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Increasing evidence suggests that side effects of the osteoporosis drug Prolia may increase the risk of hip fractures, femur fractures and other bone fractures, which typically occur following minimal or low trauma events.
PROLIA LAWSUIT STATUS: As a result of the drug maker’s failure adequately warn about this risk, the potential for Prolia fracture lawsuits are being evaluated by product liability lawyers.
OVERVIEW: Prolia (denosumab) was first introduced in 2010, as a treatment for osteoporosis. It was also the first drug every approved by the FDA specifically to treat postmenopausal osteoporosis. However, early on it was linked to an increased risk of bone fractures.
According to the consumer group Public Citizen, there were concerns over Prolia side effects dating back to at least 2009; a year before it was even approved to be sold.
In 2012, Health Canada and Amgen released a Prolia bone fracture warning letter, which was designed to alert Canadian users to an increased risk of atypical femur fractures that may occur with little or no trauma to the thigh bone; the thickest, largest, and purportedly strongest, bone in the human body.
Similar warnings were placed on Prolia sold in Europe. However, Amgen has decided U.S. consumers of Prolia do not warrant the same consideration or label warnings, despite the fact it is the same drug being sold in the U.S. as is being sold in Canada and Europe…just without those same warnings about the risks of bone fractures.
In 2013, the consumer watchdog Public Citizen added Prolia to its list of pills consumers should avoid, placing the drug on its “Do Not Use” list. Public Citizen noted that not only did Prolia triple the risk of hip fractures, femur fractures and other bone problems, but there were also concerns over infections and dermatologic adverse events.
In April 2019, Public Citizen petitioned the FDA to add a black box warning to Prolia over the risk of bone fractures. It is the most stringent label warning the agency can require a drug to carry.
FIND OUT IF YOU MAY QUALIFY FOR A PROLIA LAWSUIT: As a result of the drug manufacturers’ failure to adequately warn about the risk of fracture problems, Prolia lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.
To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a Prolia lawsuit, submit information about a potential claim for review by a lawyer.