Search Results for 'REMS'

[gregoryglass]

Product: Propecia®(finasteride) and Proscar®(finasteride) Tablets
Company: Merck
Petition Filer: Post-finasteride Syndrome Foundation
Petition Number(s): 2017P-5787
Date of Petition: September 19, 2017
Responding Petitions:

Issue and Implication: Whether FDA standards for evaluating risk of a product versus its benefits are sufficient to ensure safe product use.

Action Requested by Petitioner: The Petitioner requests many things, essentially asking for the removal of the 1mg Propecia®(finasteride) product but at the very least have FDA implement several Risk Evaluation and Mitigation Strategy (REMS) components – boxed warnings, Dear Doctor letters, etc for these products.

Summary of Petition(s): Petitioner is an advocacy group for those patients who have had adverse reactions to these products. Specifically, Petitioner claims that studies and product experience demonstrate that these products cause sexual dysfunction and psychoneurocognitive symptoms that develop while taking the product and even after with no reversal of the issues once off the medication. The products have marginal benefit but can cause years and decades of issues for men who have taken these products. The FDA needs to re-evaluate them based on the terrible risks demonstrated versus few benefits and either remove these products or restrict their use through warnings, distribution, etc.

FDA Action: Pending.

Citizen Petition

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