When the Food and Drug Administration (FDA) approved the drug denosumab (PROLIA) for treating postmenopausal osteoporosis in 2010, it was the first time a drug of its kind was to be used for this purpose. Despite the FDA’s ultimate approval of the drug, serious safety concerns had arisen prior to an August 2009 FDA advisory committee meeting discussing issues of safety and efficacy. These safety concerns led denosumab to be categorized as Do Not Use on WorstPills.org.
Denosumab interferes with the body’s important processes of bone metabolism and immune function. One result is that its use may lead to atypical fractures (breaks in the bone that occur spontaneously with little to no trauma, unlike breaks involving major trauma, such as a fall). In November 2012, the drug company issued the first of two warning letters to health care professionals, informing them of the risks of atypical fractures with use of the drug.