Search Results for 'REMS'

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Product: Prolia®(denosumab) Injection
Company: Amgen
Petition Filer: Public Citizen
Petition Number(s): 2019P-1818
Date of Petition: April 17, 2019
Responding Petitions: Amgen

Issue and Implication: Whether additional evidence regarding the safety profile of a drug merits changes to the label.

Action Requested by Petitioner: The Petitioner is asking FDA to require Amgen to add a boxed warning and send out “Dear Doctor” REMS letter warning of the risks of vertebral fracture upon cessation of the drug therapy.

Summary of Petition(s): Petitioner claims that there is mounting and growing data and evidence demonstrating that there is an increased risk and likelihood that patients will have vertebral fractures once they are taken off this medication. As such, Petitioner argues FDA must add a boxed warning and require Amgen to notify prescribers regarding the risk. Specifically, Petitioner simply wants to warn prescribers and patients that bone fractures may occur as early as 7 months after cessation (and on average about 19 months) and to suggest a mitigating course of therapy after cessation such as a bisphosphonate.

On August 2, 2019, Amgen issued a response, asking FDA to deny the petition. Amgen notes that it has alerted FDA to risks that have been associated with this product. Working with FDA, FDA has already reviewed all of the data regarding the risks and has already added these changes and modifications to the label and medication guide. Essentially, FDA has already reviewed this issue, and the Petition adds no new information. As such, FDA should consider this issued considered and closed.

FDA Action: On April 23, 2020, FDA denied this petition.

Citizen Petition
Amgen Response
FDA Action

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