What is Nexium?
Nexium (generic: esomeprazole) is a proton pump inhibitor (PPI) heartburn medication that decreases the amount of acid produced in the stomach. The drug is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Pfizer acquired exclusive global rights to Nexium from AstraZeneca in 2012; the medication was first approved by the U.S. Food & Drug Administration (FDA) in 1989.
How Do Proton Pump Inhibitors Work?
PPIs reduce the production of acid by blocking an enzyme in the wall of the stomach that produces acid. Acid is necessary for the formation of ulcers in the esophagus, stomach and duodenum, and the reduction of acid with proton pump inhibitors prevents ulcers and allows any ulcers that exist in the esophagus, stomach, and duodenum to heal.
Which Drugs are PPIs?
In addition to Nexium, other heartburn medications in the proton pump inhibitor class include:
- Aciphex (rabeprazole)
- Protonix (pantoprazole)
- Prevacid (lansoprazole)
- Zegerid (omeprazole / sodium bicarbonate)
- Dexilant (dexlansoprazole)
- Prilosec (omeprazole)
- Vimovo (esomeprazole and naproxen)
What’s the Problem?
Long-term use of Nexium or other PPIs may cause problems with the body’s ability to absorb calcium, magnesium and other vital nutrients. Patients who use these medications for an extended period of time (typically over one year) are at risk of suffering kidney damage, bone fractures / breaks and other serious side effects.
What Side Effects has Nexium Been Linked To?
Nexium has 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
- Bone fractures (hip fracture, wrist fracture, spine fracture)
- Broken bones
- Low magnesium levels (hypomagnesemia)
- Gut infections
- Clostridium difficile infection
- Community-acquired pneumonia
- Erectile dysfunction (ED)
- Severe allergic reactions
- And more
What is Chronic Kidney Disease and How is it Linked to Nexium?
Recent studies have identified a correlation between the use of proton pump inhibitors like Nexium and an increased risk for chronic kidney disease (CKD), a condition that has many stages with health effects ranging from general fatigue to full-blown kidney failure (end-stage renal disease or ERSD). There could be up to a 50% increase in risks for CKD for patients who take Nexium or other PPI.
What are the Symptoms of CKD?
Signs and symptoms of chronic kidney disease include:
- Reduced appetite
- Difficulty concentrating
- Muscle cramps
- Swollen feet
- Swollen ankles
- Dry skin
- Flaky skin
- Frequent urination, especially at night
Has the FDA Issued a Warning on Nexium?
In May 2010, FDA issued a Drug Safety Communication stating that it had updated the labeling of Nexium and other PPIs to include a warning about an increased risk of hip, wrist and spine fractures associated with their use. The label changes were based on FDA’s review of several epidemiological studies that reported an increased fracture rate among PPI users.
“Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors,” the agency said. “The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more).”
Then in December 2014, FDA again announced that Nexium labels would be changed, this time to warn of an increased risk of acute interstitial nephritis (AIN).
“Acute interstitial nephritis has been observed in patients taking PPIs including Nexium,” FDA said. “Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to idiopathic hypersensitivity reaction. Discontinue Nexium if acute interstitial nephritis develops.”
What is Acute Interstitial Nephritis?
AIN is a form of kidney damage that occurs when there is excessive swelling between the kidney tubules. Swelling of these tubules can cause a number of mild to severe symptoms including fever, blood in the urine, increased or decreased urine output, nausea, vomiting, rash and weight gain.
If Nexium is Causing my Kidney Damage, Who is at Fault?
While the investigation into the link between Nexium and kidney damage is still in its early stages, big questions will need to be asked to determine who might have known about these risks and why the public and medical communities weren’t warned sooner. This could mean that the manufacturers may be at least partially responsible. Additionally, if doctors prescribed or recommended Nexium even when a patient wasn’t experiencing symptoms specified by the FDA, they may also bear some responsibility. Our attorneys will investigate your specific case to determine who is liable for your damages.
I Need Nexium to Maintain My Health. What Should I Do if I’m Concerned About the Health Risks?
You should have your kidneys monitored frequently if you must use Nexium to maintain your health. A nephrologist (doctor who specializes in kidneys) may be able to offer you a thorough examination of your kidneys to determine whether you are at an increased risk for injury. You may also want to talk to your doctor about switching to a drug with less severe side effects. However, you should never switch or quit taking a medication without consulting your physician first.
What are Nexium Lawsuits Alleging?
Previous lawsuits filed over injuries allegedly caused by Nexium have alleged that the manufacturer:
- Produced a dangerous and/or defective medication
- Failed to adequately warn of the drug’s risks
- Knowingly hid dangers of Nexium from the public and medical communities
- Marketed Nexium in an illegal or improper manner
Have There Been Any Settlements?
AstraZeneca reached a $20 million class action settlement after it was charged with using deceptive marketing practices to promote Nexium. The company has also settled a number of multi-million dollar price-fixing lawsuits for overcharging Medicare and Medicaid programs for Nexium in Arizona, Alabama, Kentucky, and Massachusetts. Additionally, AstraZeneca may also be facing billions in criminal penalties for illegally paying a generics manufacturer to delay production so that the cost of Nexium would remain high.