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# Public Citizen Wants Prolia Boxed Warning
- URL: https://www.fdaweb.com/public-citizen-wants-prolia-boxed-warning/
- Published: 2019-04-16T12:00:00.000Z
- Updated: 2026-09-15T01:20:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143872

Public Citizen is petitioning FDA to add a Boxed Warning to labeling for Amgen’s osteoporosis drug Prolia (denosumab) to describe the risk of vertebral fractures upon discontinuing the drug. The advocacy group’s 4/16 [petition](https://www.citizen.org/sites/default/files/2478.pdf?eType=EmailBlastContent&eId=67e1fcd9-5c85-412b-adeb-e3abed1c4b1d&ref=fdaweb.com) says “there is a growing body of evidence that cessation of Prolia is associated with an increased risk of multiple vertebral fractures. The risk of this serious adverse event could be mitigated with a prominent Boxed Warning and an updated risk evaluation and mitigation strategy (REMS) that together would increase physician and patient awareness about the risks associated with treatment cessation.”

The petition includes Public Citizen’s suggested wording for a Boxed Warning and elements that it says should be added to the REMS.

In a separate media [statement](https://www.citizen.org/media/press-releases/patients-doctors-must-be-warned-about-risk-spinal-fractures-soon-after-stopping?ref=fdaweb.com), Public Citizen says that unlike other osteoporosis treatments, Prolia’s positive effects on bone are short-lived and readily reversible if the drug is discontinued. It says that one study cited in the petition described 24 patients who collectively experienced 112 new spinal fractures.

The petition says the current labeling has the risk included in a Warning “buried deep in the label” and asks that it be replaced with a more prominent Boxed Warning at the top of the labeling. It also asks FDA to require Amgen to send letters to doctors and develop updated patient brochures that warn of the increased risk of spinal fractures if the medication is stopped or a scheduled six-month dose is missed.