Proton Pump Inhibitor Claims
Proton Pump Inhibitor Kidney Injury Claims
Heartburn patients allege their long term ingestion of Proton Pump Inhibitors, such as, Nexium, Prilosec, Prevacid, Protonix, Dexilant, or Acidphex caused kidney failure, chronic and acute kidney injuries, or acute interstitial nephritis. Plaintiffs claim taking multiple daily doses of the drugs for over a year may have an increased risk of kidney injuries including:
- Acute Interstitial Nephritis (AIN)
Acute Tubular Necrosis (ATN)
Acute Kidney Injury (AKI)
Acute Kidney Failure (AKF)
- Chronic Renal/Kidney Failure
End Stage Renal Disease (ESRD)
Death – Renal Failure
Other studies suggest a link to:
- Heart Disease
Included are prescription, over the counter (OTC) and generics:
- Nexium (Esomeprazole)
- Prilosec (Omeprazole)
- Prevacid (Lansoprazole)
- Protonix (Pantoprazole)
- Dexilant (Dexlansoprazole)
- Aciphex (Rabeprazole)
Heartburn Kidney Failure Warnings
- Watch the CBS News report here: Heartburn drugs including Prilosec, Nexium, Prevacid linked with …
- A study published in JAMA Internal Medicine in 2016 noted a 20-50 percent increased risk of chronic kidney disease (CKD) associated with proton pump inhibitors such as Nexium. The risk of a decline in kidney function was 32 percent higher for people taking PPIs
- Another clinical study early in 2016 published in the Journal of the American Society of Nephrology (JASN) noted that patients who consume PPIs are more likely to develop kidney failure, with 28 percent of patients more likely to develop chronic kidney disease. Prolonged use only serves to increase those odds.
- In a recent study, the use of PPIs for any period of time, was shown to increase the risk of CKD by 10%. A meta-analysis that was recently published in 2017 indicated that there was a significantly increased risk of CKD associated with use of PPI’s in the absence of intervening acute kidney injury. Currently, the Nexium product labeling does not contain any warning regarding the increased risk of CKD.
Studies Suggest Heartburn Drugs Linked to Heart Disease and Dementia
Studies have linked regular, long-term use of proton pump inhibitors (PPIs) to an increased risk of dementia, cardiovascular disease and renal failure. Medical journal Circulation Research advocate that vascular cells chronically exposed in vitro to PPIs led to a buildup of cellular garbage in cellular linings, thus accelerating blood vessel aging. “I’m perplexed that the pharmaceutical industry didn’t run across this first,” senior study author John P. Cooke, chair of cardiovascular disease research at the Houston Methodist Research Institute, told FoxNews.com. “This is something that should have been apparent a long time ago and should have been investigated.”
Cooke helped author research in 2013 that suggested PPIs decrease nitric oxide in endothelial cells, which line blood cells in the body— an effect that can have an adverse impact on cardiovascular health. He also worked on a 2015 study that linked regular, long-term PPI use to a 20 percent increased risk of heart attack among a database of 3 million patients. “We now have a plausible mechanism that unifies how PPIs are associated with heart attack, vascular dementia and renal failure,” said Cooke, who is also director of the Center for Cardiovascular Regeneration at the Houston Methodist Research Institute.
For his latest study, Cooke and his colleagues exposed endothelial cells over weeks— roughly equal to months or years in a clinical model— to the PPI esomeprazole, or Nexium, as well as another PPI that isn’t commercially available, and to an H2 blocker, another type of medication for GERD. The vascular cells chronically exposed to PPIs had a “fried egg” look, Cooke said. “That was not expected, and then we thought, ‘What could be causing them to age faster if that’s the case?’” he said.
Cooke and his team proved that was the case by using a stain called beta-gal to expose markers for aging. Next, it occurred to them that vascular cells have tiny organelles inside called lysosomes, which act like garbage disposals, or stomachs. It’s well known that if lysosomes are impaired, garbage accumulates and aging accelerates. Researchers found that while the H2 blockers had no effect on vascular aging, chronic use of the PPIs indeed impaired the lysosomes, preventing them from generating acid.
“We also saw the telomeres shortening— they’re on the tips of chromosomes and like our biological clock,” Cooke added. “Those vascular cells couldn’t proliferate or divide as well, and that’s necessary for repairing a wound in the vessel.” Previous research has associated free radical generation and telomere shortening with expedited cell aging. Free radical accumulation in particular can trigger oxidative damage, an effect linked with age-related chronic conditions such as neurodegenerative disorders, like Alzheimer’s disease, as well as cardiovascular disease and cancerNick Leeper, associate professor and chief of vascular medicine at Stanford University, was not involved in the current study but called the new findings “provocative.”
“I think that this is yet another piece of data which all points to a potential risk that should be studied in a prospective, randomized fashion,” Leeper, who worked with Cooke on the 2015 study linking PPIs to an increased heart attack risk, told FoxNews.com. “I think it’s important to note, as the authors point out, that these medicines are frequently used for much longer than the approved indication and are also available over the counter. And so I think that, given this pattern of potential harm that’s been seen in this series of studies described here, that regulators should consider whether additional prospective studies are necessary.”
Cooke said a prospective, randomized trial is the next step for researchers, as the main limitation of his team’s new study is that, although its model is clinically relevant, it was conducted in vitro. However, he thinks his team’s findings warrant action among regulators and doctors. “I’m not saying these drugs should be pulled off the market— they’re safe and effective as approved by the FDA,” Cooke said, “but I do think it’s time to reconsider their use over the counter and re-educate ourselves.”
Nexium (esomeprazole magnesium)
Nexium is manufactured by AstraZeneca as it’s largest-selling drug. In 2008, Nexium sales exceeded $5.2 billion.The lawsuits against Nexium maker, ASTRAZENECA PHARMACEUTICALS LP and ASTRAZENECA LP, allege negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling and/or sale Nexium and/or other Nexium-branded products: Delayed-Release Capsule Pellets and Delayed-Release Oral Suspension Packets.
Science: Proton Pump Inhibitors – PPIs
Proton pump inhibitors (“PPIs”) treat conditions such as:
- Gastroesophageal reflux disease (“GERD”);
- acid peptic disease;
- Zollinger-Ellison syndrome;
- acid reflux; and
- peptic or stomach ulcers.
Nexium works by inhibiting the secretion of stomach acid. It shuts down acid production of the active acid pumps in the stomach thereby reducing hydrochloric acid in the stomach. The drug binds with the proton pump which inhibits the ability of the gastric parietal cell to secrete gastric acid. Hundreds of reports of injury have been submitted to the FDA regarding the ingestion of Nexium and other PPIs. Defendants have received numerous case reports of several types of kidney injuries in patients who ingested Nexium, including: Acute Interstitial Nephritis (“AIN”); Chronic Kidney Disease (“CKD”); Renal/Kidney Failure; and Acute Kidney Injury (“AKI”). However, Astra Zeneca took no action to inform the public or physicians of any risk of kidney injuries.
Acute Interstitial Nephritis – AIN
Acute Interstitial Nephritis (“AIN”) is the inflammation of the tubes and tissues of the kidneys. The most common symptoms of AIN are fatigue, nausea and weakness. Symptoms related to AIN can begin as soon as one week following PPI ingestion. The risk of AIN among PPI users was first raised in 1992. Five years later, an additional study again raised concerns about AIN. Between 2004 and 2007, at least three additional studies confirmed AIN related to PPI usage. More recent studies reveal that those using PPIs such as Nexium are at a three times (3 X) greater risk than the general population to suffer AIN. By July 2011, the World Health Organization adverse drug reaction report included nearly 500 cases of AIN already reported that year, however Defendants still did not warn the physicians or patients, including Plaintiff, of the risks of AIN associated with use of Nexium.
On or about October 30, 2014, the FDA notified Defendants that it had determined that PPIs, including Nexium, pose additional risks not previously disclosed by Defendants.
Chronic Kidney Disease – CKD
Chronic Kidney Disease (“CKD”) is the gradual loss of kidney function. Kidneys filter waste and excess fluid from the blood, which are then excreted. When CKD reaches an advanced stage, dangerous levels of fluid, electrolytes and waste can build up in the body. In the early stages of CKD, patients may have few signs or symptoms. CKD may not become apparent until kidney function is significantly impaired. Treatment for CKD focuses on slowing the progression of kidney damage, usually by attempting to control the underlying cause. CKD can progress to end-stage kidney failure, which can be fatal absent artificial filtering, dialysis or a kidney transplant. Early treatment is often the key to avoiding the most negative outcomes. CKD is associated with a substantially increased risk of death and cardiovascular events. Recent studies have shown the long term use of PPIs was independently associated with a 20% to 50% higher risk of CKD, after adjusting for several potential confounding variables, including demographics, socioeconomic status, clinical measurements, prevalent co-morbidities, and concomitant use of medications.
Acute Kidney Injury – AKI
Recent studies indicate that those using PPIs such as Nexium are at a more than 2.5 times greater risk than the general population to suffer Acute Kidney Injury (“AKI”). Recent studies also indicated that those who develop AIN are at a significant risk of AKI even though they may not obviously exhibit kidney dysfunction. Currently, the Nexium product labeling does not contain any warning regarding the increased risk of AKI.
Safer Alternatives to PPIs
Despite the fact that Nexium and other PPIs lead to an increased risk of numerous injuries, several safer alternatives are available, including but not limited to:
- The use of over-the-counter calcium carbonate remedies tablets that have been available since the 1930s, such as Maalox and Tums; and/or
- The use of histamine H2-receptor antagonists (also known as H2 blockers) that were developed in the late 1960s. H2 blockers act to prevent the production of stomach acid and work more quickly than PPIs and are prescribed for the same indications as PPI’s. Examples of H2 blockers include Zantac, Pepcid and Tagamet. H2 receptor antagonists are not associated with an increased risk of renal injuries.
AstraZeneca knew or should have known about the correlation between the use of Nexium and the significantly increased risks of AIN, CKD, AKI and other renal impairment and failed to adequately warn of these risks from ingestion of Nexium, including the negative effects on the kidney.
By omitting, concealing, and inadequately providing critical safety information regarding the increased risk of kidney injuries with the use of Nexium to the public and healthcare providers, AstraZeneca engaged in, and continue to engage in, conduct likely to mislead consumers and healthcare providers. This conduct is fraudulent, unfair and unlawful and caused plaintiffs to sustain severe and permanent personal injuries, pain, suffering, economic loss, and emotional distress.
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