Opening arguments against the manufacturer of Fosamax (alendronate sodium), Merck, started yesterday in a New Jersey federal court. This is the second lawsuit in which the plaintiff suffered a femur fracture (upper leg/thigh) from the use of the osteoporosis drug. Merck is under fire from mounting evidence that use of the drug causes bone weakening, making bone fractures and breaks, especially in the femur, more likely.
In March 2013, the first femur lawsuit against Fosamax ended in a mistrial when the plaintiff suffered an illness unrelated to the case. However, Merck is still facing thousands of additional lawsuits where prescribed patients suffered similar fractures, bone deterioration, and jaw fractures.
Arthur Santora, Merck’s Associate Vice President for Clinical Research, recently revealed that Fosamax has no fracture reduction benefit for non-osteoporotic patients. Non-osteoporotic patients make up 75-80% of all patients prescribed to the drug.
Merck is following the dangerous trend of putting profits over safety. “The pharmaceutical system in the U.S. relies upon the drug companies to accurately disclose the risks and benefits of the drugs. Because Merck did not use the labeling tools entrusted to it by the FDA, the system failed,” Tim O’Brien, attorney with the Levin, Papantonio Law Firm commented.
Fosamax was approved by the U.S. Food and Drug Administration (FDA) in 1995. The drug is commonly prescribed to treat postmenopausal osteoporosis and bone loss from cancer treatments. In 2010, the FDA updated the warning label on Fosamax to state the risks of atypical femur fractures from use of the medicine. A review by the FDA, published in the New England Journal of Medicine, suggests that there is very little benefit from taking Fosamax and other bisphosphonates over extended periods of time.
Krysta Loera is a writer and researcher with Ring of Fire.