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An Ohio woman has filed a lawsuit against AstraZeneca, alleging that she suffered bone deterioration and fractures from Nexium, a popular acid reflux drug.
The Nexium bone fracture lawsuit was filed on April 19 by Ginny Begin, 58, of Toledo, in the U.S. District Court for the Southern District of Texas. According to the complaint, Begin suffered a broken leg in July 2005 and again in 2007 due to bone deterioration while on Nexium.
Begin took Nexium daily from 2003 until earlier this year. The lawsuit claims that the side effects of Nexium caused her bones to degenerate, resulting in multiple breaks.
In May 2010, the FDA warned that there may be an increased risk of bone fracture from heartburn drugs like Nexium, which are part of a class of medications known as proton pump inhibitors (PPIs). The FDA required an update to the warning label about the risk of Nexium fractures, and similar warnings were added to other drugs in the class, including Aciphex, Prevacid, Prilosec, Protonix, Vimovo and Zegerid.
Last month, the agency updated its 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.
The prescription drugs pull in about $14 billion in U.S. sales each year, and many are prescribed for indigestion and heart burn, although with the exception of Prilosec, they are only approved for treatment of ulcers, acid reflux disease and erosive esophagitis.
There were about 119 million prescriptions for proton pump inhibitors in the U.S. last year. Some medical experts estimate that as many as 69% of proton pump inhibitor prescriptions were written for “off-label” uses, which have not been approved as safe and effective by the FDA.
Begin’s Nexium lawsuit accuses AstraZeneca of failing to warn doctors and patients of the potential risk of bone fracture side effects, alleging that the company knew or should have known about the health risks.
The complaint states that Begin’s leg and ankle injuries have never fully healed and seeks damages as a result of AstraZeneca’s negligence and marketing a defective drug.