If you or a loved one have developed chronic kidney disease or suffered kidney failure after daily use of prescription or over-the-counter strengths of brand-name Prilosec, you may be eligible for compensation.
Prilosec Chronic Kidney Disease Lawsuit
A recent study has shown that Prilosec and other Proton Pump Inhibitor (PPI) medications may increase the risk of developing chronic kidney disease. You may be eligible for financial compensation through a Prilosec lawsuit if you or a loved one have experienced chronic kidney disease or other serious medical injury after taking Prilosec.
In February of 2016, JAMA, the Journal of the American Medical Association published results of a study showing that people who take Prilosec and other Proton Pump Inhibitor (PPI) medications may have a 20 to 50 percent increased risk of chronic kidney disease (CKD). The longer the medication is taken, the greater the risk.
This is not the first safety concern that has been raised by Prilosec, with issues reaching back to 2002. Prilosec has been shown to:
- Increase the risk of chronic kidney disease
- Increase the risk of heart attack
- Increase the risk of bone fracture
- Increase the risk of low magnesium levels or hypomagnesemia
Patients or their families may be eligible for compensation for medical costs, loss of wages and pain and suffering due to medical injury caused by Prilosec. If the medication’s use resulted in a death, family members may be eligible for wrongful death damages awarded in a Prilosec lawsuit.
Past lawsuits filed against drug manufacturers whose medications resulted in injury have claimed that those companies:
- Produced a dangerous or defective drug
- Failed to provide adequate warnings about risks of drug
- Knowingly hid dangers of medication from public and medical community
- Marketed the medication in an improper or illegal way
Some victims have filed Prilosec lawsuits in the past for other injuries but no settlements have been reached. This new information regarding increased risk of chronic kidney disease may mean that more patients will do so.
Filing a lawsuit against a drug manufacturer carries no guarantee of success or settlement and each potential case of medical injury must be evaluated separately.
Originally approved in 1988 as “Losec”, Prilosec was the first member of the Proton Pump Inhibitor (PPI) class of medications, used to treat gastroesphageal reflux disease (GERD) and peptic ulcer disease (PUD). These medications work differently from the way that other antacid or anti-ulcer drugs work, by blocking the proton pumps which release acid into the stomach. In 1990, the name Losec was changed to “Prilosec” after the name’s similarity to a common antidiuretic medication caused numerous medication errors, resulting in at least one death.
Prilosec’s manufacturer, AstraZeneca has estimated annual earnings of $26 billion. Prilosec sold at a rate of $6.1 billion in its peak sales year of 2000. In 2001, after Prilosec’s patent expired, its manufacturer, AstraZeneca introduced a “next generation” formulation of Prilosec, “Nexium”. Prilosec became available over-the-counter in 2003. Over-the-counter sales of Prilosec were nearly $400 million in 2013 and it continues to be one of the top five OTC medications.
AstraZeneca has faced legal trouble over its PPI medications. The company settled a $20 million class action lawsuit related to deceptive marketing of Nexium and also settled price-fixing lawsuit in multiple states for overcharging government programs. In addition, they may still be facing criminal penalties for illegal practices to delay manufacturing of a generic formulation so that prices would remain high.
The PPI group of medications now includes nine drugs such as Nexium and Prevacid. Several of these medications, including Prilosec, Nexium and Prevacid, are now available as over-the-counter medications without a doctor’s prescription. Up to 14 percent of adults in the U.S. have received Prilosec or other PPI prescription medications but many more may have taken OTC versions as well.
Proton Pump Inhibitor Warnings
In the February 2016 issue of JAMA, results of a large study involving the medical records of over ten thousand patients showed that Prilosec and other PPI use may increase the risk of the development of chronic kidney disease (CKD) by 20 to 50 percent. Study results indicated that the longer Prilosec was taken, the greater the risk. Patients who took the medication more than once per day also faced a greater risk.
This was not the first time that Prilosec had caused serious concerns, following shortly after a June 2015 PLOS One article showed that PPI drugs may increase the heart attack risk by up to 21 percent, even if the patients had no history of heart disease.
Other safety events and warnings issued by the FDA have included:
- In 1990, the “Losec”, name was changed to Prilosec after at least one death occurred due to medication errors caused by the name’s similarity to another common medication, Lasix. Unfortunately, this also led to confusion with Prozac, both of which came in 20 mg capsules but no serious safety events were reported.
- A 2006 study published in JAMA, the Journal of American Medical Association showed that long-term Prilosec use increased the risk of hip fractures in the elderly.
- In 2009, a Copenhagen-based study showed that Prilosec use may lead to a “dependency” on the medication due to a “rebound” acid like effect.
- In 2010, after a number of reports indicated an increased risk of cardiac birth defects when Prilosec and other PPIs were taken during pregnancy, the Food and Drug Administration (FDA) concluded that there was no statistically significant link. Prilosec, however, is listed as Pregnancy Category C, indicating animal studies have shown potential risk to developing embryos and fetuses.
- In 2010, the FDA also issued a consumer warning regarding PPI use, including Prilosec. The warning stated that the medication may cause an increase in bone fracture risk. This warning was based on the 2006 Copenhagen study results, along with a number of serious adverse event reports.
- In 2011, the FDA issued another warning regarding the medication’s risk of causing hypomagnesemia after long-term use. Hypomagnesemia or low magnesium levels can cause neurological, muscular, and cardiac effects.
Multiple Prilosec lawsuits may have been filed related to heart attack, birth defects, fractures and low magnesium-related medical conditions but no settlements have been reached. In addition, no action has been taken yet regarding the Prilosec-chronic kidney disease connection.
Prilosec and Chronic Kidney Disease
Prilosec and other PPI drugs have been known to increase the risk of acute kidney injury in patients with previously existing kidney damage but the JAMA article shows that Prilosec may be more harmful to greater numbers of patients.
The new study has shown that long-term use of PPIs like Prilosec increases the risk of chronic kidney disease in patients without prior kidney history. The study reviewed medical records of more than 10,500 patients and showed that the risk may be increased by 20 to 50 percent. The longer Prilosec or more frequently Prilosec was taken, the greater the risk to the patient.
Chronic Kidney Disease, also known as chronic renal failure, occurs when long-term damage is done to the kidneys, reducing the ability to filter toxins and metabolic products from the bloodstream.
CKD may have symptoms such as:
- Edema or swelling
- Fluid in lungs
- Lab electrolyte abnormalities
- Nausea and Vomiting
- Loss of Appetite
- Inability to urinate
Chronic kidney failure is progressive and will get worse over time. Symptoms of kidney failure should be reported to a medical professional.
Prilosec and Heart Attack
The studies published in PLOS One indicated that the use of Prilosec and other PPI medications can increase the risk of heart attack by up to 21 percent, even when the patient does not have a history of heart disease.
Heart attack, also known as myocardial infarction is caused by a blockage of blood supply to the heart. It may have symptoms such as:
- Sudden pain in chest, back, arm, abdomen or jaw – on one or both sides
- Feeling of pressure on chest
- Cold, clammy skin
- Shortness of breath
- Intense need to defecate
- Sudden anxiety
A heart attack can be life-threatening and any symptoms should be treated as a medical emergency.
Other Side Effects of Prilosec
All medications, including Prilosec, may cause a number of side effects. Most of these side effects are not serious but the medication may also cause serious adverse events which can be life-threatening.
Common Side Effects of Prilosec may include:
- Pain in joints or muscles
- Intestinal complaints including pain, nausea and diarrhea
- Unpleasant aftertaste
Serious adverse events may include:
- Erythema Multiforme, a potentially life-threatening rash
- Low Magnesium level with symptoms including muscle spasms, speech disorder, seizures, and arrhythmia
- Osteoporosis and bone fractures
- Abnormal blood tests
- Birth Defects
- Liver toxicity
- Cardiac effects
Serious side effects should be reported to a healthcare immediately.
Concerns about the safety of Prilosec emerged as early as 2002 and the recent study results are troubling as they have shown a risk in the general population that may worsen over time. In addition, researchers have indicated that many patients may have been prescribed PPI medications such as Prilosec without clear evidence for need and that many of these should have been discontinued.
As three of the most popular PPIs including Prilosec, are now available over-the-counter, without a doctor’s prescription, the risk of serious adverse events related to PPIs may continue to increase.
Patients who have experienced chronic kidney disease or patients who have been injured by other side effects of Prilosec may be eligible for monetary compensation for medical costs, loss of wages and pain and suffering. These patients or family members should have their case evaluated by legal experts.