Nexium is an FDA-approved stomach acid pill used for the treatment of conditions such as acid reflux disease, stomach and duodenal ulcers, and the Zollinger-Ellison syndrome. However, medical studies have indicated adverse side effects of Nexium when taken for the long-term, including kidney disease and renal failure. Taking that into consideration, the FDA insisted users and doctors weigh the known benefits against the potential risks while deciding to use such a prescription drug.
This article will integrate the science behind one of the most popular prescription drugs Nexium (generic name: esomeprazole), in particular, what it treats and the associated side effects. Next, this article will include various medical studies and FDA warnings, which indicate an association of Nexium to kidney injuries and other complications, such as heart attack, stomach inflection, and dementia. Finally, this article will conclude with Nexium lawsuits that can help you recover compensation from the drug’s manufacturer for the damages caused while using Nexium.
Nexium: The Little Purple Pill
One of the most prescribed drugs used in the U.S., Nexium was launched by AstraZeneca in 2001. Nexium is a member of a class of powerful prescription drugs called proton pump inhibitors (or PPIs).
Right from its launch, Nexium gained immense popularity as a prescription drug, which also bagged the manufacturer over $14 billion by the year 2005. In 2008, it earned more than $13 billion in sales as one of the most popular heartburn prescription medications. Nexium24HR, an FDA-approved over-the-counter formulation, is also available.
Today, Nexium is offered as a prescription and over-the-counter drug to treat gastroesophageal reflux disease (GERD) and acid reflux.
An estimated 15 million people take prescription PPIs in the United States, and those taking over-the-counter PPIs can take this score only a notch higher. Apart from Nexium, other popular PPI medications in this class include Prilosec, Prevacid, Aciphex, and Protonix.
Touted in a myriad of TV commercials and online advertisements, this “Little Purple Pill” was aggressively marketed as the logical medicine for heartburn-prone individuals with a powerful message that clearly stated that Nexium can fix all your stomach acid worries (while completely ignoring the associated risks).
Nexium is actually just a reformulated version of Prilosec (AstraZeneca’s first PPI), the American patent which expired in 2001. It was around the same time when AstraZeneca launched its new medication drug with the name “Nexium” to replace Prilosec as its choice of PPI. The two drugs—Nexium and Prilosec—were mirror images of one another and in spite of the similarities between them, the U.S. FDA gave approval for using Nexium as a prescribed medicine in February 2001. AstraZeneca, once again, was able to make loads of money off its prior drug formula, although now under a new brand name. With tremendous marketing and promotion, Nexium became the third best-selling drug of the past quarter-century.
Nexium: How it Works and Potential Uses
Nexium works by turning the acid pumps off in your stomach’s acid-producing cells, which are responsible for the production of gastric acid. It blocks an enzyme in the stomach wall to reduce stomach acid secretion.
Nexium is commonly prescribed by doctors to relieve the symptoms of problems related to the production of excess stomach acid, including peptic ulcers and gastroesophageal reflux disease (or GERD). GERD is a chronic condition that occurs when acid from your stomach frequently flows back into the esophagus, causing acid indigestion and heartburn.
Nexium, as a prescription medication, is frequently used to prevent or treat the following medical conditions:
- Gastrointestinal ulcers (associated with Chron’s disease)
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis
- Zollinger-Ellison Syndrome
- Peptic ulcers
- Gastric ulcers
Since these medical conditions are common, proton pump inhibitors like Nexium, are among the most prescribed medications across the world. The popularity behind the Nexium drug is also its wide availability and relatively lower price than other proton pump inhibitor drugs. It can be consumed orally, by injection, as well as in the pill form. Moreover, versions of Nexium are available over-the-counter, without the patient needing a prescription as they were considered safe.
Adverse Effects of Nexium
A powerful PPI like Nexium might seem like a miracle drug to some people at the time they are introduced to it. A lot of doctors and physicians also prescribed this drug to millions of their patients without considering the potential risks. However, the use of Nexium has indicated a range of side effects that contribute to health threats in millions of people. The side effects may vary from mild to moderate, and some of them go away with time.
The common side effects in people using Nexium may include:
- Loss of appetite
- Abdominal pain
- Dry mouth
- Muscle pain
- Leg cramps
Higher doses and longer dependence on the drug may put people at more risk.
Serious Side Effects of Using Nexium
Medical studies have associated Nexium and other PPI medicines to a wide range of health risks, mostly due to its side effects, extending from kidney damage to cancer. The severe side effects may be life-threatening and should be dealt with as an emergency. The side effects were recognized when doctors, scientists, and epidemiologists begin to notice trends in patients who used Nexium (or esomeprazole) drug and their safety concerns were then also backed by overwhelming scientific evidence, highlighting the dangers of PPIs like Nexium. Nexium and other PPIs have been reported to have a high risk of kidney injuries, including acute interstitial nephritis, kidney/renal failure, and chronic kidney disease (CSK).
Often used inappropriately, some research studies suggest that Nexium and other PPIs are suitable for short-term use only. The short course of treatment may range from 4 to 8 weeks. However, many patients are reported to taking these prescription drugs for more extended periods, which exposes them to the harmful side effects and potential complications with taking Nexium. The longer a person uses this drug, the higher the risk.
Kidney Inflammation – Acute interstitial nephritis
Nexium may risk patients of a dangerous condition called acute interstitial nephritis—a type of kidney inflammation. If not diagnosed and treated timely, this can lead to kidney disease and renal failure.
In 1994, Nexium’s manufacturer AstraZeneca revealed that around 15 incidents of kidney inflammation associated with Nexium had been reported across the world. Later in 2005, two more incidents were reported. In one incident, an older man of age 63 had developed nephritis after taking Nexium for just three weeks. The second instance involved a patient who had to undergo dialysis for taking Nexium for a prolonged period.
In 2014, the FDA instructed AstraZeneca to add new safety information about nephritis to the labels of all prescription PPIs, including Nexium, as part of a petition filed by the Public Citizen. The new safety information regarding potential risks of diseases added to PPI labels included:
- Vitamin B12 deficiency
- Clostridium difficile-associated diarrhea
- Recommended length of treatment for gastroesophageal reflux disease (GERD)
- Acute interstitial nephritis (kidney inflammation)
- Drug interactions with mycophenolate mofetil and methotrexate
- Drug interactions with Plavix, an anti-clotting drug that is dangerously less effective in patients on heartburn drugs
However, the Public Citizen petition with the U.S. FDA also demanded to put Black Box warnings on all proton pump inhibitors to warn patients and doctors alike about their severe side effects, such as bone fracture risk, infection risk, severe magnesium deficiency, and risk of rebound acid hypersecretion.
The American Journal of Gastroenterology reported results of a clinical trial where they confirmed that patients who take Nexium to treat symptoms associated with heartburn have shown to end up with worse heartburn symptoms when they try to discontinue taking the drug abruptly.
In April 2015, another study was published in CMAJ Open that linked PPIs to a threefold increase in the risk of developing acute interstitial nephritis and a higher risk of acute kidney injury in older adults as compared to their peers who did not take the medicines. The seniors are also more likely to develop kidney disease or failure as a result of nephritis.
Symptoms of nephritis can occur at any time during the use of Nexium, and there is a 50 percent probability that it will develop kidney failure. Around 15 percent of hospitalizations as a result of renal failure happen due to symptoms of nephritis. The common signs and symptoms of Nexium may include blood in urine, reduced urination, malaise, nausea, poor appetite, coma, swelling owing to fluid retention, fatigue, and weakness.
The Journal of the American Society of Nephrology published a study in April 2016 suggested that patients who use medications are 96 percent more likely to suffer from kidney failure and 28 percent have a higher probability of developing chronic kidney disease. The study also specified that the dosage and duration of use affect the overall risk.
Chronic Kidney Disease (CKD)
Studies on long-term use of Nexium by patients have shown an increased risk of chronic kidney disease, which may also lead to kidney failure, dialysis, and even need for a kidney transplant in some situations. In 2016, two studies were carried out, which indicated possible ties between chronic kidney disease and proton pump inhibitors, such as Nexium. In one study, medical records of over 173,000 subjects who were prescribed a PPI drug were compared to more than 20,000 who were given a different class of heartburn drugs, known as H2-blockers. Followed up for five years, the study revealed that 15 percent of the patients using PPIs got diagnosed with chronic kidney disease in comparison to 11 percent of people using other medications. Those with an intake of the drugs for a longer period (one to two years) were at higher risk of kidney failure and other kidney-related problems.
A similar conclusion was reached by another study published in JAMA Internal Medicine. Research with 10,482 participants, followed for an average of 13.9 years, was conducted to evaluate rates of kidney disease among PPI users and H2 blockers. The results suggested that those taking PPIs were associated with a 50 percent higher risk of developing chronic kidney disease.
Chronic kidney disease or failure is a gradually progressive disease, where the signs and symptoms are generally not noticeable until the condition has relatively advanced, and the damage has become irreversible. Common signs and symptoms of chronic kidney disease may include nausea, vomiting, loss of appetite, sleep problems, fatigue and weakness, shortness of breath, chest pain, changes in urine output, and others. There is no cure for chronic kidney disease.
Although it is unclear how Nexium affects the kidneys, the extended use of Nexium has been found to cause severe kidney problems like Acute Interstitial Nephritis (AIN). This condition—a severe and sudden inflammation of the kidneys—has already been identified as a potential complication of using proton pump inhibitors. There is a possibility that when this condition is undiagnosed, it could sooner or later lead to chronic kidney disease in some patients on Nexium prescription.
Inadequate magnesium levels can also affect kidney function, and studies suggest that PPIs like Nexium can cause low levels of magnesium in the body, thus causing kidney disease.
Patients who have been prescribed Nexium or those buying it over-the-counter must make sure that they are not allergic to esomeprazole magnesium or any of its ingredients. In fact, patients who are known to have any allergy with PPI should not take Nexium. Do not change your dosage or stop Nexium without your doctor’s advice.
Other Nexium Complications
Apart from kidney issues, studies have shown Nexium and other PPIs to have some serious side effects as well. Here are some such complications discussed briefly:
In June 2015, PLOS One published a research study where medical records of nearly 3 million patients who were using proton pump inhibitors were taken into consideration and analyzed for a possible connection between Nexium and heart attacks. The research results suggested that such patients have a 16-21 percent higher risk of myocardial infarction, commonly known as heart attack, whether or not they have any prior history of cardiovascular disease.
Risk of Dementia
Dementia is considered as a group of conditions characterized by impairment of at least two brain functions, such as loss of memory and reasoning skills, severe enough to interfere in the patient’s daily life. According to a study published in JAMA Neurology in April 2016, the overuse of heartburn medications, such as Nexium, could develop an increased risk of dementia in seniors, aged 75 or older. This analysis suggested that regular users of PPI were at a 44 percent increased risk of suffering from dementia as compared to those who were not on prescription medications.
Blood Vessel Damage
Concerns over long-term exposure of Nexium surfaced once again when a study published in May 2016 in the Circulation Research raised questions about faster aging of blood vessels due to PPIs like Nexium. The results of the study indicated that Nexium could impair the production of acid by lysosomes, which clear waste build-up from the cells. This waste build-up caused the endothelial cells to age rapidly, thus interfering with its ability to protect blood vessels. Such damage was not seen in endothelial cells when exposed to H2 blockers—a class of heartburn drugs that includes Tagamet and Zantac.
With rising alleged side effects on kidney, another study, of nearly 565,000 adults, showed a higher risk of dangerous stomach infections with C. difficile and Campylobacter bacteria. Published on January 2017 by the British Journal of Clinical Pharmacology, this research report suggested that the reduced acid secretion due to taking Nexium and other PPIs could make people more vulnerable to gut bacteria, resulting in an increased risk of gastrointestinal infections.
Risks to Heart Disease Patients
The health risks of long-term use of proton pump inhibitors to heart disease patients were suggested by a study published in the International Journal of Cardiology in the issue of June 2016. In a study that involved data from 604 patients revealed that there was a high prevalence of anemia in patients who were using PPIs, such as Nexium, Prevacid, or Prilosec, as compared to those who did not take those medications. Prolonged use of Nexium was also connected with worsening of metabolic profile, partially as a consequence of decreased utilization of ACE-inhibitors and stains.
Nexium Drug Interactions
Patients who already take PPIs should avoid or limit exposure to certain foods and medicines due to potentially harmful drug interactions. All medications and supplement intake should be discussed with a doctor before taking PPIs, like Nexium. Your doctor must be aware of all the medication you are taking before prescribing Nexium to you. A doctor may reduce the dosage or suggest a PPI alternative in such cases.
Drug interaction studies have shown that Nexium is known to interact with a total of 149 drugs, which include 30 minor, 106 moderate, and 13 major drug interactions.
Nexium is a CYP2C19 inhibitor and may affect medication drugs that rely on this enzyme. Some of the drugs that interact with Nexium include Lanoxin (digoxin), Valium (diazepam), Plavix (clopidogrel), Nizoral (ketoconazole), Viracept (nelfinavir), Invirase (saquinavir), Pletal (cilostazol) and others.
Nexium: FDA Safety Warnings
The U.S. Food and Drug Administration (FDA) issues safety warnings and alerts when a drug causes negative side effects. Regarding Nexium, FDA has issued some warnings about Nexium since 2010.
In 2010, FDA issued a warning that reported an increased risk of osteoporosis-related fractures of the spine, wrists, and hip, especially in patients above age 50 with proton pump inhibitor use as well as among patients taking higher doses of Nexium for a year or more.
In 2011, a warning by FDA cautioned users that prolonged use of PPIs like Nexium had been linked with hypomagnesemia, commonly referred to as low serum magnesium levels. Low levels of magnesium in the blood can result in arrhythmias, seizures, and muscle spasm if you are taking Nexium for at least three months, and doctor help is recommended.
In 2012, the FDA released a safety communication that states the possible connection between the use of Nexium and other PPIs with a higher risk of Clostridium difficile-associated diarrhea (CDAD).
In 2014, FDA warned about a vitamin B12 deficiency that may lead to memory loss and acute interstitial nephritis, which if left untreated may lead to kidney/renal failure. Both of these serious medical conditions were associated with long-term use of Nexium and other similar PPIs. Based on animal data, the FDA warned Nexium users of potential fetal harm in humans.
In 2015, for the first time, the FDA issued an official warning regarding the side effects of proton pump inhibitors, including Nexium, on the kidney.
In 2016, FDA issued a warning about lupus erythematosus events and determined the addition of information about systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) to the labels, which had been reported in patients taking PPIs, including Nexium.
Several lawsuits have been filed nationwide alleging Nexium’s manufacturer, AstraZeneca, responsible for the serious damages caused to patients as a consequence of long-term (one year or more) Nexium use. The lawsuits asserted the fact that the makers and marketers of Nexium did not disclose or fail to warn doctors and patients alike about the negative impacts and side effects that come with taking Nexium, and that affected potential patients’ ability to make an informed decision about the choice of drug. The non-disclosure of possible side effects and complications led to several product liability cases against AstraZeneca.
Find a Nexium Mass Tort Near Me
Drug manufacturers should take responsibility for their negligence and compensate you for the damages caused, including past and future medical expenses, lost wages or other income, emotional distress, physical pain and disability, and mental suffering. The plaintiffs or their family members may be eligible for compensation, but prompt action is suggested to serve their interests.
If you or someone you care about is adversely harmed from taking Nexium and suffered from severe side effects, you must seek assistance from a dedicated law firm with an experience of successfully presenting mass tort claims for dangerous drugs like Nexium. A dedicated Nexium Mass Tort lawyer can determine if the makers and distributors of Nexium might be held responsible for your losses. Consumer Alert Now can help you connect with such dedicated and experienced attorneys who can offer a free review of your case and work with other litigators around the country to help you recover fair compensation. Get in touch with us today at 800-511-0747 to talk about any possible Mass Tort lawsuits which you may file indicating the side effects of Nexium or any other dangerous drug that you suffered.