Aciphex 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 drug Aciphex has been linked to serious side effects including chronic kidney disease, acute interstitial nephritis, kidney failure, bone fractures and more. Patients who suffered kidney damage after taking Aciphex may be able to file a lawsuit seeking compensation for their injuries.

What is Aciphex?

Aciphex (generic: rabeprazole) is a proton pump inhibitor (PPI) medication that decreases the amount of acid produced in the stomach. The drug is used short-term to treat the symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1-year-old, and in adults only to treat conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Aciphex is made by Eisai Inc., and was first approved by the U.S. Food & Drug Administration (FDA) in February 2002.

Aciphex Side Effects

Proton pump inhibitor heartburn medications like Aciphex 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)
Rebound Acid Hypersecretion (RAHS)
Gut infections
Clostridium difficile infection
Community-acquired pneumonia
Dementia
Erectile dysfunction (ED)
Severe allergic reactions
And more

Chronic Kidney Disease / Kidney Failure

A JAMA Internal Medicine study published in February 2016 found that proton pump inhibitor use 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 will develop the condition. Two months later, a 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 and a 26% increased risk of CKD. This is the first major study to link proton pump inhibitors to kidney failure.

Acute Interstitial Nephritis

Acute interstitial nephritis (AIN) is a rare but important cause of kidney failure (end-stage renal disease or “ESRD”) which has been increasingly linked to proton pump inhibitors like Aciphex. AIN occurs when the kidneys are unable to filter wastes properly because of inflammation, which causes symptoms such as swelling of the body, rash, vomiting, weight gain and blood in the urine.

The first case of acute interstitial nephritis specifically linked to Aciphex in the U.S. was reported in 2005. At least 4 cases have been reported in the medical literature in Canada, as well as one in France. As a result of these problems, FDA in December 2014 updated Aciphex warning labels to include information about acute interstitial nephritis.

Heart Attack

In June 2015, a study published in PLOS ONE found that proton pump inhibitors may increase the risk of heart attack by 16-21% compared to H2 blocker heartburn medications, even in patients with no 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 study’s authors said. “And H2 blockers show no such association.”

Bone Fractures

The Journal of the American Medical Association (JAMA) in December 2006 published a study indicating that long-term PPI use may increase the risk of hip fractures in elderly patients. FDA warned of an increased risk of fractures of the hip, wrist and spine with the drugs in May 2010. Patients at the greatest risk for fractures were those who used PPIs for 1 year or more, the agency said.

Rebound Acid Hypersecretion

A 2009 study published in Gastroenterology found that PPI heartburn drugs may cause “rebound acid hypersecretion” (RAHS), or a recurrence of acid-related symptoms, after as little as 8 weeks which can lead to dependence on the drugs. Another study published in the Scandinavian Journal of Gastroenterology in May 2013 found that RAHS following proton pump inhibitor use causes reflux-like symptoms post-treatment, “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 used PPIs in pregnancy, FDA concluded that no such link had been established. Aciphex is classified in pregnancy category B, which means that animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Hypomagnesemia

FDA warned in March 2011 about an increased risk of hypomagnesemia, or low magnesium levels, associated with PPI use. In about 25% of cases reviewed by the agency, magnesium supplementation did not improve the condition and patients were forced to quit taking the medications.

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.

Aciphex Timeline

2002 – Approved by the FDA

Aciphex approved by the U.S. Food & Drug Administration (FDA).

2005 – Acute Interstitial Nephritis case

First U.S. case of acute interstitial nephritis (AIN) linked to Aciphex in the medical literature.

2006 – JAMA study findings

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

2008 – Another acute interstitial nephritis case reported

Case of acute interstitial nephritis reported in an 84-year-old French woman who was hospitalized for renal failure after taking Aciphex.

2009 – Gastroenterology study published

Study published in Gastroenterology determines that PPI use may cause “rebound acid hypersecretion” (RAHS), which can lead to dependence on the medications.

2010 – FDA Drug Safety Communication issued

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

2011 – FDA warns of hypomagnesemia risk

FDA warns of increased risk of hypomagnesemia, or low magnesium levels, associated with PPI use.

2012 – More acute interstitial nephritis cases reported

Four cases of acute interstitial nephritis associated with Aciphex reported in Canada.

2013 – FDA approves first generic versions of Aciphex

FDA approves first generic versions of Aciphex delayed-release tablets to treat gastroesophageal reflux disease (GERD).

2014 – Warning label updates

FDA updates Aciphex warning labels with information about acute interstitial nephritis.

2015 – PLOS one study findings

PLOS one study finds 16-21% increased risk of heart attack associated with PPI use.

2016 – JAMA Internal Medicine study findings

JAMA Internal Medicine study finds that proton pump inhibitors increase the risk of chronic kidney disease (CKD) by 20-50%.

2016 – Journal of the American Society of Nephrology Study published

Study published in the Journal of the American Society of Nephrology (JASN) links long-term PPI use to a 96% increased risk of kidney failure and a 26% increased risk of CKD. This is the first major study to link PPIs to kidney failure.