Prilosec Lawsuit

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 Prilosec (generic: omeprazole) has been linked to serious side effects including chronic kidney disease, acute interstitial nephritis, kidney failure (end-stage renal disease or “ESRD”), bone fractures, heart attack and more. Patients who suffered kidney damage after taking Prilosec may be able to file a lawsuit seeking compensation for their injuries.

What is Prilosec?

Originally approved as “Losec” in 1989, Prilosec was the first in a new class of heartburn drugs known as proton pump inhibitor (PPIs) that work by blocking the proton pumps from releasing acid into the stomach. In 1990, Losec was changed to Prilosec after the name’s similarity to an antidiuretic drug caused numerous medication errors, at least one of which resulted in the death of a patient.

Prilosec was massively successful and sold at a rate of $6.1 billion in its peak sales year of 2000. A year later, after the drug’s patent protection ran out, Prilosec’s manufacturer AstraZeneca introduced a “next generation” formulation of Prilosec called Nexium (generic: esomeprazole). Prilosec became available as an over-the-counter (OTC) medication in 2003. OTC sales of Prilosec reached almost $400 million in 2013, and it continues to be among the top 5 selling over-the-counter drugs in America today.

Prilosec Side Effects

Proton pump inhibitors like Prilosec have been linked to serious side effects including:

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)
Rebound Acid Hypersecretion (RAHS)
Gut infections
Clostridium difficile infection
Community-acquired pneumonia
Dementia
Erectile dysfunction (ED)
Severe allergic reactions
And more

Chronic Kidney Disease (CKD) and Kidney Failure

A February 2016 study published in JAMA Internal Medicine found that proton pump inhibitors like Prilosec increased the risk of chronic kidney disease (CKD) by 20-50%, and that the longer the drugs are taken, the greater the risk that patients develop the condition. Patients who took PPIs more than once per day also faced an increased risk of developing CKD, according to the study.

Two months after the JAMA study was released, another study published in the Journal of the American Society of Nephrology (JASN) linked long-term PPI use to a 96% increased risk of kidney failure (end-stage renal disease or ESRD) and a 26% increased risk of chronic kidney disease. This is the first major study to link PPIs to kidney failure.

“I think people see these medications at the drug store and assume they’re completely safe,” said Dr. Ziyad Al-Aly, lead author of the study. “But there’s growing evidence they’re not as safe as we’ve thought. [Patients should] use PPIs only when it is medically necessary, and should limit duration of exposure to the minimum necessary to treat the underlying medical condition.”

Acute Interstitial Nephritis (AIN)

In October 2004, AstraZeneca announced that it was aware of at least 200 cases of acute interstitial nephritis (AIN) linked to omeprazole (the active ingredient in Prilosec). AIN is a sudden allergic reaction in the kidneys which causes swelling and decreased kidney function.

In December 2014, FDA updated Prilosec warning labels to include information about acute interstitial nephritis. The agency said that AIN can occur at any time during treatment with the drug.

A study published in CMAJ Open in April 2015 linked long-term PPI use to a 2.5-fold increased risk of acute kidney injury and a 3-fold increased risk of acute interstitial nephritis. The findings were based on data from nearly 300,000 people in Canada over 66 years old who started taking a PPI between 2002 and 2011.

Heart Attack

A study published in PLOS ONE in June 2015 found that PPIs may increase the risk of heart attack by up to 21% compared to H2 blockers (Zantac, Pepcid, Tagamet), even in patients with no pre-existing history of heart disease. “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 December 2006 study published in the Journal of the American Medical Association (JAMA) found that long-term use of proton pump inhibitors may increase the risk of hip fractures in elderly patients. The research was followed by a May 2010 FDA Drug Safety Communication regarding an increased risk for fractures of the hip, wrist and spine with PPIs. Patients at greatest risk for fractures were patients who used proton pump inhibitors for 1 year or more, according to the agency.

Rebound Acid Hypersecretion (RAHS)

A study published in the journal Gastroenterology in 2009 found that proton pump inhibitors may cause “rebound acid hypersecretion” (RAHS), or a recurrence of acid-related symptoms, after 8 weeks of treatment which can lead to dependence on the medications. Subsequent research published in the Scandinavian Journal of Gastroenterology in May 2013 found that RAHS following PPI therapy induces reflux-like symptoms post-treatment in asymptomatic volunteers, “but the significance of this in patient populations is not clear.”

Birth Defects

After reports surfaced in 2010 of cardiac birth defects in babies born to mothers who took proton pump inhibitors during pregnancy, FDA concluded that there was no statistically significant link. However, Prilosec is classified in Pregnancy Category C, which means that animal studies have found potential fetal risk.

Hypomagnesemia (Low Magnesium Levels)

FDA issued yet another Drug Safety Communication on PPIs in March 2011, this time regarding an risk for the development of low magnesium levels (hypomagnesemia). In about 25% of cases reviewed, magnesium supplementation did not improve low serum magnesium levels and PPI therapy had to be discontinued.

PPIs Linked to Increased Risk of Pneumonia in Dementia Patients

April 5, 2017 – Dementia patients who take proton pump inhibitors have an 89% increased risk of developing pneumonia compared to dementia patients who don’t use the medications, according to a study published last month in the Journal of the American Geriatrics Society. Independent risk factors for pneumonia included age, male gender, underlying cerebrovascular disease, chronic pulmonary disease, congestive heart failure, diabetes mellitus, and antipsychotic use.

Prilosec Timeline

1989 – Prilosec approved by the FDA

Prilosec approved by the FDA as “Losec” to become the first proton pump inhibitor (PPI) drug to enter the U.S. market.

1990 – Losec changed to Prilosec

Losec changed to Prilosec after the name’s similarity to a diuretic medication caused numerous medication errors, including at least one death.

2004 – AstraZeneca announcement

AstraZeneca announces that over 200 cases of acute interstitial nephritis (AIN) had been linked to omeprazole (the active ingredient in Prilosec).

2006 – JAMA study

JAMA study finds increased risk of hip fractures in elderly patients who take proton pump inhibitors.

2009 – Study published in Gastroenterology

Study published in Gastroenterology finds that PPIs may cause rebound acid hypersecretion (RAHS) in patients after 8 weeks of treatment. RAHS may lead to dependence on PPIs, according to the researchers.

2010 – FDA issues Drug Safety Communication

FDA issues Drug Safety Communication regarding an increased risk of fractures of the hip, wrist and spine associated with PPI use.

2010 – New England Journal of Medicine study published

The New England Journal of Medicine (NEJM) publishes a study on birth defects in babies exposed to proton pump inhibitors in the womb. The researchers conclude that no association was found between PPI therapy and major congenital malformations.

2011 – FDA Drug Safety Communication issued

FDA Drug Safety Communication issued regarding an increased risk of hypomagnesemia (low magnesium levels) associated with PPI therapy.

2013 – Scandinavian Journal of Gastroenterology research published

Research published in the Scandinavian Journal of Gastroenterology finds that RAHS following treatment with proton pump inhibitors induces reflux-like symptoms, “but the significance of this in patient populations is not clear.”

2014 – FDA updates Prilosec warning labels

FDA updates Prilosec warning labels with information about acute interstitial nephritis (AIN).

2015 – Study published in CMAJ Open

Study published in CMAJ Open links long-term PPI use to a 2.5-fold increased risk of acute kidney injury and a 3-fold increased risk of nephritis.

2015 – PLOS ONE study findings

PLOS ONE study finds that PPI users have up to a 21% increased risk of heart attack compared to patients who take H2 blockers (Pepcid, Zantac, Tagamet).

2016 – JAMA Internal Medicine study published

Study published in JAMA Internal Medicine finds that PPI users have a 20-50% increased risk of developing chronic kidney disease (CKD).

2016 – Journal of the American Society of Nephrology study published

Study published in the Journal of the American Society of Nephrology (JASN) finds a 96% increased risk of kidney failure and a 26% increased risk of chronic kidney disease (CKD) associated with PPI use.