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Petition to the FDA to Require a Black-Box Warning for the Osteoporosis Drug Prolia

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Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the osteoporosis drug, Prolia (denosumab), to alert doctors and patients about the risk of vertebral fractures associated with cessation of the drug and need for alternative osteoporosis treatment after stopping the drug.

April 16, 2019, FDA acknowledgment letter.

October 11, 2019, FDA interim response letter.

April 23, 2020, FDA final response letter.