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A complaint has been filed against AstraZeneca in Texas by 35 people who allege that they suffered bone deterioration or unexpected fractures from side effects of Nexium, a popular heartburn drug.
The Nexium lawsuit was filed last week in Harris County District Court against the drug maker and a Houston-area sales manager, alleging that despite knowledge that Nexium could cause bones to deteriorate and break, the medication was sold without adequate warnings for consumers.
Among plaintiffs on the complaint are 34 women and one 9 year old boy who allege that they experienced bone problems from Nexium after using the prescription strength proton pump inhibitor (PPI) for treatment of heartburn, acid reflux, ulcers or inflammation of the esophagus.
Nexium (esomeprazole) is AstraZeneca’s best selling drug and the third best-selling medication in the world, with over $5.2 billion in sales in 2008. The medication works by reducing acid in the stomach, but the complaint alleges that Nexium prevents calcium absorption, which can cause bones to deteriorate and eventually fracture or break.
According to the complaint, Nexium caused the fracture of various bones among the different plaintiffs, including the foot, ankle, leg, arm, hand, knee and fractured vertebrae in the back or neck. Several of the plaintiffs suffered a Nexium fracture with no apparent trauma or fall, resulting in surgery or permanent injury in many cases.
Bone density scans revealed bone deterioration for many of the women and some have been diagnosed with osteoporosis, despite no family history of the condition.
In May 2010, the FDA warned that there may be an increased risk of bone fractures from Nexium and other similar medications, which are part of a class of drugs known as proton pump inhibitors (PPIs).
The FDA required an update to the warning label about the risk of fractures from Nexium, and similar warnings were added to other drugs in the class, including Aciphex, Prevacid, Prilosec, Protonix, Vimovo and Zegerid.
In March 2011, the FDA updated its Nexium fracture warning, saying that the bone fractures appeared to be linked to high doses over a long period of time. Over-the-counter versions of the drugs did not appear to be affected.
According to allegations in the lawsuit over Nexium, studies as early as 2006 suggested that the drug may interfere with the body’s ability to absorb calcium, reducing hydrochloric acid in the stomach, which speeds up bone loss and leads to an increased number of fractures. Plaintiffs point to at least six studies that have found the risk of fractures significantly increased for patients over 50 years old who took a prescription strength proton pump inhibitor like Nexium, or took any PPI for more than year.
A similar Nexium fracture lawsuit was filed last month in federal court in Texas by a woman fro Ohio, who alleged that she suffered a broken leg from Nexium bone deterioration.