Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Romosozumab

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In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Amgen’s new drug application for romosozumab for treatment of osteoporosis in postmenopausal women at high risk for fracture because of clinical trial data linking the drug to an increased risk of serious adverse cardiovascular events.