AstraZeneca’s widely-prescribed heartburn drug Nexium (esomeprazole magnesium) has recently been linked to bone fractures and bone breaks, particularly among users who have taken the drug over an extended period of time. In May 2010, the U.S. Food & Drug Administration (FDA) required that labels of Nexium and other proton pump inhibitor (PPI) drugs be updated to include information about this risk. Nexium fractures have been reported to involve a number of different bones including the ribs, ankles, feet, hip, wrist and spine.
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.
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” said Dr. Joyce Korvick, FDA’s Division of Gastroenterology Products deputy director for safety. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
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. According to the lawsuit, “[A]s early as 2006, studies found PPI’s, by reducing hydrochloric acid in the stomach, interfere with the body’s ability to absorb calcium, thus speeding up bone loss and leading to an increased number of fractures. In total, six studies have found the risk of fracture significantly increased for those patients over 50 years of age who took a prescription-strength PPI, like Nexium, or who took any PPI regularly for more than one year. Specifically, use of PPI’s increases the risk of fractures in women up to 34 percent.”