Nexium (generic: esomeprazole, esomeprazole magnesium), often used to treat common heartburn and more serious conditions such as gastroesophageal reflux disease, has been linked to increased risks of bone and hip fractures in middle-aged adults. More recently, Nexium and other proton pump inhibitors have also been connected to low magnesium levels in patients, which may cause muscle spasm, irregular heartbeat and seizures.
UPDATE: FDA Updates Warning Labels on Nexium and Heartburn Drugs
November 6, 2014 — The FDA will add new warnings about side effects of heartburn drugs like Nexium, but they are stopping short of a “Black Box” warning about bone fractures and pneumonia. Click here to read more.
July 12, 2013 — Researchers have published a study linking all drugs in the PPI class, including Nexium, to a potential risk of heart problems. Click here to read more.
December 10, 2012 — Nearly 40 Nexium bone fracture lawsuits and class-actions have been centralized in the U.S. District Court for the Central District of California before Judge Dale S. Fisher. Click here to read more.
January 31, 2012: The British Medical Journal has published the results of a study which found that many popular heartburn medications may increase the risk of hip fractures, especially in older women. The researchers found that hip fractures were linked to popular heartburn medications known as Proton-Pump Inhibitors (including Prilosec, Nexium, Prevacid, Aciphex, and more). Post-menopausal women who took one of these medications regularly for at least two years were 35% more likely to suffer a hip fracture. The risk was even higher for women who smoked.
Nexium: An Overview
Manufactured by AstraZeneca Pharmaceuticals and approved by the FDA in February of 2001, Nexium belongs to a group of drugs called proton pump inhibitors (PPIs). Nexium and other PPIs decrease the amount of acid produced in the stomach and are used to treat conditions like gastroesophageal reflux disease (GERD or acid reflux disease), a condition where the backward flow of acid from the stomach causes heartburn and possible injury to the esophagus (tube between throat and stomach). While this is the most common use for Nexium, it may also be used to treat other conditions like Zollinger-Ellison syndrome and may be used in combination with antibiotics to decrease the chances for ulcers in nonsteroidal anti-inflammatory drug users.
However, in 2010, the FDA found that patients who had used Nexium in high doses for more than a year may be at risk of hip, wrist and spine fractures. Patients over the age of 50 are at the greatest risk of developing fractures.
Furthermore, the FDA recently announced PPIs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse side effects including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures).
Due to the severity of these side effects, Nexium patients may want to contact a Nexium lawyer at The Schmidt Firm, PLLC for a free case evaluation to discuss the potential for a Nexium lawsuit.
Nexium Side Effects
These side effects are the most severe associated with Nexium and other PPI drugs:
- Hip fractures
- Wrist fractures
- Spine fractures
- Hypomagnesemia (low serum magnesium levels)
- Tetany (muscle spasms)
- Arrhythmias (irregular heartbeats)
- Fast heartbeat
- Chest pain
- Dark urine
Less serious side effects may include:
- Stomach pain
- Dry mouth
Nexium and Bone Fractures
After reviewing several studies linking PPIs to fractures in May 2010, the Food and Drug Administration (FDA) warned doctors and consumers:
“Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them longer (a year or more)..”
In a 2006 study published by the Journal of the American Medical Association, 135,000 people at least 50 years or older were studied. Patients who took PPIs for longer than one year at a high dosage were found to be 2.65 times more likely to break a hip. Additionally, the risk of fracture increased with the length of time PPIs were taken.
Because of the study’s findings, the FDA has said that all PPIs will now carry a new warning label about the potential risk of bone fractures. In March 2011, The FDA determined over-the-counter (OTC) PPI medications do not need this warning. They concluded that fracture risk was not likely for short-term (14 days or less) and low doses.
Bone fractures occur because of a lack of calcium in the body, due to PPI usage. When the amount of stomach acid is reduced, the body undergoes a health decline because of a decrease in the amount of nutrients absorbed. For example, low stomach acid limits the body’s ability to absorb calcium, which can lead to a softening of the bones.
Nexium and Low Magnesium Levels
In March 2011, the FDA issued a drug safety alert suggesting that Nexium and other PPIs may cause low serum magnesium levels (hypomagnesemia) if taken for a prolonged period of time — usually longer than one year, although there were cases of patients developing hypomagnesemia after only 3 months of usage. Lower magnesium levels may lead to serious health issues including muscle spasm, irregular heartbeat and seizures. The FDA identified at least 50 cases of hypomagnesemia, likely caused by heartburn medications like Nexium.
The FDA announced that the information about the possible risk of low serum magnesium levels will be added to the Warning and Precautions section of all prescription PPIs labels, except for over-the-counter versions of the drugs, which are not affected.
The condition cannot be easily treated, even with use of magnesium supplements. In some cases, clients needed to be taken off of PPIs for magnesium levels to return to normal.