FDA Accepts Few Labeling Changes for Propecia

FDA has denied most of a 9/18/17 petition submitted by the Post-Finasteride Syndrome Foundation seeking immediate removal from the market of Propecia and all its generic forms or significant labeling changes. However, the agency did agree to order a few labeling changes.

The 43-page denial letter says FDA is requiring Organon to make labeling changes to clarify the risks of using Propecia. The agency is requiring the addition of suicidal ideation and behavior to the list of nervous system/psychiatric reactions in the Adverse Reaction section and ordering additional changes.

“With those changes,” the letter says, “the Propecia labeling adequately describes the risk of sexual dysfunction and psychoneurocognitive adverse events with the use of Propecia and upon drug discontinuation.”

FDA denied the petition’s requests for additional information to be added to the Warnings and Precautions, Contraindications, Adverse Reactions, Clinical Pharmacology, and Boxed Warning sections of the labeling for Propecia and Proscar (finasteride). It also denied the request to require Organon to implement a Risk Evaluation and Mitigation Strategy and denied the request to remove Propecia from the market.

“The totality of the evidence presented in your petition does not provide reasonable evidence to support a causal association between Propecia use and persistent and permanent sexual dysfunction, male infertility, or impaired spermatogenesis, depression, suicidal ideation/behavior, anxiety, cognitive dysfunction, and fatigue,” the letter says. The majority of your labeling change requests … are not warranted. The literature you submitted fails to support your proposed labeling changes due to study design flaws and limitations….”