What changed: official texts by date
Documents from medicines regulators about SSRIs, SNRIs, finasteride, dutasteride and isotretinoin, newest first, each linked to the official source.
This page lists, by date, the documents that medicines regulators have published about the medicines on our label table, and the letters companies have sent to health professionals on a regulator’s site. Newest first.
The list is made from the documents on record in that table. It does not say what a document says: its words are in the table rows it links to, next to the official source.
Two kinds of document are not in this list. Answers given by governments in parliament are not label changes, and documents that print no date cannot be placed in time. Both are in the table.
The list grows when we have verified a new text.
2026
· United Kingdom
Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction
Document from the regulator · Issued by: MHRA
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine
Checked · Original document
· United Kingdom
Antidepressants: use and safety
Document from the regulator · Issued by: MHRA
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine
Checked · Original document
· United Kingdom
Direct Healthcare Professional Communication (DHPC): "Finasteride and dutasteride - Updated safety warnings for psychiatric side effects and sexual dysfunction"
Company letter to health professionals, on the regulator's site (MHRA)
On record for: Finasteride, Dutasteride
Checked · Original document
· United States
SUPPLEMENT APPROVAL, NDA 021951/S-031 and NDA 211913/S-023
Document from the regulator · Issued by: FDA
On record for: Isotretinoin
Checked · Original document
· United States
Drug Safety-related Labeling Changes (SrLC): ABSORICA (NDA-021951) (ISOTRETINOIN)
Document from the regulator · Issued by: FDA
On record for: Isotretinoin
Checked · Original document
· United States
FDA Requests Labeling Updates for Generic Isotretinoin Products
Document from the regulator · Issued by: FDA
On record for: Isotretinoin
Checked · Original document
· New Zealand
Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026
Document from the regulator · Issued by: Medsafe
On record for: Sertraline, Citalopram, Escitalopram, Paroxetine, Venlafaxine
Checked · Original document
· Canada
Health Product InfoWatch, June 2026
Document from the regulator · Issued by: Health Canada
On record for: Finasteride, Dutasteride
Checked · Original document
· United Kingdom
Drug Safety Update: "Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction"
Document from the regulator · Issued by: MHRA
On record for: Finasteride
Checked · Original document
· United Kingdom
Press release: "MHRA strengthens safety warnings for finasteride and dutasteride"
Document from the regulator · Issued by: MHRA
On record for: Finasteride, Dutasteride
Checked · Original document
· New Zealand
Recent data sheet updates: Important new safety information
Document from the regulator · Issued by: Medsafe
On record for: Isotretinoin
Checked · Original document
· France
Finastéride 1 mg : une attestation d’information partagée bientôt nécessaire pour toute dispensation
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· France
Dossier thématique « Finastéride 1 mg et chute de cheveux », page « Risques liés à la prise de finastéride 1 mg »
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· Saudi Arabia
Direct Healthcare Professional Communication: Isotretinoin (Roaccutane®) – Important Safety Information on Psychiatric and Sexual Disorders
Company letter to health professionals, on the regulator's site (SFDA)
On record for: Isotretinoin
Checked · Original document
· France
Attestation d’information partagée : attestation destinée aux patients traités par les spécialités à base de finastéride 1 mg
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
2025
· United Kingdom
MHRA Safety Roundup: December 2025
Document from the regulator · Issued by: MHRA
On record for: Sertraline
Checked · Original document
· United Kingdom
Patient and family experiences inform antidepressant safety information review
Document from the regulator · Issued by: MHRA
On record for: Sertraline
Checked · Original document
· European Union
Isotretinoin (oral formulations) : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) - PSUSA/00010488/202505
Document from the regulator · Issued by: EMA
On record for: Isotretinoin
Checked · Original document
· France
Finastéride et risque d’idées suicidaires : nouvelles mesures
Document from the regulator · Issued by: ANSM
On record for: Finasteride, Dutasteride
Checked · Original document
· Germany
Finasterid- und dutasteridhaltige Arzneimittel: Suizidale Gedanken und Verhaltensweisen
Document from the regulator · Issued by: BfArM
On record for: Dutasteride
Checked · Original document
· Italy
Nota Informativa Importante di Sicurezza concordata con le Autorita’ Regolatorie Europee e l’Agenzia Italiana del Farmaco (AIFA)
Company letter to health professionals, on the regulator's site (AIFA)
On record for: Finasteride
Checked · Original document
· Germany
Rote-Hand-Brief zu Finasterid und Dutasterid: Neue Maßnahmen zur Minimierung des Risikos für Suizidgedanken
Company letter to health professionals, on the regulator's site (BfArM)
On record for: Finasteride, Dutasteride
Checked · Original document
· France
Médicaments à base de Finastéride ou de Dutastéride – Nouvelles mesures pour réduire le risque d'idées suicidaires
Company letter to health professionals, on the regulator's site (ANSM)
On record for: Dutasteride
Checked · Original document
· European Union
Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines
Document from the regulator · Issued by: EMA
On record for: Finasteride, Dutasteride
Checked · Original document
· France
Risques liés à la prise d’isotrétinoïne par voie orale
Document from the regulator · Issued by: ANSM
On record for: Isotretinoin
Checked · Original document
· France
Retour d’information sur le PRAC de mai 2025 (5 – 8 mai)
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· Spain
Nota de seguridad MUH (FV), 02/2025: «La AEMPS informa de las nuevas recomendaciones para minimizar el riesgo de ideación suicida en pacientes tratados con finasterida»
Document from the regulator · Issued by: AEMPS
On record for: Finasteride
Checked · Original document
· Malaysia
Arahan Pengarah Perkhidmatan Farmasi Bilangan 7 Tahun 2025: Direktif untuk semua produk yang mengandungi isotretinoin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko sacroiliitis dan urethritis
Document from the regulator · Issued by: NPRA
On record for: Isotretinoin
Checked · Original document
· European Union
Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines
Document from the regulator · Issued by: EMA
On record for: Dutasteride
Checked · Original document
· Italy
Misure per minimizzare il rischio di pensieri suicidari con i medicinali contenenti finasteride e dutasteride
Document from the regulator · Issued by: AIFA
On record for: Finasteride
Checked · Original document
· United States
FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products
Document from the regulator · Issued by: FDA
On record for: Finasteride
Checked · Original document
· Saudi Arabia
Direct Healthcare Professional Communication (DHPC)
Company letter to health professionals, on the regulator's site (SFDA)
On record for: Isotretinoin
Checked · Original document
2024
· France
Retour d’information sur le PRAC d’octobre 2024 (30 septembre – 3 octobre)
Document from the regulator · Issued by: ANSM
On record for: Dutasteride
Checked · Original document
· France
Réévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastéride
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· Canada
Health Product InfoWatch, July 2024
Document from the regulator · Issued by: Health Canada
On record for: Isotretinoin
Checked · Original document
· United Kingdom
Drug Safety Update: "Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)"
Document from the regulator · Issued by: MHRA
On record for: Finasteride
Checked · Original document
· United Kingdom
Press release: "Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects"
Document from the regulator · Issued by: MHRA
On record for: Finasteride
Checked · Original document
· United Kingdom
Safety review of Finasteride. Public Assessment Report
Document from the regulator · Issued by: MHRA
On record for: Finasteride
Checked · Original document
2023
· United Kingdom
Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age
Document from the regulator · Issued by: MHRA
On record for: Isotretinoin
Checked · Original document
· Malaysia
Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction
Document from the regulator · Issued by: NPRA
On record for: Isotretinoin
Checked · Original document
· New Zealand
Minutes of the 195th Medicines Adverse Reactions Committee Meeting, 14 September 2023
Document from the regulator · Issued by: Medsafe
On record for: Isotretinoin
Checked · Original document
· France
Finastéride 1 mg (Propecia et génériques) : ajout de mentions d’alerte sur les boîtes pour renforcer l’information sur les effets indésirables
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· United Kingdom
REPORT OF THE COMMISSION ON HUMAN MEDICINES ISOTRETINOIN EXPERT WORKING GROUP
Document from the regulator · Issued by: MHRA
On record for: Isotretinoin
Checked · Original document
· United Kingdom
Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years
Document from the regulator · Issued by: MHRA
On record for: Isotretinoin
Checked · Original document
2022
· Italy
Comunicazione di sicurezza: FINASTERIDE 1 mg e possibili disturbi sessuali e psichiatrici
Document from the regulator · Issued by: AIFA
On record for: Finasteride
Checked · Original document
· France
FINASTERIDE 1 mg (Propecia® et génériques) Pour la chute des cheveux : information pour les patients
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· United States
SUPPLEMENT APPROVAL: NDA 020788/S-030
Document from the regulator · Issued by: FDA
On record for: Finasteride
Checked · Original document
2021
· Canada
Health Product InfoWatch, December 2021
Document from the regulator · Issued by: Health Canada
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine
Checked · Original document
· United States
Drug Safety-related Labeling Changes (SrLC): ZOLOFT (NDA-019839) (SERTRALINE HYDROCHLORIDE)
Document from the regulator · Issued by: FDA
On record for: Sertraline
Checked · Original document
· New Zealand
Gathering knowledge from adverse reaction reports: March 2021
Document from the regulator · Issued by: Medsafe
On record for: Sertraline
Checked · Original document
· Canada
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation
Document from the regulator · Issued by: Health Canada
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine
Checked · Original document
2019
· New Zealand
Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019
Document from the regulator · Issued by: Medsafe
On record for: Sertraline, Citalopram, Escitalopram, Paroxetine
Checked · Original document
· Spain
Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019
Document from the regulator · Issued by: AEMPS
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine
Checked · Original document
· European Union
New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC
Document from the regulator · Issued by: EMA
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine, Milnacipran
Checked · Original document
· European Union
PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting
Document from the regulator · Issued by: EMA
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine, Milnacipran
Checked · Original document
· France
Xeljanz® (tofacitinib), Fenspiride (Pneumorel), ibuprofène et kétoprofène : retour d’information sur le PRAC de mai 2019
Document from the regulator · Issued by: ANSM
On record for: Sertraline
Checked · Original document
· Germany
Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019
Document from the regulator · Issued by: BfArM
On record for: Sertraline, Citalopram, Escitalopram, Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Duloxetine, Desvenlafaxine, Milnacipran
Checked · Original document
· Malaysia
Arahan Pengarah Kanan Perkhidmatan Farmasi Bilangan 6 Tahun 2019: Direktif untuk semua produk yang mengandungi retinoid (oral): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan neuropsychiatric disorders
Document from the regulator · Issued by: NPRA
On record for: Isotretinoin
Checked · Original document
· Germany
Bescheid vom 19.02.2019: Umsetzung der zwei einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh/439088/2017 vom 19.07.2017 und EMA/CMDh/848760/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff „Isotretinoin (orale Darreichungsformen)“
Document from the regulator · Issued by: BfArM
On record for: Isotretinoin
Checked · Original document
· France
Finastéride : rappel sur les risques de troubles psychiatriques et de la fonction sexuelle
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· France
Lettre aux professionnels de santé, Février 2019 : Finastéride (Propecia, Chibro-Proscar, génériques) : rappel sur les risques de troubles de la fonction sexuelle et de troubles psychiatriques
Company letter to health professionals, on the regulator's site (ANSM)
On record for: Finasteride
Checked · Original document
2018
· India
Safety guidelines for Isotretinoin - Regarding
Document from the regulator · Issued by: CDSCO
On record for: Isotretinoin
Checked · Original document
· Germany
Bulletin zur Arzneimittelsicherheit, Ausgabe 3, September 2018: „Depressionen und sexuelle Funktionsstörungen unter Anwendung von Finasterid zur Behandlung der androgenetischen Alopezie“
Document from the regulator · Issued by: BfArM
On record for: Finasteride
Checked · Original document
· Italy
Nota Informativa Importante concordata con l’Agenzia Italiana del Farmaco (AIFA)
Company letter to health professionals, on the regulator's site (AIFA)
On record for: Finasteride
Checked · Original document
· Germany
Rote-Hand-Brief zu Finasterid: Risiko sexueller Dysfunktionen und psychischer Störungen
Company letter to health professionals, on the regulator's site (BfArM)
On record for: Finasteride
Checked · Original document
· European Union
Updated measures for pregnancy prevention during retinoid use. Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids
Document from the regulator · Issued by: EMA
On record for: Isotretinoin
Checked · Original document
2017
· France
Point d’Information du 26 octobre 2017 : Finastéride : surveiller le risque de dépression et d’idées suicidaires
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
· United Kingdom
Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido
Document from the regulator · Issued by: MHRA
On record for: Isotretinoin
Checked · Original document
· Spain
Boletín mensual de la AEMPS sobre medicamentos de uso humano. Septiembre de 2017
Document from the regulator · Issued by: AEMPS
On record for: Isotretinoin
Checked · Original document
· European Union
Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611
Document from the regulator · Issued by: EMA
On record for: Isotretinoin
Checked · Original document
· United Kingdom
Drug Safety Update: "Finasteride: rare reports of depression and suicidal thoughts"
Document from the regulator · Issued by: MHRA
On record for: Finasteride
Checked · Original document
· Canada
Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)
Document from the regulator · Issued by: Health Canada
On record for: Isotretinoin
Checked · Original document
2016
· New Zealand
Post-Finasteride Syndrome
Document from the regulator · Issued by: Medsafe
On record for: Finasteride
Checked · Original document
2013
· United States
SUPPLEMENT APPROVAL: NDA 020180/S-043
Document from the regulator · Issued by: FDA
On record for: Finasteride
Checked · Original document
2012
· United States
SUPPLEMENT APPROVAL: NDA 020788/S-020, S-021, S-023
Document from the regulator · Issued by: FDA
On record for: Finasteride
Checked · Original document
· United States
SUPPLEMENT APPROVAL: NDA 020180/S-040, S-041, S-042
Document from the regulator · Issued by: FDA
On record for: Finasteride
Checked · Original document
· France
Point d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondaires
Document from the regulator · Issued by: ANSM
On record for: Finasteride
Checked · Original document
2011
· United States
SUPPLEMENT APPROVAL: NDA 18-936/S-096, NDA 21-235/S-018
Document from the regulator · Issued by: FDA
On record for: Fluoxetine
Checked · Original document