Nexium

  • Nexium

Nexium (esomeprazole magnesium) manufactured by AstraZeneca is a proton pump inhibitor (PPI) approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of peptic ulcer disease, gastroesophageal reflux disease, dyspepsia, and Zollinger-Ellison syndrome. In late 2010, AstraZeneca announced a co-promotion agreement with Daiichi Sankyo to distribute Nexium.

The Journal of the American Medical Association (JAMA) published results of a study related to Nexium intake in their February 2016 issue stating that the risk of chronic kidney disease (CKD) increases by 20 to 50% in patients taking Nexium and similar products.

A 2009 study based in Copenhagen showed that PPI use may cause a rebound acid release if discontinued. This indicates that patients may become dependent on the medications.

In 2006, JAMA published a study which showed that long-term use of PPI medications may increase the risk of hip fractures in the elderly.

Since 2006, PPI medications including Nexium have been the subject of investigations related to harm.

Serious Alleged Injuries may include:

  • Chronic kidney disease (CKD)
  • Nephritis
  • Renal impairment
  • Bone deterioration
  • Dementia/Seizures
  • Tetany(Muscle spasm)
  • Infections
  • Arrhythmia and Heart problems
  • Low magnesium level

FDA SAFETY WARNINGS:

  • In 2010, PPI use was suspected of causing cardiac-related birth defects when taken during pregnancy. The FDA concluded that no statistically significant risk had been shown.
  • In 2010, the FDA issued a consumer warning for bone deterioration with Nexium and other PPI use.
  • In 2011, FDA issued another warning, which said there was a risk of developing low magnesium levels or hypomagnesemia with symptoms of neurological, muscular and cardiac effects on taking PPI, such as Nexium.
  • In 2012, the FDA released a safety communication, stating that the use of Nexium and other PPIs may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD).
  • In December 2014, the FDA issued a warning about adding acute interstitial nephritis to the label, which if left untreated may lead to renal failure.
  • In 2015, the first official warning of PPI related side effects on the kidney was issued by the FDA.
  • In 2016, the study suggested that PPIs, including Nexium, may increase the risk of kidney disease and kidney failure.
  • In October 2016, the FDA required information be added to the label about serious cutaneous and systemic lupus erythematosus events associated with the use of Nexium and other PPIs.

Lawsuit Allegations:

    In August 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) granted the plaintiffs’ second motion for consolidation of Proton Pump Inhibitor (PPI) claims into a multidistrict litigation (MDL) named MDL 2757: IN RE: PROTON-PUMP INHIBITOR. PRODUCTS LIABILITY LITIGATION. The MDL was ordered to be centralized in the U.S. District for New Jersey as more PPI claims were pending in that court than in any other district. The JPML appointed Judge Claire C. Cecchi to preside over the MDL.

    Additional pharmaceutical giants included as defendants in the MDL include: AstraZeneca; Pfizer Inc., (and its subsidiaries Wyeth Pharmaceuticals, Inc., Wyeth, LLC, and Wyeth-Ayerst Laboratories); Procter & Gamble Company; and Novartis Consumer Health, Inc. (and its subsidiaries Novartis Vaccines and Diagnostics, Inc. and Novartis Institute for Biomedical Research, Inc).

    Evidences:

    • Usage of Nexium in Pharmacy records
    • Duration of Usage
    • Indication of Usage in Medical and Pharmacy Records
    • Complications and their treatment after intake

    Medical Record Review and claim validation of Nexium case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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