Nexium (esomeprazole) is a member of the PPI group of drugs, meaning it is used to reduce acid in the stomach that can cause heartburn or acid reflux disease. However, recent research suggests that patients over the age of 50 who use Nexium for one year or more and at a high dose (above over-the-counter doses) are at an increased risk of hip, wrist and spine fractures.
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 announced the results of a new study that has found a link between Nexium and other popular heartburn medications and a higher risk of hip fractures. The risk of suffering a hip fracture was 35% higher for women who took Nexium or other Proton Pump Inhibitor heartburn medication regularly for at least two years. Women who smoked had an even higher risk.
Nexium: An Overview
Nexium (esomeprazole, esomeprazole magnesium) belongs to a group of drugs known as proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach in order to treat acid reflux disease and common heartburn conditions. PPIs are available over-the-counter and by prescription.
Nexium may also be used to treat 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 throat. It is also used to prevent gastic ulcers and in treatment of conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome.
Nexium is manufactured by AstraZeneca Pharmaceuticals and was approved by the FDA in February 2001.
In May 2010, the FDA found Nexium and PPIs may cause a possible increased risk of fractures of the hip, wrist and spine — especially in older patients who have used it for a year or more and/or at high, prescription-level doses.The FDA concluded that short-term, low dose PPI use is unlikely to result in osteoporosis or bone fracture.
The FDA is revising the labels on prescription PPIs to include information regarding the possible risk of fractures of the hip, wrist and spine. The new safety information is based on FDA review of several studies that reported an increased risk of bone fractures with PPI use.
Doctors and PPI users should be aware of the possible risk of fractures, as well as weigh the known benefits of the drugs against the potential risks when deciding whether or not to use them.
Side Effects of Nexium
The FDA has linked Nexium to fractures in the:
Other side effects of Nexium include:
- Hypomagnesemia (low serum magnesium levels), which can cause muscle spasms, irregular heartbeat, fast heartbeat, seizures, tremors, chest pain, dark urine
- Stomach pain
- Dry Mouth
FDA Warning and Actions
Of seven studies reviewed by the FDA, six reported an increased risk of hip, wrist and spine fractures with the use of PPIs. The emergence of fractures varies among studies with one study reporting an increase in fractures after just one year of use, while another study found an increase after 5 to 7 years of PPI use. While the FDA admits there are limitations to these studies, it acknowledges there is a possible increased risk of fracture in patients using PPIs.
The studies mostly evaluated individuals over the age of 50, where the majority of the increased risk of fracture was observed. Additionally, patients who received high doses and used them for one year or more were also at the greatest risk.
Said the FDA:
“In summary, the available data, including findings from several epidemiological studies, suggest a possible increased risk of fractures of the hip, wrist and spine in patients using proton pump inhibitors. The data suggest that the increased risk may be dependent upon dose, duration of use, or both. At the present time, there is uncertainty about the magnitude of this risk. In light of this uncertainty, when prescribing proton pump inhibitors, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
Prescription PPIs include:
Over-the-counter PPIs include:
- Prilosec OTC
- Zegerid OTC
- Prevacid 24HR
Unlike prescription PPIs, over-the-counter (OTC) PPIs are marketed at low doses and are only intended for a 14 day treatment, up to 3 times per year. At this short-term, low dose, the FDA believes hip, wrist and spine fracture is unlikely.
However, the FDA acknowledges that consumers, either on their own or on doctor recommendation, may take these OTC products for periods of time longer than the 14 days. Patients should be aware of the risk of fracture if they are using OTC PPIs at higher doses or for longer periods of time.
Nexium and Low Magnesium Levels
In March 2011, the FDA issued a Drug Safety Communication suggesting Nexium and other drugs belonging to the PPI group may cause hypomagnesemia, characterized by low serum magnesium levels, if taken for a prolonged period — usually over one year, but some cases developed after only 3 months. The FDA has identified at least 50 cases of hypomagnesemia, likely caused by heartburn medications like Nexium.
Hypomagnesemia may be serious because it can lead to tetany (muscle spasms), irregular heartbeats, fast heartbeat, seizures, tremors, chest pain, and dark urine. Hypomagnesemia may be difficult to treat, even with the use of magnesium supplements. Some patients needed to be taken off of their PPI medication for their magnesium levels to return to normal.