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Nexium Lawsuit

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Nexium Lawsuit

More than 60 million Americans suffer from heartburn at least once a month, with an estimated 15 million suffering from heartburn every single day1. That’s why heartburn medications like Nexium have become blockbuster drugs used by millions of people. In fact, Nexium became the second most-prescribed drug in the country in 2010.

Even though Nexium is one of the top sellers in the United States and has brought in billions of dollars for pharmaceutical company AstraZeneca, the drug carries side effects that have put countless users at risk for fractures, infections, kidney troubles, and more.

As a result of these hidden or understated side effects, thousands of people have filed lawsuits against the maker of Nexium over claims that it failed to warn patients and doctors of side effects, made defective drugs, concealed dangers, and more.

What is Nexium Used For?

Nexium — also known as the purple pill — is a medication used to treat different kinds of stomach and esophageal issues. Here are some of the conditions Nexium is used to treat.

Gastroesophageal Reflux Disease (GERD)

Nexium has been approved by the U.S. Food and Drug Administration to relieve heartburn and treat other symptoms associated with GERD. The disease occurs when the muscle at the end of the esophagus does not close properly, causing stomach acid to flow back into the esophagus2. This can cause major discomfort. Other symptoms of GERD include chest pain, a dry cough, the taste of acid in the back of the mouth, asthma, and trouble swallowing. Nexium is prescribed for short-term treatment of GERD for about 4 to 8 weeks.

Erosive Esophagitis

When someone experiences GERD for extended periods of time, the stomach acid can wear away the inner lining of the esophagus. Nexium is indicated to keep symptoms of GERD away and help heal erosive esophagitis. Nexium has been shown to be effective in treating those with severe forms of erosion.

NSAID-Associated Gastric Ulcers

Nexium is also indicated for the reduction of gastric ulcers associated with the use of NSAID therapy. These inflammatory drugs are known to increase the risk of ulcers in those older than 60 or with a history of gastric ulcers.

H. Pylori Eradication & Duodenal Ulcers

Patients with H. pylori infection and a history of duodenal ulcer disease can be given Nexium, along with amoxicillin and clarithromycin, to help eradicate H. pylori.

Zollinger-Ellison Syndrome

Nexium is also indicated for the long-term treatment of pathological hypersecretory conditions. These types of conditions, including Zollinger-Ellison syndrome, make higher amounts of acid in the stomach and can increase a person’s risk for ulcer diseases and GERD.

How Nexium Works

Nexium, which is the brand name for the drug esomeprazole, belongs to a class of drugs called proton-pump inhibitors (PPIs). The medication works by turning off the small pumps in the stomach that make acid. This reduces the amount of acid in the stomach.

Unlike other medications like antacids, Nexium takes longer to work because it does not neutralize the acid already in the stomach. Instead, it simply stops acid from being produced.

Types of Nexium Products

Nexium comes in several types of products, including both over-the-counter and prescription formulas. The original product is simply known as Nexium. It comes in a capsule in a delayed-release formula to keep the medication from being broken down by stomach acid. Tablets can also be put into a glass of water and dissolved or injected into the stomach via a gastric tube3.

Nexium is available in an injectable version called Nexium IV, which is designed to be used when oral therapy cannot be administered. Nexium IV is only given in the hospital by a health care professional. It is also only approved to treat patients 1 month old or greater4.

Finally, Nexium is also available in an over-the-counter version called Nexium 24HR. The medication offers 24-hour protection from heartburn without the need for a prescription. Nexium 24HR is marketed by Pfizer.

Common Nexium Side Effects

Like nearly all medications, Nexium is associated with common yet mild side effects5. These include:

  • Headache
  • Diarrhea
  • Nausea
  • Gas
  • Abdominal Pain
  • Constipation
  • Dry Mouth
  • Drowsiness

Those with other symptoms, such as seizures, dizziness, fast heartbeat, muscle weakness, spasms, and shaking, should contact their doctor immediately.

Risks Associated with Nexium

Since Nexium was first approved for use by the FDA in February 2001, it has been linked to more serious complications that could adversely affect a user.Stomach and/or

Stomach and/or Gastric Cancer

Nexium and other common acid reflux medications have been linked to causing cancer in the stomach and gastrointestinal areas.

Fractures

Users who take Nexium for extended periods of time may be more susceptible to bone fractures of the hip, wrist, and spine. In May 2010, the FDA issued a safety communication warning of a possible increased risk of fractures in PPIs like Nexium6.

The decision to update the labels of all PPIs came about after the agency reviewed seven published epidemiological studies.

In six of the studies, an increased risk of fractures was noted in those who used PPIs. The highest risk came in those who took the drugs for a year or longer. Older people were more likely to suffer fractures. Although the FDA initially planned on revising the label for over-the-counter versions, it decided not to add a fracture warning in March 2011 since small doses for short periods of time did not seem to increase the risk.

Kidney Disease & Injury

Several studies have shown that serious kidney problems, including kidney failure, could be caused by PPIs. In 2015, two studies confirmed a link, even though a cause-and-effect relationship was not proven. However, one of the lead authors indicated PPIs are likely the cause.

“It is very reasonable to assume that PPIs themselves can cause chronic kidney disease,” said Dr. Pradeep Arora, the lead author of one of the studies, told HealthDay at the time7. Although the FDA looked into the connection between PPIs and kidney injuries, the agency decided that no action was necessary based on the available information in 20178.

Other kidney related risks include:

  • Acute kidney failure/renal failure
  • Chronic kidney disease (Stage 3, 4 & 5 only)
  • Kidney failure

Severe Diarrhea

In 2012, the FDA also sent a safety communication warning that PPIs may be associated with an increased risk of Clostridium difficile–associated diarrhea9. C. diff is a type of bacterium that causes diarrhea that does not improve on its own. Symptoms can be watery diarrhea up to 15 times a day accompanied by fever, cramping, nausea, kidney failure, and more.

When left untreated it can cause dehydration, kidney failure, bowel perforation, and even death.

Twenty-three studies showed a higher risk of the infection in those exposed to PPIs than those who weren’t.

Cognitive Decline

Several studies have explored the possibility of cognitive decline in those taking PPIs with mixed results. One 2016 study suggested an association between dementia and PPIs by looking at more than 70,000 patients10.

The study received tons of media attention, but at least three follow-up studies could find no link.

Vitamin B12 Deficiency & Low Magnesium Levels

Long-term treatment with Nexium may lead to malabsorption of vitamin B12. Warnings about vitamin B12 deficiencies were added to the labels of PPIs like Nexium in December.

Low magnesium levels were also noted in those taking Nexium. The FDA sent a warning that Nexium and other PPIs could lead to low levels of circulating magnesium, ultimately increasing the risk of leg spasms, seizures, arrhythmias, and more11.

“Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms,” the FDA said in 201111.

Nexium Lawsuits Filed Over Fractures

As a result of the major side effects associated with Nexium, thousands of people have taken to the legal system to pursue justice against AstraZeneca and Pfizer over claims that the companies hid risks and illegally marketed drugs.

Some of the first lawsuits related to Nexium came in 2011 over claims that Nexium caused fractures. By the next year, more than 40 lawsuits were consolidated into a single federal court by the U.S. Judicial Panel on Multidistrict Litigation (JPML). The litigation over bone fractures grew to more than 1,000 lawsuits against AstraZeneca.

AstraZeneca Settles For Millions in Two Lawsuits

AstraZeneca has faced lawsuits related to its business dealings with Nexium as well. Plaintiffs brought a class-action lawsuit against the company over claims that it paid a company to delay bringing a generic version of Nexium to the market.

Whistleblowers also brought a lawsuit against AstraZeneca under the False Claims Act. It resulted in a $7.9 million settlement with the federal government that resolved allegations that the company engaged in kickback schemes to illegally boost profits.

“The settlement resolves allegations that AstraZeneca agreed to provide remuneration to Medco Health Solutions, a pharmacy benefit manager, in exchange for Medco maintaining Nexium’s ‘sole and exclusive’ status on certain Medco formularies and through other marketing activities related to those Medco formularies,” the Justice Department announced in 201512.

Thousands More File Nexium Kidney Lawsuits

More recently, users of Nexium and other PPIs have filed lawsuits related to kidney disease and injuries. The first Nexium kidney damage lawsuit was filed in 2016. The JPML initially denied a motion to consolidate the growing number of cases into a multidistrict litigation but ultimately granted the request to centralize 161 cases in 2017.

More than 4,200 lawsuits were pending in New Jersey federal court under U.S. District Judge Claire C. Cecchi as of May 201813.

In January 2018, the judge issued a case management order that a “science day” would take place in May 2018. A science day has been increasingly employed in mass tort litigation in order to allow both sides to better educate themselves on the scientific and technical aspects of the case.

Those who have suffered from kidney injuries as a result of taking Nexium are encouraged to contact an experienced attorney to find out whether they have a case against AstraZeneca14.

References

  1. American College of Gastroenterology. “Acid Reflux”, American College of Gastroenterology, http://patients.gi.org/topics/acid-reflux/. Accessed May 26th, 2018.
  2. U.S. National Library of Medicine. “GERD Also called: Gastroesophageal reflux disease”, MedlinePlus, https://medlineplus.gov/gerd.html. Accessed May 26th, 2018.
  3. HPRA. “PACKAGE LEAFLET: INFORMATION FOR THE USER”, Health Products Regulatory Authority, http://www.hpra.ie/img/uploaded/swedocuments/2132016.PPA1463_002_002.20665495-7afe-41f0-9616-5907c0848ce0.000001pil.130711.pdf. Accessed May 26th, 2018.
  4. NEXIUM I.V.. “NEXIUM I.V. is approved for more patients than any other I.V. PPI”, nexiumtouchpoints.com, https://www.nexiumtouchpoints.com/nexium-information/gerd-treatment.html. Accessed May 26th, 2018.
  5. AstraZeneca. “SAFETY INFORMATION”, AstraZeneca, https://www.purplepill.com/heartburn-relief/nexium-side-effects.html. Accessed May 26th, 2018.
  6. FDA. “FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors”, U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/DrugSafety/ucm213206.htm. Accessed May 26th, 2018.
  7. Dennis Thompson. “Heartburn Drugs Tied to Higher Kidney Disease Risk”, WebMD, https://www.webmd.com/heartburn-gerd/news/20151027/chronic-heartburn-drugs-tied-to-higher-risk-of-kidney-disease#1. Accessed May 26th, 2018.
  8. FDA. “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April – June 2017”, U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm579459.htm. Accessed May 26th, 2018.
  9. FDA. “FDA Drug Safety Communication: Clostridium difficile associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)”, U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/DrugSafety/ucm290510.htm. Accessed May 26th, 2018.
  10. Allan S. Brett, MD. “Association Between Proton-Pump Inhibitors and Dementia?”, NEJM Journal Watch, https://www.jwatch.org/na41375/2016/05/19/association-between-proton-pump-inhibitors-and-dementia. Accessed May 26th, 2018.
  11. FDA. “FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)”, U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/DrugSafety/ucm245011.htm. Accessed May 26th, 2018.
  12. Department of Justice. “AstraZeneca to Pay $7.9 Million to Resolve Kickback Allegations”, United States Department of Justice, https://www.justice.gov/opa/pr/astrazeneca-pay-79-million-resolve-kickback-allegations. Accessed May 26th, 2018.
  13. United States Judicial Panel on Multidistrict Litigation Report Date: 5/15/2018. “MDL Statistics Report – Distribution of Pending MDL Dockets by District”, United States Judicial Panel, http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-May-15-2018.pdf. Accessed May 26th, 2018.
  14. David Schwartz and Nathan Schachtman. “How Science Days Are Changing Talc Litigation”, Law360, https://www.law360.com/articles/935225/how-science-days-are-changing-talc-litigation. Accessed May 26th, 2018.
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