The European Medicines Agency confirms that finasteride poses a risk for suicidal ideation and urges healthcare professionals to be alert for mood changes in treated patients.
by the EMA’s Pharmacovigilance Risk Assessment Committee . The review of the benefit-risk balance was undertaken following notification by France of a referral under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data.
However, the committee concluded that the benefits of both finasteride and dutasteride continued to outweigh their risks for all approved uses.
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