AstraZeneca’s widely-prescribed heartburn medication Nexium (esomeprazole magnesium) has recently been linked to bone fractures and bone breaks, particularly among users who have taken the drug for a long period of time. In May 2010, the U.S. Food & Drug Administration (FDA) required that labels of Nexium and other proton pump inhibitors (PPIs) be updated to include information about this risk. Recent studies have also linked PPI heartburn medications to chronic kidney disease (CKD), renal failure and nephritis (inflammation of the kidneys).
First approved by the FDA in February 2001, Nexium is a proton pump inhibitor drug used to treat the symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid. It is AstraZeneca’s best-selling drug, as well as the third best-selling medication in the world, generating over $5.2 billion in sales in 2008 alone. Esomeprazole, the active ingredient in Nexium, is now manufactured by several companies under the brand names:
Nexium Bone Fractures
It has been theorized that Nexium has the potential to cause bone fractures because it reduces acid in the stomach, which in turn lowers the amount of calcium dissolved and absorbed into the body. Nexium also interferes with the body’s ability to break down and rebuild bone by manipulating the acid production of osteoclasts. Additionally, the reduction of B-12 by raising homocysteine may make the bones more fragile and prone to fractures or breaks.
FDA Warning on Nexium
The FDA’s review of several long-term studies which found an increased risk of hip, wrist, and spine fractures in PPIs users prompted the administration in May 2010 to revise labeling requirements for the drugs. The research indicated that these fractures occurred more often in patients who used PPIs like Nexium for more than one year at a higher dose. Then in 2011, researchers reiterated the fact that the risk of bone fractures greatly increased when using PPIs. Scientists found that PPI users who smoked had a 51% increased risk of suffering a hip fracture, and concluded that the longer the duration of use, the greater the risk of a fracture.
Nexium Bone Fracture Lawsuit Filed in Texas
In April 2011, a lawsuit was filed on behalf of an Ohio woman who suffered severe bone deterioration and broken bones after taking Nexium. Filed in the U.S. District Court in Houston, the complaint alleges that 58-year-old Ginny Begin suffered serious bone deterioration after taking Nexium on a daily basis from 2003 until early 2011.
PPI Heartburn Medications May Increase Risk of Kidney Disease, Study Finds
In addition to increasing the risk of bone fractures and breaks, Nexium and other PPIs may cause chronic kidney disease (CKD) and other kidney damage in some users. According to a Jan. 2016 study published in JAMA Internal Medicine, PPI users had a 45% increased risk of developing CKD compared to non-users.