In recent years, Prilosec users have come forward with claims that the drug’s use led to the development of kidney disease and chronic kidney failure. Many people – thousands of them – have filed lawsuits in U.S. District Courts claiming that the drug caused them to suffer consequences, including kidney failure and that the manufacturer of the drug failed to warn them about the risks associated with its use.
Did you use Prilosec products? Did you develop any kidney disease or damage after doing so? If so, you may be entitled to compensation for your losses.
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What Is Prilosec?
Prilosec is a type of over the counter and prescription strength medication designed to reduce the production of acid in the stomach. The drug, also known as omeprazole, is used to treat the symptoms of gastroesophageal reflux disease (GERD). In this condition, the drug reduces the production of stomach acid that otherwise backs up into the esophagus, causing burning and pain. According to the National Library of Medicine, this drug can be used for other conditions.
This drug is a proton-pump inhibitor. There are other medications like it on the market that are designed to do the same thing – reduce the production of acid produced by the stomach.
All Names for Prilosec
- Prilosec OTC
- Talicia (which is a combination of omeprazole, amoxicillin, and rifabutin)
- Zegerid (which includes omeprazole and sodium bicarbonate)
- Zegerid OTC (which contains omeprazole and sodium bicarbonate)
How Is Prilosec Used?
Prescription medications are obtained through a doctor’s appointment and careful diagnosis of GERD or a related condition that is caused by too much acid in the stomach. This medication is a delayed release medication that breaks down over time. The prescription version is taken one time a day, most of the time, before consuming a meal, but may be taken up to twice a day in some cases.
The non-prescription, over the counter version is taken on time per day at least 1 hour prior to eating. This medication can be taken only for 14 days in a row. It may be possible to repeat treatment, but doing so only one time per four months is acceptable.
The medication now features numerous warnings about taking it too often or outside of the recommendation of a doctor.
History of Prilosec
Prilosec has been on the market since 1989, though its formation has changed over time. It was released by Astra AB, which is now known as AstraZeneca. It was the first proton pump inhibitor (PPI) that was commercially available in the U.S, according to the American Chemistry Society. The drug worked to block the release of stomach acid into other areas of the digestive tract.
When it was first released, the drug was available by prescription only. It was also sold under the brand name Losec. However, the Food and Drug Administration (FDA) requested that the name be changed because it was too similar to Lasik, a diuretic.
However, it was released as an over the counter medication with a slightly different formulation. The company’s patent on Prilosec expired in 2001, and since then, other manufacturers have produced generic versions of the drug.
After the drug’s patent expired, AstraZeneca released Nexium, also known as esomeprazole. This is a patented replacement drug. Both products continue to be made and used around the world.
What Side Effects Can Omeprazole Cause?
There are some noted possible side effects when using Prilosec. According to the National Library of Medicine, this includes the risk of:
Other potential side effects can be serious. These include:
- Blisters, bleeding or peeling skin
- Swollen glands
- Flu-like symptoms
- Shortness of breath
- Rash or hives
- Swelling of the face, eyes, lips, throat, tongue, or mouth
- Trouble breathing
- Excessive tiredness
- An irregular, pounding, or fast heart rate
- Severe diarrhea with watery stool
- Stomach pain
- Fever that does not resolve
These are considered reasons to stop using the drug and talk to a doctor.
An additional side effect was added that relates to the increased risk of fractures to the hips, wrists, or spine in people who take PPIs. There is also the risk of fundic gland polyps, which are a type of growth that occurs on the stomach lining.
Research Findings About Prilosec
There have been several claims made against PPIs. One of the most notable related to Prilosec is the claim that the use of this drug causes kidney damage. It is important to note that not everyone using Prilosec will develop this condition. However, some people have and, as a result, have filed a lawsuit in U.S. District Court over their losses.
Let’s take a closer look at what occurred.
In 2016, a study published by the Journal of the American Medical Association (JAMA) found that proton pump inhibitors were linked to the onset of chronic kidney disease. This study was large, involving over 10,000 people. It wanted to determine if there was any increased risk to a person who took these medications over a period of time compared to those that did not. Half of the patients were given the medication, and half were not.
The study found that the people that took Prilosec or other types of PPIs were at a much higher risk of developing chronic kidney disease. Their risks of developing this condition rose by between 20 and 50 percent compared to the people that did not use these medications. The conclusion of this large study found that there is a link between the use of the medication and chronic kidney disease, which is a life-threatening condition that can be hard to treat and is not always curable. The study recommended that there should be limited use of PPIs – which are used by millions of people around the world – to prevent the onset of the disease.
Also notable was another study, this time published by the Journal of the American Society of Nephrology. It found that there is a 96% higher risk of developing kidney failure, including end-stage renal disease, with long term use of PPIs. There is also a 26% increase in the risk of developing chronic kidney disease. It found that even people that took the drug just one time a day were at an increased risk of developing complications related to their kidneys.
Acute interstitial nephritis is another key condition. This one dates back to 2004. At that point, the manufacturer, AstraZeneca stated they had learned of about 200 cases in which users of the PPI developed acute interstitial nephritis, a type of inflammation of the kidneys. It is a type of sudden and life threatening reaction that occurs in the kidneys. It leads to decreased kidney function. As a result of this onset, the FDA issued a requirement for this risk to be added to the warning labels for Prilosec products.
Other Claims Against Prilosec
It is important to note this is not the first time these drugs have been studied, and people have suffered from their continued use, allegedly.
In another study published by the National Library of Medicine, a review of the long-term effects of PPIs was looked at. The first thing noted in the study is that between 25 and 70 percent of people taking PPIs should not be. These individuals do not have the indications to warrant the use of the drug. Yet, because PPIs are available over the counter, there is no doctor’s prescription required to obtain them.
This study found that those who took these drugs were at a much higher risk for developing Vitamin B12 deficiency. They also suffered from calcium and magnesium malabsorption and other health conditions.
Other studies have linked PPIs, including Prilosec, to other complications, including:
- A higher risk of heart attacks, from a study published in 2015, found a 21% increase in people using these products compared to H2 blocks, such as Pepcid and Zantac.
- Bone fracture risks are also likely, according to a JAMA study that found a link between the use of PPIs and a higher risk of hip fractures. This led to a warning on the product being added.
There are other claims as well, including those related to birth defects, rebound acid hypersecretion, and hypomagnesemia.
Is Prilosec Recalled by the FDA?
The Food and Drug Administration has not recalled Prilosec, though it has recalled other types of antacids and PPIs. The FDA has not recommended that people stop using this product.
Lawsuit History Against Prilosec
A number of lawsuits have occurred over the last decade that have involved Prilosec. The most significant of them is related to kidney disease claims made by many people. One of the core concerns with kidney disease claims is that the people using the drugs were overusing them and that they were not taking them as directed. However, the people using these drugs stated that they did not know of the risks and were not warned of them.
Some lawsuits against Prilosec claim that the manufacturer knew about the risks associated with the use of this drug and its impact on kidney health as far back as 2004. They state that the company did not do anything to warn patients about the increased risk for over 10 years.
These lawsuits claim that their use of Prilosec products led to:
- Kidney disease
- Kidney injury
- Kidney failure
- Chronic kidney failure
- Acute interstitial nephritis
What are the Latest Updates in Prilosec Lawsuits?
There are thousands of pending lawsuits against the company. In February 2017, the U.S. Judicial Panel made the decision to create a single multidistrict litigation for the numerous claimants against the company. The case is being presided over by U.S. District Judge Claire C. Cecchi in the U.S. District Court of New Jersey.
Currently, the bellwether cases related to the case are heading to trial. That means that the first cases that are likely to lead to a verdict are in play now. There have not been any noted class action lawsuit awards as of yet.