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Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: new measures to minimise the risk of suicidal thoughts

Active substance: finasteride, dutasteride

The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), wish to inform that suicidal thoughts is an adverse drug reaction of orally administered finasteride-containing products and is mainly reported in patients treated for androgenetic alopecia. Patients treated with oral finasteride for androgenetic alopecia should be advised to discontinue treatment and seek medical advice if they experience depressed mood, depression or suicidal thoughts.

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