Nexium and Prilosec
Although Nexium and Prilosec are marketed as harmless drugs to treat heartburn, the number of lawsuits filed against AstraZeneca by injured patients keeps growing every day. The two drugs are, in fact, associated with several side effects including an increased risk of chronic kidney damage, cardiovascular diseases, respiratory infections and gastric tumors.
If you or a loved one suffered from any harm or permanent damage after taking either one of these drugs, you might ask for a cash compensation. Contact us immediately; our lawyers can help you by providing free legal advice
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Why are Americans filing a lawsuit against AstraZeneca?
Prilosec (omeprazole) and Nexium (esomeprazole) are two heartburn medications to treat conditions caused by excess stomach acid. They pertain to a category of drugs that has been vastly overprescribed and abused over the course of the last years: the Proton Pump Inhibitors (PPI). AstraZeneca, the pharmaceutical company that manufactures the two drugs, marketed them without appropriately warning the public about its severe dangers. Caring only for profit, the Big Pharma obtained the approval to market esomeprazole from the U.S. Food and Drug Administration (FDA) just before its older drug’s patent expired. The newer drug is, in fact, chemically identical to omeprazole being what is known as a “mirror drug.” The company avoided a large loss of money since they kept the new drug price’s as high as possible, avoiding competition from generic medications. Prilosec was the top-selling prescription medicine in the U.S., with a yearly profit of over $4 billion in the early 2000s. Nexium’s price is about 10 times higher than other similar drugs but in order to obtain a new patent from the U.S. regulatory agency, AstraZeneca allegedly distorted the results of the studies that proved its safety and effectiveness. The former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell explained that American consumers had been artificially overcharged with a dangerous and unsafe drug that caused many serious or even lethal adverse reactions, forcing people to seek an attorney’s advice to file a litigation.
Many studies published in the last decade showed that PPIs are often inappropriately prescribed or used for excessive lengths of time. One-quarter of the patients under treatment these medications keep taking them even after their condition has been treated. Even worse, more than two-thirds of patients take these drugs without any appropriate indication. Although they are sold like common over the counter (OTC) drugs, PPIs are not devoid of dangers when used for too long. Not only the suppression of gastric acid (hypochlorhydria) may have severe consequences on human health, but newer researches found an association between the use of Nexium and life-threatening side effects including gastric tumors, heart attacks, chronic kidney disease, respiratory infections and even dementia. For a long time, the pharmaceutical companies did not include many of these serious complications on the drugs’ labels, and many people suffered from grievous injuries since nobody warned them of these dangers. Companies such as AstraZeneca should be held liable for the damage suffered by individuals who took these drugs, and filing a lawsuit to ask for compensation is the only way to seek justice in court.
Prilosec and Nexium side effects
- Gastric tumors
- Renal damage
- Chronic kidney disease (CKD)
- Heart attacks
- Respiratory infections
The dangerous consequences of using PPIs
Proton pump inhibitors are used for a wide range of gastrointestinal conditions such as heartburns, peptic ulcers, Zollinger-Ellison syndrome (ZES), and gastroesophageal reflux disease (GERD). They are also often used in combination with long-term nonsteroidal anti-inflammatory drugs (NSAIDs) treatment to prevent these medications from causing gastric bleeding. PPIs are very potent medications that act by reducing the production of hydrochloric acid in the stomach by up to 99%. Other antacid drugs such as the H2 antagonists (Tagamet, Pepcid, Zantac) are not so powerful and effective, but they’re much less dangerous as well. An adequate production of gastric acid is, in fact, crucial for our well-being. A prolonged suppression of stomach secretion increases the exposure to several strains of bacteria and microbes that usually die in the sterilizing acid medium of the gastrointestinal tract. Severe pneumonia, enteritis, and recurrent diarrhea are just some of the infections caused by Clostridium difficile and other microbes found in the food we eat. Long-term gastric acid suppression may also lead to malabsorption of many important nutrients such as Vitamin B12, causing pernicious anemia, hypomagnesemia, reduction of bone strength and increased risk of fractures. Hypochlorhydria is also linked to hypergastrinemia (excess production of a hormone called gastrin), a condition which may increase the risk of gastric tumors and other cancers.
Many patients filed a litigation after they suffered from a potentially lethal interstitial nephritis, an acute consequence of using esomeprazole. AstraZeneca never properly warned the public about this side effect, whose consequences may include permanent kidney damage, renal transplant or dialysis. A study published in the JAMA Internal Medicine journal found evidence that patients who took higher doses of this drug were associated with a 20 to 50 percent increased risk of chronic kidney disease (CKD). Another large study (the PLOS-ONE) found that PPIs may increase the risk of cardiovascular failure by up to 21 percent by damaging the internal lining of blood vessels, leading to the formation of lethal blood clots. Finally, a research published in the journal JAMA Neurology found an association between the use of these drugs and a 50 percent increased risk of dementia in elderly patients.
Additional warnings and label changes
Prilosec and Nexium’s labels have been updated by the FDA many times since they were released to the market. The regulator found that these two drugs were associated with many new risks and slowly warned the public about them over the course of the last 15 years. These warnings include:
- A drug interaction between Prilosec and the anticoagulant drug Plavix (clopidogrel), whose effectiveness may be halved with lethal consequences (2009)
- An increased risk of wrist, spine, and hip fractures (2010)
- A risk of hypomagnesemia (low magnesium levels) with long-term use of PPIs (2011)
- A new adverse reaction: microscopic colitis and Clostridium difficile-associated diarrhea (2012)
- A toxic drug interaction between Proton pump inhibitors and the antimetabolite Methotrexate (2012)
- A risk of acute interstitial nephritis as and of malabsorption leading to Vitamin B12 deficiency (2014)
Contraindications and Drug interactions
Esomeprazole and Omeprazole should be avoided during pregnancy. Nexium has been classified by the FDA as category B (no risk in animal studies, but there’s not enough data in human studies) while Prilosec has been classified as category C (animal and human studies are inadequate to exclude the risk). PPIs may interact with several drugs reducing or preventing their effects, or causing harmful toxic interactions. These medicines may also reduce the absorption of other substances by up to 50% after ingestion since they reduce the stomach acidity. If you’re under ongoing treatment with any drugs on this list, you should ask your doctor or pharmacist before taking a proton pump inhibitor.
- Anticonvulsants (Carbamazepine, Phenytoin, Mephenytoin)
- Antidepressants (Fluoxetine, Citalopram, Sertraline)
- Antifungals (Ketoconazole, Itraconazole)
- Antimetabolites (Methotrexate)
- Antivirals (Atazanavir, Ritonavir)
- Chemotherapy agents (Cyclophosphamide)
- Hormones and Contraceptives (Testosterone, Progesterone)
- Immunosuppressive agents (Cyclosporin, Mycophenolate, Tacrolimus)
- Muscle relaxants (Carisoprodol)
- Sedatives (Phenobarbital, Flunitrazepam, Diazepam)
- Blood thinners (Rivaroxaban, Warfarin, Clopidogrel)
The Nexium Antitrust Litigation
AstraZeneca has been accused of violating federal and state antitrust laws to fraudulently market their drug Nexium. In particular, according to the accusation included in the class action, the pharmaceutical company entered into reverse payment agreements with other generic manufacturers. They paid large sums of money to delay the production of less expensive generic alternatives to esomeprazole to keep their market share, actually excluding fair competition. All the class action lawsuits have been included in the Multidistrict Litigation number 2409, Lead Case Number 1:12-md-2409 overseen by Honorable Judge William G. Young.
Written by: Dr. Claudio Butticè, Pharm.D.
Visuals and Design by: Luke Kist