Conditions Treated by Proton-Pump Inhibitors
Over The Counter (OTC)
- Frequent heartburn
- Gastroesophageal reflux disease (GERD) or Acid Reflux
- Peptic ulcer disease (PUD) or gastric ulcer
- Duodenal ulcer
- Erosive esophagitis
- Zollinger-Ellison syndrome
Proton-pump inhibitors were first introduced in 1989 when the first PPI, omeprazole, was approved as “Losec”. The brand name of omeprazole was later changed to “Prilosec”. The second PPI, Prevacid (lansoprazole) was approved in 1995. Since that time, several more PPI medications have been approved, including Nexium (esomeprazole) which was approved in 2001 as a follow-up to Prilosec after patent expiration. In 2003, Prilosec became available without a prescription.
Prevacid and Nexium followed suit and are now available as over-the-counter (OTC) medications. Popular medications known as Proton-Pump Inhibitors (PPIs) are used to treat gastrointestinal ailments such as frequent heartburn and gastroesophageal reflux disease (GERD). These PPI medications work differently than other antacid drugs used to treat heartburn and related stomach ailments. They work by blocking acid production in cells of the stomach to prevent damage to the esophagus caused by reflux.
Overall, the antacid and heartburn medication market brings about $14 billion to manufacturers each year. PPI medications like Prilosec, Nexium and Prevacid have each made $billions for their manufacturers AstraZeneca and Takeda.
- Prilosec (omeprazole) – Approved 1989, peak sales year 2000 $6.3 billion
- Prevacid (pantoprazole) – Approved 1996, peak sales year 2003 $3.6 billion
- Nexium (esomeprazole) – Approved 2001, peak sales year 2007 $5.2 billion
When first approved, PPI users were warned of side effects like nausea and vomiting, stomach pain, diarrhea, headache, and dizziness but since their introduction, thousands of patients have experienced severe side effects and complications due to these medications. Many of these PPI users and family members have filed lawsuits against AstraZeneca or Takeda for injuries caused by their medications, Prilosec, Nexium and Prevacid. More than 4,200 of these lawsuits are pending in federal court and more may exist in state and local courts.
Millions of people have used PPIs like Prilosec, Nexium and Prevacid to treat heartburn, reflux and other stomach conditions every year. They have been promoted as a safe and more effective alternative to other antacid treatments and have been widely used in both prescription and OTC formulations.
In 2010, the results of two separate studies indicated emerging concerns over potential risks of PPI use, mainly an increased risk of bone fracture in the hip, wrist or spine. Based on these results, the Food and Drug Administration (FDA) determined that the risk was most prevalent in patients who were placed on higher doses and took them for a long period of time and did not require labeling changes or additional safety warnings.
Since that time, the number of studies have confirmed increased risks of PPI use and concerning a wider range of medical conditions.
Serious risks of PPI use may include:
- Bone fracture
- Acute kidney injury
- Chronic kidney disease
- Acute interstitial nephritis
- Low magnesium levels
- Heart attack
A 2016 study published in JAMA’s Internal Medicine showed PPI users may have a 20 to 50% increased risk for chronic kidney damage. Chronic kidney disease indicates decreasing kidney function which can worsen over time and lead to kidney failure, requiring a kidney transplant. Other studies have indicated a 21% increased risk of stroke and heart attack, increased risk of gastric cancer for certain patients, and demonstrated further evidence of bone fracture. Though rare, PPI use may also be linked to a skin condition known as erythroderma, which can be fatal.
Researchers have examined the potential for sudden and early death due to PPI use. When compared to other antacid medications such as H2 inhibitors, the 5-year death rate of PPI users may be as much as 50% higher due to medical complications caused by the drugs. Many of these complications may develop slowly over time and go unnoticed until significant disease progression has occurred.
AstraZeneca and Takeda Liability and Negligence
PPI manufacturers AstraZeneca (Prilosec, Nexium) and Takeda (Prevacid) are facing thousands of lawsuits for injuries caused by their medications. PPI lawsuits claim that the drugs were not tested properly and that the companies failed to adequately warn both the medical community and the public of potential risks.
PPIs were initially intended to be used to treat gastric or peptic ulcer disease (PUD) which can be diagnosed with imaging studies or through bacterial cultures. Later approvals expanded use to other disorders such as gastroesophageal reflux disease (GERD) which is diagnosed only by symptom, with no testing required.
In addition to the official “indications” or approved reasons for use, many doctors prescribed PPIs for a wider range of stomach disorders and for a longer time of use than had been studied. Because of the popularity, Prilosec, Prevacid, and Nexium were all top-10 selling prescription drugs during their peak, raking in $billions each year for AstraZeneca and Takeda.
When prescription sales became threatened by patent expiration or competing medications, both AstraZeneca and Takeda quickly moved to obtain approval to begin marketing their medications over-the-counter. OTC use which does not require a prescription may also eliminate a safety check at the physician’s office and allow vulnerable patients to use medications inappropriately or taking them for longer than safe.
Both companies have been accused of using aggressive marketing tactics on both health professionals and to consumers, of failing to warn of the risks of PPI use, and of placing profits above safety.
PPI Class Action Lawsuit Settlement
AstraZeneca settled a class action lawsuit in 2015 regarding both Prilosec and Nexium. The lawsuit claimed that the drug company had introduced Nexium only because the patent for Prilosec had run out. Though the drugs are nearly identical in chemistry, Nexium was promoted as an “improvement” over Prilosec but was much more expensive. AstraZeneca was accused of creating a deceptive marketing campaign to ensure that their product line was “evergreen” and would continue to provide a massive profit. The class action lawsuit was settled with a $20 million payout to participants.
PPI Medical Liability Lawsuit
As of May 2018, more than 4,200 lawsuits are pending in court. Federal cases against PPI manufacturers have been consolidated into a multi-district litigation (MDL) in the U.S. District Court for the District of New Jersey. MDL consolidation allows for the cases to be grouped so that lawyers for both plaintiffs and defendants can concentrate their efforts and address many lawsuits at one time.
MDL consolidation also allows for “bellwether” trials to be conducted on a small number of cases to determine how the remaining trials can be expected to go. In many cases, a high dollar award in a bellwether trial will lead to manufacturer-offered settlements for other group members.
The PPI MDL currently contains 4,248 lawsuits against manufacturers of PPI medications including Prilosec and Nexium (AstraZeneca), Prevacid (Takeda) and Protonix (Pfizer). Other PPI lawsuits may also be pending in state and local courts but no cases have been set for trial yet.
Qualifying for a PPI lawsuit
People who have experienced kidney damage, bone fracture or other serious side effects after taking Prilosec, Nexium or Prevacid may be eligible to file a PPI lawsuit.
Medical injury lawsuits may provide compensation for:
- Medical costs
- Lost wages
- Pain and suffering
- Future medical expenses
- Punitive damages
There are no guarantees that a PPI lawsuit would be appropriate or successful. Each case is unique and must be evaluated separately by a legal expert.
- Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease, JAMA Internal Medicine 2/2016
- FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, U.S. Food and Drug Administration 3/2011
- Prilosec OTC (omeprazole) Information 11/2015
- Nexium 24hr Product Label 2018
- Prevacid OTC, Drugs.com 4/2018
- 25 Years of Proton Pump Inhibitors: A Comprehensive Review, Gut, and Liver 11/2014
- Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population, PLoS One 6/2015