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2w ago

EU Confirms Suicide Risk Linked to Hair Loss Drug Finasteride

European regulators conclude that finasteride and dutasteride pose a potential risk of suicidal ideation but affirm their benefits outweigh the risks for approved uses.

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El tipo de alopecia más habitual es la androgénica.
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Overview

  • The European Medicines Agency (EMA) has completed an eight-month safety review, identifying 325 cases of suicidal ideation linked to 5-alpha-reductase inhibitors, primarily finasteride 1 mg for hair loss treatment.
  • The Pharmacovigilance Risk Assessment Committee (PRAC) confirmed that the therapeutic benefits of finasteride and dutasteride still outweigh their risks for all approved uses.
  • New regulatory measures include updated product labeling, mood and sexual function warnings, and patient information cards for finasteride 1 mg users.
  • No evidence was found linking suicidal ideation to topical finasteride, and no product information changes will be made for that formulation.
  • The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) will finalize the updated labeling changes across EU member states.