 million penalty for engaging in a kickback scheme involving the sale of Nexium and Prilosec.
In 2015, AstraZeneca settled a national class action involving deceptive marketing of Nexium for the sum of $20 million.
In 2003, AstraZeneca faced allegations by the European Commission that the company provided false and misleading information in order to protect its patent on Losec . After a two-year investigation, the Commission ordered AstraZeneca to pay a fine of 53 million .
Do I Qualify To File A Lawsuit
If you or a loved one used PPIs like Prevacid, Prilosec, Protonix, or Nexium and were diagnosed with kidney failure or kidney disease, you may qualify to take legal action. The first step in filing a PPI lawsuit is to speak with an experienced pharmaceutical liability attorney, who can advise you regarding your legal rights.
For more information about filing a PPI claim and to find out whether you may be eligible to take legal action, contact the law firm of Hissey Mulderig & Friend for a free legal consultation. You can reach us by calling our attorneys toll-free at , or by filling out the free case evaluation form on the right side of this page.
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What Form Does This Medication Come In
Act-Pantoprazole is no longer being manufactured for sale in Canada. For brands that may still be available, search under pantoprazole. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.
Are Ppis Messing Up Your Kidney Function
Gastroenterologists and drug companies love proton pump inhibitors . These drugs help calm heartburn, reduce irritation from reflux and heal ulcers. So much money has been made from drugs like dexlansoprazole , esomeprazole , lansoprazole , omeprazole , pantoprazole and rabeprazole that it boggles the mind. At last count , 15 million Americans were taking a PPI annually at a cost of at least $10 billion.
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What Should I Know About Pantoprazole Vs Omeprazole And Famotidine
If you have questions about how pantoprazole compares with omeprazole or famotidine, talk with your doctor or pharmacist. They can recommend the type of drug thats right for your condition.
Does Pantoprazole Treat Gastritis Or Ulcers
Gastritis is a condition that causes the lining of your stomach to swell. Ulcers are painful sores on the lining of your stomach. Both of these conditions can lead to symptoms such as nausea, vomiting, and indigestion.
Gastritis and ulcers are sometimes caused by certain drugs or bacteria. Pantoprazole may be used to treat or help prevent gastritis and ulcers in these situations.
If youre interested in using pantoprazole for gastritis or ulcers, talk with your doctor.
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Case 1 Acute Liver Injury Due To Pantoprazole
. Dtsch Med Wochenschr 2003 128: 611-4. German. PubMed Citation]
A 46 year old woman with symptoms of gastroesophageal reflux developed epigastic pain 8 days after starting pantoprazole. She denied jaundice, dark urine, fever, rash or poor appetite. She had no history of liver disease, jaundice, alcohol abuse or risk factors for viral hepatitis. She took no other medications. Her serum aminotransferase levels had been normal 3 days previously when she underwent a routine upper endoscopy under midazolam anesthesia . On examination, she had no fever, jaundice, rash, hepatomegaly or tenderness. Laboratory tests showed moderate elevations in serum aminotransferase levels and bilirubin of 1.0 mg/dL . The alkaline phosphatase levels were normal, but lactic dehydrogenase was slightly elevated . The white blood cell count was normal without eosinophilia. Tests for hepatitis A, B and C and for autoantibodies were negative. An ultrasound showed a gallstone without evidence of biliary obstruction. Pantoprazole was stopped. Serum bilirubin and levels rose for a day and then began to fall and were near normal one week later. A liver biopsy was not done and she was not reexposed to pantoprazole or other proton pump inhibitors.
* Values estimated from Figure 1.
Medications That Can Harm The Kidneys
No matter what kind of medicine you take, whether OTC or prescription, it is destined to take a trip through your kidneys. Taking a drug the wrong way or in excessive amounts can damage these vital, bean-shaped organs and lead to serious complications. In the worst-case scenario, it could necessitate a kidney transplant.
Compared with 30 years ago, patients todayhave a higher incidence of diabetes and cardiovascular disease, take multiple medications, and are exposed to more diagnostic and therapeutic procedures with the potential to harm kidney function, according to Cynthia A. Naughton, PharmD, senior associate dean and associate professor in the department of pharmacy practice at North Dakota State University. All of these factors are associated with an elevated risk of kidney damage.
An estimated 20% of cases of acute kidney failure are due to medications. The technical term for this scenario is nephrotoxicity, which is growing more common as the aging population grows, along with rates of various diseases.
The kidneys get rid of waste and extra fluid in the body by filtering the blood to produce urine. They also keep electrolyte levels balanced and make hormones that influence blood pressure, bone strength and the production of red blood cells. When something interferes with the kidneys, they cant do their job, so these functions can slow down or stop altogether.
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Nexium Bone Injury Mdl Ends In Favor Of Astrazeneca And Mckesson Corporations
In December 2012, the U.S. Judicial Panel on Multidistrict Litigation created an MDL in the Central District of California to merge Nexium bone-injury lawsuits representing more than 1,000 plaintiffs.
But in October 2014, U.S. District Judge Dale S. Fischer granted a defense motion to exclude plaintiffs general causation expert and granted summary judgment. The court said it questioned the reliability of the expert testimony and said without it, the plaintiffs could not establish their cases.
The court then entered judgment in favor of defendants AstraZeneca and McKesson Corporations and against all plaintiffs. In its order, the court said the plaintiffs shall recover nothing and the defendants shall recover their costs of suit.
The federal plaintiffs appealed the judgment, and the Ninth Circuit affirmed the dismissal of about 270 claims. About 40 plaintiffs who asserted Nexium caused bone injury appealed the dismissal of their claims to Californias Second District Court of Appeal, which also affirmed the district courts judgment.
The consolidated action, known as MDL-2404 IN RE: Nexium Products Liability Litigation, officially closed on Jan. 4, 2017, according to the U.S. Judicial Panel on Multidistrict Litigation website.
Timeline of Nexium Bone Fracture Lawsuits
What Is The Link Between Ppis And Kidney Failure
In some cases, the kidney damage caused by PPIs can be very serious. In 2019, researchers at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences published a study which found that PPI users were 20% more likely to develop chronic kidney disease and four times more likely to develop acute kidney injury than non-users.
If left untreated, these problems can lead to kidney failure in some patients. Kidney failure occurs when the kidneys can no longer effectively remove waste products from the body. Patients who develop kidney failure may need dialysis or a kidney transplant in order to keep them alive.
Even more troubling is the fact that many of these patients show no signs of kidney problems before the onset of renal failure. According to a 2017 study by scientists at the Washington University School of Medicine, the kidney problems caused by PPIs can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure. The study found that more than 50% of PPI users who developed kidney failure or chronic kidney disease showed no symptoms before they were diagnosed.
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Astrazeneca Pays More Than $34 Million To Resolve Nexium Allegations
In 2015, AstraZeneca said it would pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government claimed AstraZeneca worked with another company to boost sales.
Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs, Joyce R. Branda, the Acting Assistant Attorney General, said at the time.
The federal government alleged AstraZeneca agreed to pay pharmacy-benefit manager Medco Health Solutions in exchange for Medco maintaining Nexiums sole and exclusive status on certain Medco lists that give details of medicines that may be prescribed. The government further alleged that AstraZeneca provided some or all of the payment to Medco through price concessions on drugs including Prilosec, Toprol XL and Plendil.
Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs. Joyce R. Branda, Acting Assistant Attorney General, Feb. 11, 2015
In addition to kickbacks, AstraZeneca is accused of participating in a pay-for-delay scheme, which is when a pharmaceutical company pays another drug manufacturer to hold off on selling a generic version of a particular drug.
New Data: Ppis And Kidney Function:
The prediction that health professionals could be facing catastrophic consequences if they ignored the early case reports appears to be coming true. Earlier reports that PPIs might affect kidney function have been reinforced by a new study from the Department of Veterans Affairs .
Scientists reviewed the medical records of hundreds of thousands of patients in the VA system. There were 20,270 individuals who had recently been prescribed a drug such as esomeprazole or omeprazole , and 173,321 who were taking a different type of heartburn medicine such as ranitidine or cimetidine .
None of the patients had kidney function problems at the start of the study, but after five years the investigators found that those on PPIs were 28 percent more likely to have developed chronic kidney disease. They were also 96 percent more likely to experience end-stage renal disease, although the total number of people having that extreme outcome was quite small.
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Kidney Injury Lawsuits Consolidated
In October 2016, PPI users who filed six lawsuits against the drugs manufacturers asked a federal judicial panel to consolidate all federal kidney injury cases into a single multidistrict litigation.
At the time, 15 cases asserting similar claims were pending in 12 district courts. By February 2017, the number of related federal lawsuits had more than doubled, reaching 39. Complainants alleged they suffered and continue to suffer from kidney injuries including but not limited to, acute interstitial nephritis, chronic kidney disease or renal failure known as end-stage renal disease, and acute kidney injuries, according to the motion.
They further alleged that AstraZeneca, Takeda and Pfizer, along with others involved in the manufacturing of the drugs, failed to adequately warn about the risk of kidney injuries related to the use of Prilosec, Nexium, Prevacid and other PPIs.
Given the widespread use of PPIs and their defective nature, it is likely that additional claimants will be harmed by the medications and additional similar actions will be filed in or removed to federal courts in the future, Paul J. Pennock, Esq., of Weitz & Luxenberg, P.C., said in the plaintiffs motion.
The panel also took issue with the variety of kidney injuries alleged and the differences among the drugs, including the different U.S. Food and Drug Administration approval times and the fact some are available over-the-counter while others require a prescription.
Important Information About All Medicines
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
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How Does This Medication Work What Will It Do For Me
Pantoprazole belongs to the family of medications called proton pump inhibitors . Proton pump inhibitors are used to treat conditions such as stomach ulcers, intestinal ulcers, and gastroesophageal reflux disease by reducing the amount of acid the stomach produces. Pantoprazole is also sometimes used along with antibiotics to treat stomach ulcers that are caused by bacteria known as H. pylori.
Pantoprazole can also be used to treat or reduce the risk of stomach ulcers due to medications known as nonsteroidal anti-inflammatory drugs , which irritate the stomach.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.