Safety Public Assessment Reports
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How Safety Public Assessment Reports work
The Safety Public Assessment Reports (PARs) cover medicines safety issues assessed at a national level by the Commission on Human Medicines (CHM) or its advisory groups. We prioritise the publication of PARs that relate to major national regulatory action.
The reports show the evidence that was available at the time we made the regulatory decision, showing a 鈥榮napshot鈥� of the clinical landscape at the time. They are not intended to provide clinical advice.
Since 2012, most safety issues are assessed at an EU level. Reports for these issues can be found on the (EMA) or websites.
We publish updates and prescribing updates on a wide range of medicines in our monthly Drug Safety Update
We also publish .
2025
Modified Release Opioids and Treatment of Post-operative Pain
Valproate: Managing reproductive risks in male patients under 55
2024
Topiramate: review of safety in pregnancy
Finasteride: review of safety data and expert advice on management of risks
2023
Valproate: review of safety data and expert advice on management of risks
2022
2021
Antiepileptic drugs: review of safety of use during pregnancy
Topical steroid withdrawal reactions: a review of the evidence
Review of the use of haloperidol in elderly patients with acute delirium
2020
Public Assessment Report of over-the-counter stimulant laxatives: benefit-risk review
2019
(21 November 2019)
2018
(13 December 2018)
2017
(20 June 2017)
2015
(9 September 2015)
(27 January 2015)
2014
2013
(20 March 2013)
2012
(5 December 2012)
(29 October 2012)
(29 October 2012)
(25 May 2012)
2011
(14 November 2011)
(14 September 2011)
(10 September 2011)
(1 September 2011)
(30 August 2011)
(1 May 2011)
(1 April 2011)
(1 February 2011)
2010
(23 December 2010)
(11 October 2010)
(1 October 2010)
(15 September 2010)
(30 July 2010)
(1 February 2010)
(1 January 2010)
2009
(3 December 2009)
(3 December 2009)
(3 November 2009)
(1 November 2009)
(1 November 2009)
(1 September 2009)
(1 July 2009)
(1 June 2009)
2008
(1 February 2008)
Recombinant human erythropoietins (epoetins): new prescribing advice (01 December 2007)
(3 September 2007)
(1 May 2007)
(1 February 2007)
(1 November 2006)
(1 July 2006)
(1 July 2006)
Updates to this page
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Added PAR for 'Modified Release Opioids and Treatment of Post-operative Pain'
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Added Public Assessment Report for 'Valproate: Managing reproductive risks in male patients under 55'.
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Added new guidance for Valproate: Paternal exposure to valproate and risk of neurodevelopmental disorders and congenital malformations in offspring
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Added 'Topiramate: review of safety in pregnancy' to 2024 Public Assessment Reports.
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Added 'Finasteride: review of safety data and expert advice on management of risks' to 2024 reports
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Added 'Finasteride: review of safety data and expert advice on management of risks' to 2024 reports.
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Added public assessment report 'Valproate: review of safety data and expert advice on management of risks'
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Addition of PAR for Hydroxychloroquine or chloroquine, in combination with macrolide antibiotics: review of epidemiological data for cardiovascular safety
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Addition of PAR for Chloramphenicol eye drops containing borax and boric acid buffers: review of the use in children under 2 years
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Addition of the Public Assessment Report on our review of the risks of using haloperidol for the acute treatment of delirium in elderly patients.
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Added a link to the new Public Assessment Report: safety of macrolide antibiotics in pregnancy: a review of the epidemiological evidence
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Added links to the Antiepileptic drugs: review of safety of use during pregnancy and the Public Assessment Report of over-the-counter stimulant laxatives: benefit-risk review
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First published.