We’ve long been writing about links with proton pump inhibitors (PPIs), such as <"https://www.yourlawyer.com/topics/overview/nexium">Nexium, and bisphosphonates, such as <"https://www.yourlawyer.com/articles/read/14517">Fosamax, to increased risks of bone fractures. PPIs reduce stomach acid and are typically taken for heartburn and acid reflux. Bisphosphonates are osteoporosis medications.
Now, said Consumer Affairs, a woman in Ohio has alleged that taking AstraZeneca’s Nexium for long periods resulted in severe bone degradation and that, on July 10 2005, she “was simply walking when a bone in her leg suddenly broke in half.” In June 2007, the same bone broke again; three bones in her ankle also shattered, said Consumer Affairs. Ginny Begin, 58, said she suffered “severe bone deterioration†and a number of fractures after taking Nexium, wrote Consumer Affairs. Begin’s lawsuit alleges that while Nexium does reduce stomach acids, it also stops calcium absorption, which leads to bone deterioration and fractures. Begin took Nexium daily from 2003 to 2011.
The suit also noted that in 2010, the U.S. Food and Drug Administration (FDA) issued a safety alert warning over Nexium’s osteoporosis and fracture risks and said the fracture risk was realized as far back as 2006. According to the lawsuit, studies found the fracture risk to be more pronounced in patients over the age of 50. “Despite knowing Nexium causes bones to deteriorate and break, Defendants marketed and sold Nexium without warning consumers of the significant risks of bone deterioration and fractures,” the suit charges, quoted Consumer Affairs.
In Louisiana’s Lafourche Parish, Josephine P. Naccio filed a lawsuit against Merck (Merck Sharp & Dohme Corp. f/k/a Merck & Co., Inc.), Watson Pharmaceuticals Inc., and Barr Laboratories in federal court for “over-promotion†of Fosamax, said the Louisiana Record. Naccio was prescribed Fosamax long-term for osteoporosis and, now alleges, she suffered an “unexplained femur fracture,†said the Louisiana Record. Naccio stated she never would have taken Fosamax if she was aware of its long-term risks.
Merck is also accused of hiding “unreasonably dangerous risks” of femur fractures and of neglecting to perform post-marketing surveillance, with causes of action such as “composition defect, design defect, inadequate warning, breach of express warranty, redhibition, and breach of express and implied warranty of fitness for ordinary use,†said the Louisiana Record. Redhibition, is a civil action available under Louisiana law against makers and sellers of defective products.
Last May, the FDA announced it was revising safety labeling for both over-the-counter and prescription PPIs to warn that they might be associated with a higher risk of hip, wrist, and spine factures. Some studies found that those at greatest risk for these fractures received high doses of PPIs or used them for one year or more.
Bisphosphonates have also been linked to fractures and other bone problems. Last October, the FDA added warnings to the labels of bisphosphonates, such as Fosamax, after studies showed long-term use of the drugs could be linked to a rare type of thigh fracture. The use of Fosamax and other bisphosphonates has also been associated with osteonecrosis of the jaw (ONJ), or dead jaw syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the FDA ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.
