Proton Pump Inhibitor
Truth: Proton pump inhibitors are among of the most commonly-used medications in the world – yet many users are completely unaware of the life-threatening side effects they can cause.
Truth: It’s estimated that more than 4,000 lawsuits have been filed by individuals who have experienced severe complications, like disease and failure of the kidney and renal system.
Truth: Data shows that it’s difficult for patients to quit taking PPIs, as many report that their symptoms are worse after quitting than when they started in the first place.
As a result of extensive (and sometimes deceptive) marketing and easy over-the-counter availability, proton pump inhibitors like Prilosec, Nexium, and Prevacid have become one of the most popular types of medication in the world. In fact, in one of its peak years, Nexium alone earned more than $5 billion in revenue.
Despite a number of studies and FDA warnings suggesting severe complications from long-term use, many consumers simply don’t know about the harm they cause. Thousands of lawsuits are claiming that PPI manufacturers are well-aware of the possible side effects, but consistently fail to include proper drug warnings or increase their efforts to educate consumers and doctors who prescribe them.
If you feel that you’re a victim, contact us now. We’ll stand up to big corporations and fight for the compensation you deserve.
What Is a Proton Pump Inhibitor?
Proton pump inhibitors (PPIs), commonly known as heartburn medication, are prescription and over-the-counter (OTC) medications used to treat digestive issues including, but not limited to:
- Heartburn and acid reflux
- Dyspepsia, or indigestion
- Gastritis, or stomach lining inflammation
- Gastroesophageal reflux disease, or GERD
- Barrett’s esophagus, a cancer-causing GERD complication
- Erosive esophagitis, or acid buildup causing damage to the esophagus
- Prevention of gastrointestinal bleeding in platelet therapy patients
- Peptic ulcers, or open sores in the lining of the stomach and small intestine
- Conditions like Zollinger-Ellison syndrome, which cause recurrent peptic ulcers
While most PPIs are taken in pill form, injectable liquid forms are also given via IV, or intravenously, to hospital and medical facility patients. OTC versions can be found in virtually any drugstore in America.
Most Popular PPIs on the Market
Prilosec (omeprazole) was the first FDA-approved PPI in 1989. As of November 2018, there are six PPIs that have received FDA approval. Here is a list of these PPIs and some of the brand names they’re sold under, either in over-the-counter or prescription form:
Generic Name Brand Name(s) Omeprazole Prilosec, Losec, Omesec, Zegerid Esomeprazole Nexium, Vimovo Lansoprazole Prevacid Pantoprazole Protonix Dexlansoprazole Dexilant, Kapidex Rabeprazole AcipHex
Note: Some brand names listed above, and their OTC versions, contain a combination of the generic medication and other ingredients, like magnesium, sodium, or other medications.
How Do Proton Pump Inhibitors Work?
As indicated by the name, PPIs interfere with the body’s proton pumps, which are the chemical systems that produce stomach acid. By blocking these pumps, PPIs decrease the production of stomach acid.
Stomach acid, also called gastric acid, helps to digest our food and allow our bodies to absorb essential nutrients. However, it’s highly corrosive and has the potential to cause severe damage to our digestive system. To prevent this, our digestive systems have special protective lining and other mechanisms.
When individuals have issues or disorders of these protective mechanisms, or if their bodies produce too much stomach acid, they may experience severe pain and long-term damage to the stomach and esophagus, or the canal that connects the throat and stomach.
By reducing or blocking stomach acid, PPIs can help restore quality of life for these patients when used appropriately.
Misleading Marketing and PPI Overuse
Many of the lawsuits against proton pump inhibitor manufacturers are related to the aggressive marketing that led to overuse of the over-the-counter (OTC) versions. Many claim that advertisements and endorsements were positioning PPIs as daily heartburn prevention.
For example, in a 2012 TV commercial, comedian Larry the Cable Guy says, “If you’re one of those people who gets heartburn and then treats, day after day, block the acid with Prilosec OTC – and don’t get heartburn in the first place.”
The commercial goes on to say, “One pill each morning. 24 hours. Zero heartburn.”
While the small print at the bottom of the screen warns not to take Prilosec OTC for more than 14 days or more often than every four months, the commercials suggested that it was a long-term fix for frequent heartburn.
In addition to consumer advertisements for OTC versions, the lawsuits claim that manufacturers also aggressively pushed the prescription forms so that doctors would use them to treat patients. However, manufacturers failed to emphasize the dangers of overuse, which further contributed to consumers (and their doctors) being misled.
What Are the Risks of Taking Proton Pump Inhibitors?
There’s a long list of side effects and risks associated with PPI use, ranging from mild to life-threatening.
As of late 2018, the FDA has released three Drug Safety Communications to warn consumers about key PPI side effects:
- 2010: High PPI doses can lead to increased risk of wrist, hip, and spine fractures.
- 2011: Long-term PPI use could increase the risk of hypomagnesemia, or low magnesium levels. Hypomagnesemia can cause muscular and neurological effects like seizures and irregular heartbeat.
- 2012: PPI use is associated with increased risk of Clostridium difficile-associated diarrhea (CDAD), a type of non-improving diarrhea caused by the dangerous bacteria Clostridium difficile. CDAD has been directly linked to patient death.
Apart from these warnings, many PPI users have suffered kidney damage and failure, which are among the most common reasons patients have filed lawsuits against PPI manufacturers.
Other risks include dementia, nutritional deficiencies, and higher risk of other dangerous infections like pneumonia.
Kidney Damage and Failure
It’s estimated that there are more than 4,000 federal lawsuits against PPI manufacturers from users who suffered various issues. The most common conditions in these lawsuits involve severe kidney damage or complete kidney failure.
The main function of our kidneys is to filter the waste and toxins from our blood, which is then passed from the body through our urine. The kidneys also help with regulating healthy water and nutrient balances in our blood, promoting bone health, regulating blood pressure, and other critical health functions.
When the kidneys are damaged, or function is impaired, there can be devastating – and even deadly – consequences.
Certain conditions like chronic kidney disease (CKD) and acute interstitial nephritis (AIN) can lead to acute or chronic kidney failure, also called acute or chronic renal failure.
- Acute failure: damage occurs severely and suddenly, often over the course of hours or days
- Chronic failure: damage occurs gradually over time, over several months or even years
In kidney or renal failure, also called end-stage renal disease (ESRD), the kidneys become unable to filter the waste from the patient’s blood. They may eventually stop working, which can endanger the patient’s life if they don’t receive immediate medical treatment.
In severe cases, patients may need frequent or daily dialysis, which is a process that artificially performs the kidney’s blood-cleansing functions. Patients may also need a kidney transplant to replace failed kidneys.
If you’ve been taking PPIs and believe that it has contributed to debilitating side effects like kidney disease or failure, contact us immediately. We’ll do our best to find justice for you and your family, and we won’t ask for compensation unless you win your case.
Acute Interstitial Nephritis
The first research linking PPI use to acute interstitial nephritis (AIN) was released more than a decade ago, in 2006. AIN is a kidney condition that causes inflammation and death in the tissue that surrounds and supports the main structures of the kidneys.
If the condition goes undiagnosed and the patient continues using PPIs, AIN can lead to acute or chronic kidney failure.
Blood in the urine Nausea and vomiting More or less urination than normal Body rash Fever Tiredness and lethargy Mental changes, like confusion General malaise, or feeling unwell Unexplained weight loss*
*Note: In contrast, weight gain may occur in patients with AIN that wasn’t associated with PPI use.
Chronic Kidney Disease
In February 2016, JAMA Internal Medicine released a study called “Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.”
The study examined more than 10,000 individuals, concluding that PPI use was associated with higher risk of chronic kidney disease (CKD). In CKD, the patient gradually loses kidney function, which can lead to kidney failure and eventually death.
Higher risk was seen in those who take PPIs more frequently and for longer durations. In short: the more individuals used PPIs, the higher their risk. This also meant higher risk for CKD’s life-threatening complications.
The study also found that many individuals taking PPIs took them for longer periods of time than the recommended guidelines.
The FDA recommends over-the-counter PPIs should be used no longer than 14 days, up to three times per year.
Additionally, many of these individuals didn’t necessarily need to be taking the medication in the first place, suggesting that it’s commonly over-prescribed and over-used.
Symptoms of chronic kidney disease include:
Nausea and vomiting Loss of appetite Muscle cramps and twitches More or less urination Lower mental sharpness Persistent itching Weakness and fatigue Ankle and foot swelling Problems sleeping Chest pain from fluid buildup around the heart Shortness of breath from fluid buildup inside the lungs Hypertension, or high blood pressure. If you’re taking PPIs and experience any of these symptoms, contact your doctor immediately.
Other PPI Risks and Their Warning Signs
Many studies have shown a connection between PPI use and bone fractures. A recent meta-analysis that looked at the results of 18 different studies showed that PPI use had an increased fracture risk of:
- 33% for any area of the body
- 58% for spine fractures
- 26% for hip fractures
It’s believed that PPI therapy decreases the body’s ability to absorb calcium, which in turn decreases an individual’s bone mineral density. Research suggests that calcium absorption can decrease after as little as one week of PPI use.
Another theory is that PPIs have a negative impact on our bodies’ natural osteoclastic activity, which is a process that influences how our bones are structured by using certain types of bone cells (osteoclasts) to break down bone tissue.
Research suggests that PPIs can contribute to the development of dementia. A 2015 study looked at more than 3,000 patients who were 75 years or older and had no prior history of the condition.
Results showed that subjects who used PPIs had a 38% higher risk of dementia and 44% higher risk of Alzheimer’s disease.
Another study in 2016 showed very similar results, with 44% of its more than 73,000 subjects showing an increased risk of dementia with PPI use.
It’s believed that the generic PPI lansoprazole, which is most commonly found in the brand name medication Prevacid, can cause higher levels of a particular brain peptide that’s linked to Alzheimer’s.
Additionally, many researchers believe that patients who have a vitamin B12 deficiency while using PPIs are at higher risk of developing neurologic issues like dementia.
Symptoms of dementia include:
- Cognitive changes, like memory loss and confusion, as well as difficulty with communicating, problem-solving, planning and organizing, and handling complex tasks
- Physical changes, like a decrease in motor functions and coordination
- Psychological changes, like depression and anxiety, paranoia, changes in personality, inappropriate behavior, agitation, and hallucinations
Stomach acid is a critical way to break down and digest the foods we eat, which in turn helps us absorb needed minerals, vitamins, and other nutrients from those foods.
Therefore, a lack of stomach acid can significantly reduce the absorption of these nutrients – nutrients that help to keep our bones strong and prevent chronic disease.
In addition to hypomagnesemia, as noted in the FDA’s 2011 Drug Safety Communication, vitamin B12 deficiency is another risk associated with PPI use. This deficiency can lead to nerve damage, anemia (shortage of red blood cells), intestinal problems, muscle weakness, and mood problems.
Other PPI Side Effects
Research suggests that PPIs may increase the risk of infection, including food poisoning from salmonella and the lung infection pneumonia.
PPI users often report other, non-life-threatening issues, including:
- Nausea and vomiting
- Constipation, gas, and diarrhea
- Joint and muscle pain
- Skin issues like rashes
Proton Pump Inhibitor Lawsuits
There are currently thousands of lawsuits against various PPI manufacturers. In August 2017, the U.S. Judicial Panel agreed to consolidate more than 4,000 PPI lawsuits into a multidistrict litigation (MDL) case in New Jersey’s U.S. District Court.
When this MDL was created, four prescription PPIs and three over-the-counter PPIs were listed:
Prescription PPIs Over-the-Counter PPIs Prilosec Prilosec OTC Nexium Nexium 24-Hour Protonix Prevacid 24-hour Dexilant
The plaintiffs, or individuals filing the lawsuits, are claiming that they experienced acute interstitial nephritis, chronic kidney disease, and end-stage renal disease (or renal/kidney failure).
Manufacturers facing claims include:
- Proctor & Gamble
- Takeda Pharmaceuticals
- Pfizer and its subsidiary Wyeth
- Navartis Pharmaceuticals
The first bellwether trial is expected to begin in 2020. Bellwether trials are the first of their kind, aimed to set an example for how future trials might be handled.
From the results of this trial, the public will be able to better understand the definitive issues and connections between PPIs and their risks, the types of compensation victims will receive, the penalties manufacturers will receive, and how manufacturers will attempt to settle the many cases left.
When Should I Contact a PPI Lawyer?
You may have a case if you or a loved one has been taking prescription or over-the-counter proton pump inhibitors and has experienced severe complications like:
- Chronic kidney disease
- Acute interstitial nephritis
- End-stage renal disease, or kidney failure
- The need for a kidney transplant or frequent dialysis
- Other complications, like bone fractures, dementia, or life-threatening infections
You may be able to get financial compensation for you and your loved ones’ pain and suffering, medical bills, and lost wages from missed work.
We’re dedicated to holding PPI manufacturers responsible for the medications they’re providing the public. Don’t wait – contact us today to see if you have a case.
Co-counsel will be associated on these cases.