Proton-pump inhibitors (PPI) are primarily used for acid reflux and heartburn and have, over the years, found that they have become connected to some serious complications. PPI complications are severe and can range from bone fractures to kidney disease. Manufacturers of Prilosec, Nexium, and Prevacid, are facing almost 4500 proton pump inhibitor lawsuits between them, these are all for complications caused by medication.
What Are Proton-Pump Inhibitors & What Do They Treat?
Proton-pump inhibitors are a group of medicines that has a primary purpose; that purpose is the long-lasting reduction of the acid in the stomach.
Proton-pump inhibitors can either be purchased over the counter or will be prescribed for some issues. The over the counter use for PPIs is generally heartburn. When it comes to prescriptions, they have many more applications.
Proton-pump inhibitors on prescription are generally used to treat acid reflux, peptic ulcer disease, erosive esophagitis, duodenal ulcers, and Zollinger-Ellison syndrome.
The initial introduction of Proton-pump inhibitors was in the late 80s and was released under the general brand of “Losec” this was the brand name of omeprazole, and it was later rebranded to become “Prilosec.”
It wasn’t until 1995 that we got a second approval, which was Prevacid, and since then, we have seen the introduction of several more brands, including Nexium.
Since their introduction, the antacid market has seen exponential growth and brings in around $14 billion to manufacturers every year. The three leading companies Prilosec, Prevacid, and Nexium, all generate between $3 and $6 billion per year for their manufacturers Takeda and AstraZeneca.
Upon their first approval, all of the medicals came with side effects like vomiting, nausea, diarrhea, headache, stomach pain, and dizziness, but since their introduction, thousands of patients have experienced far worse.
Many of the people who have experienced severe complications and side effects have now filed lawsuits against Takeda and AstraZeneca. These lawsuits are for injuries caused by their medications Prevacid, Nexium, and Prilosec. More than 4000 lawsuits are pending in federal court, and many more are thought to exist in state courts too.
Proton-Pump Inhibitors Dangers
While usually touted as a safe and effective treatment in comparison to other antacids, Nexium, Prilosec, and Prevacid have been used by millions to treat heartburn, reflux, and stomach issues.
In 2010 concerns were raised due to the results of two independent studies. The studies had found there were concerns over the Proton-Pump Inhibitor use and the increased risk to fractures of the wrist, hip, and spine.
Based on the results of this study, the FDA concluded that there was a specific high risk in patients that were on higher doses over a long period of time. Since this point, there has been a great deal of studies, and they have confirmed PPI use can increase the risk of an array of medical issues, including:
- Bone fracture
- Acute kidney injury
- Low magnesium levels
- Heart attack
A more recent study conducted in 2016 successfully showed that Proton-Pump Inhibitor users have up to a 50% increased risk of chronic kidney damage. Other studies have gone on to show that users have a 21% increased risk of heart attack and stroke and also an increase in the risk of gastric cancer.
Independent researcher and medical studies have managed to jointly examine the potential for sudden or early death due to Proton-Pump Inhibitor use. When placed in a comparative study with other antacid medicine, the five-year death rate of Proton-Pump Inhibitor users may be increased by up to 50%. This increase is generally connected to the medical complications that are caused by drugs.
Proton-Pump Inhibitors & Kidney Disease
While every medication is bound to have side effects, Proton-Pump Inhibitors present one significant danger that can be life-changing. More and more studies are happening every day, and they are linking drugs like Nexium and Prilosec to increased risk of chronic kidney disease.
There was a time that the evidence that linked Proton-Pump Inhibitors and kidney disease was lacking, to say the least. The studies showed a link between Proton-Pump Inhibitors and kidney problems, such as interstitial nephritis. However, the studies then fell by the wayside when it came to linking the medication to chronic kidney disease.
More recent studies, however, found that Proton-Pump Inhibitor use can be associated with chronic kidney disease. In fact, the risk flew up by almost 50%.
There are several symptoms that are associated with chronic kidney disease, so if you are taking Proton-Pump Inhibitors and feel any of the following, you should communicate with your doctor immediately:
- Sleeping issues
- Itchy & dry skin
- Lacking in energy
- Difficulty concentrating
- Swelling of ankles and feet
- Increased need to urinate
- Muscle cramps.
There are, of course, numerous symptoms to be aware of, and these are but a few. There are a few factors that play a determination in the risk that Proton-Pump Inhibitors offer to your body.
You should be considering how long you have been taking the medication and the dosage you take. If you are a patient that has been taking high dosage Proton-Pump Inhibitors for many years, you will be at higher risk than most patients.
You should also take into account the brand of the Proton-Pump Inhibitor, for example, if you are taking Nexium, Prevacid, or Prilosec you may also be at increased risk for the aforementioned bone fractures. These drugs are also known for their presentation risk in benign polyps and abnormal tissue growths in the stomach. While these growths aren’t dangerous, they can be very disturbing.
Proton-Pump Inhibitor Liability & Negligence
The manufacturers AstraZeneca and Takeda, who are responsible for Nexium, Prilosec, and Prevacid, are, as mentioned, facing thousands of lawsuits due to injuries and complications that have been caused by their medications.
The claim states that the drugs were not tested properly and that there was an insufficient warning to the patients and medical professionals.
While Proton-Pump Inhibitors were introduced initially with the intention of treating peptic or gastric ulcer disease, which is primarily diagnosed via cultures or imaging, later in the testing stage, the approval was granted for use in the treatment of GERD which is only confirmed by diagnosing symptoms.
In addition to the approved reasons for use, a high number of medical professionals were prescribing Proton-Pump Inhibitors for a plethora of stomach disorders, and for a more extended period than had been tested.
Due to their popularity, Prevacid, Nexium, and Prilosec were all best-selling drugs and brought in billions per year.
When prescription levels came under threat by the expiration of a patent or competing for medication, both Takeda and AstraZeneca motioned to sell their medicines as over-the-counter. Introducing a drug for OTC usage can have serious implications as the safety aspect is eliminated, and patients may over-medicate and take them for longer than necessary.
Both Takeda and AstraZeneca have come under accusation for using marketing tactics that were deemed to be aggressive. The aggressive marketing tactics were used on both consumers and the general public. In essence, both companies effectively gave priority to profits over safety.
PPI Lawsuits & Settlements
In 2015, AstraZeneca was involved in a class-action lawsuit, which they settled. The lawsuit was concerning both Nexium and Prilosec. The lawsuits claimed that AstraZeneca had only decided to introduce Nexium as the Prilosec patent was running out.
The two drugs are nearly chemically identical, but Nexium was harshly promoted as an improved drug over Prilosec. In reality, it was very much the same, just far more expensive. AstraZeneca faced accusations of aggressive and deceptive marketing in order for their products to maintain a high-profit margin.
The lawsuit came to a close when AstraZeneca agreed to pay a $20 million payout to participants.
Proton-Pump Inhibitors Medical Liability Lawsuit
In May 2018, it was confirmed that 4200 lawsuits were pending against the two manufacturers. All federal cases against AstraZeneca and Takeda have been successfully consolidated into an MDL in the United States District Court for the District of New Jersey. MDL consolidation exists to allow a significant amount of cases to undergo grouping that the defendant and plaintiff lawyers can address multiple lawsuits at one time.
MDL also allows for bellwether trials to go ahead on a smaller number of cases. Doing this helps to determine the outcome of the remaining trials. In a majority of cases, a high dollar award will often lead to manufacturer settlements being offered to other group members.
If you have been taking Proton-Pump Inhibitors for a long time and experiencing symptoms mentioned in this post, you may be able to make a PPI lawsuit.