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Amid continuing concerns about the link between Prolia and bone fractures, the findings of a new study suggests that the risk of problems with Prolia are similar to those seen in prior years with the other osteoporosis drug Fosamax, where users report suffering hip fractures and other bone fractures with little or no trauma.
In a study published this month in the medical journal JAMA Network Open, researchers from Denmark compared the three-year incidence of hip fractures and other types of fractures between Prolia and Fosamax, finding that the rate of problems was comparable between the two bone drugs.
Prolia (denosumab) was introduced by Amgen in 2010, and was the first drug approved by the FDA for the treatment of postmenopausal osteoporosis.
Fosamax (Alendronate) is an older osteoporosis drug introduced in 1995, which has been linked to an increased risk of atypical bone fractures, typically involving falls from standing height or less, resulting in the FDA requiring updated warnings about the risk of sudden bone fractures in 2010.
In 2013, the prominent consumer watchdog group Public Citizen raised concerns that the side effects of Prolia may increase the risk of low-trauma fractures, indicating that the drug appears to interfere with bone metabolism and the body’s immune system, resulting in breaks that may occur in situations that would not typically result in such an injury.
Although Amgen issued warnings about the Prolia bone fracture problems in Canada as early as 2012, concerns have been raised that insufficient warnings are still being provided in the United States.
Earlier this month, Public Citizen filed a petition with the FDA calling for the agency to require a “black box” Prolia fracture warning, which would be the strongest warning the drug maker could be required to add to the label.
In this new report, researchers conducted a population-based cohort-study using data on more than 92,000 individuals 50 years or older in Denmark from May 2010 to December 2017.
According to the findings, the three-year cumulative incidence of hip fracture with Prolia was 3.7%, compared to 3.1% with Fosamax, an older osteoporosis drug. The study also found that the three-year cumulative incidence of any fracture was 9% for both.
“In this nationwide cohort study based on routinely collected data in Denmark, treatment with denosumab and alendronate were associated with similar risks of hip and any fracture over a 3-year period,” the researchers concluded. “Sex, age, and fracture history were not associated with patients’ risk.”
Amgen has acknowledged that there users face an increased risk of fractures after stopping the drug, but company has indicated that it believes the benefits to patients outweigh the risks. However, Public Citizen’s petition says the science is pointing to those risks being bigger than first believed.
As more consumer learns that problems suffered in recent years may have been avoided with stronger warnings, it appears likely that Amgen may face Prolia bone fracture lawsuits, raising allegations similar to those presented in several thousands Fosamax lawsuits in prior years.