Vimovo Lawsuit

Were you or a loved one injured by side effects of Vimovo? Get help now.

Update: Study Finds Increased Risk of Death with PPI Heartburn Medications

July 5, 2017 – Proton pump inhibitors have been linked to a 25% greater risk of death compared to patients who took H2 blockers, according to a study published Monday in BMJ. The study also found that PPI use was linked to a 15% increased death rate compared to patients who took another kind of acid suppressor other than H2 blockers, and that the death rate was 23% higher among PPI users compared to people who took no such medications.

What’s the Problem?

The heartburn medication Vimovo has been linked to serious side effects including chronic kidney disease, acute interstitial nephritis, renal failure, bone fractures and more.

What is Vimovo?

Vimovo is a prescription medication that contains esomeprazole and naproxen. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause inflammation, pain and fever. Esomeprazole is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Vimovo was first approved by the U.S. Food & Drug Administration (FDA) on April 30, 2010.

Vimovo Side Effects

Proton pump inhibitors like Vimovo have been linked to the following serious side effects:

  • 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
  • Stroke
  • Bone fractures (hip fracture, wrist fracture, spine fracture)
  • Broken bones
  • Low magnesium levels (hypomagnesemia)
  • Gut infections
  • Clostridium difficile infection
  • Community-acquired pneumonia
  • Dementia
  • Erectile dysfunction (ED)
  • Severe allergic reactions
  • And more

Acute Interstitial Nephritis

Acute interstitial nephritis (AIN), a rare condition that affects the interstitium of the kidneys surrounding the tubules, is an increasingly reported side effect of proton pump inhibitor heartburn medications. Esomeprazole — the active ingredient in Vimovo — was specifically linked to nephritis in a pair of reports published in the Medical Journal of Australia (MJA) in 2005. In both cases, esomeprazole was found to be the “likely causative agent” associated with AIN, with the patients’ symptoms improving upon discontinuation of the drug.

Prior to these reports, Australia’s Adverse Drug Reactions Advisory Committee (ADRAC) had been notified of at least 4 nephritis cases linked to esomeprazole, in addition to 6 cases of acute renal failure and 2 cases of renal impairment. AstraZeneca announced in 2004 that it was aware of at least 15 cases worldwide of AIN potentially linked to the medication, and at least 200 cases worldwide associated with omeprazole (the active ingredient in Prilosec and Losec).

Research published in BMC Nephrology in July 2013 stated that previous studies and numerous case reports have linked the entire class of proton pump inhibitors to acute interstitial nephritis (AIN).

As a result of these problems, in December 2014 the FDA changed Vimovo labels to include a warning about acute interstitial nephritis. The condition can occur at any time during treatment with the drug, according to the agency.

AIN Symptoms

Acute interstitial nephritis can be hard to diagnose because symptoms are often non-specific and can mimic the original indications for which Vimovo was prescribed. When they do present, however, symptoms may include:

  • Blood in the urine
  • Fever
  • Increased or decreased urine output
  • Mental status changes (drowsiness, confusion, coma)
  • Nausea
  • Vomiting
  • Rash
  • Swelling of the body
  • Weight gain

Chronic Kidney Disease

Proton pump inhibitors like Vimovo have been linked to chronic kidney disease (CKD) in the following studies:

  • JAMA Internal Medicine published a study in February 2016 which found that PPI use was associated with a 20-50% increased risk for CKD. The researchers determined that the longer patients use the drugs, the greater their risk of developing the disease.
  • An April 2016 study in the Journal of the American Society of Nephrology (JASN) found that long-term proton pump inhibitor use increased the risk of chronic kidney disease and end-stage renal disease (ESRD) by 28% compared to heartburn medications from the H2 receptor blocker class (Pepcid, Tagamet, Zantac).

What is CKD?

Chronic kidney disease is characterized by the gradual loss of kidney function over time, and includes conditions that damage the kidneys and decrease their ability to perform their usual functions. If the disease progresses, it may eventually lead to end-stage renal disease, which requires dialysis treatment or a kidney transplant to keep the patient alive.

Symptoms

Signs and symptoms of chronic kidney disease may include:

  • Appetite loss
  • General ill feeling and fatigue
  • Headaches
  • Itching (pruritus) and dry skin
  • Nausea
  • Weight loss without trying to lose weight

Heart Attack

PLOS ONE published a study in June 2015 which found that proton pump inhibitors may increase the risk of heart attack by up to 21% compared to H2 blockers, even in individuals with no history of heart problems. “Our results demonstrate that PPIs appear to be associated with elevated risk of {myocardial infarction} MI in the general population,” the researchers said. “And H2 blockers show no such association.”

Bone Fractures

A study in the Journal of the American Medical Association (JAMA) on December 27, 2006, found that long-term PPI use may increase the risk of hip fractures in elderly patients. FDA warned in May 2010 of an increased risk for fractures of the hip, wrist and spine with proton pump inhibitors. Patients at greatest risk were those who used PPIs for 1 year or more, according to the FDA.

Vimovo Timeline

2006 – JAMA study finds increased risk

December 27, 2006 – JAMA study finds that long-term PPI use may increase the risk of hip fractures in elderly patients.

2010 – Approved by the FDA

April 30, 2010 – Vimovo approved by the U.S. Food & Drug Administration (FDA).

2010 – FDA warns of fracture risk

May 25, 2010 – FDA warns of an increased risk of hip, wrist and spine fractures with PPIs.

2013 – BMC Nephrology research published

July 16, 2013 – Research published in BMC Nephrology identifies link between PPI use and acute interstitial nephritis.

2014 – Labeling updated

December 2014 – FDA updates Vimovo labeling to include AIN warning.

2015 – PLOS ONE study findings

June 10, 2015 – Study in PLOS ONE finds up to a 21% increased risk of heart attack associated with PPI use compared to H2 blockers (Pepcid, Tagamet, Zantac).

2016 – JAMA Internal Medicine study published

February 2016 – Study published in JAMA Internal Medicine finds PPI use associated with a 20-50% increased risk for chronic kidney disease (CKD).

2016 – JASN study published

April 14, 2016 – Journal of the American Society of Nephrology (JASN) publishes a study which finds a 28% increased risk for CKD with proton pump inhibitors compared to H2 blockers.

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