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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 snapshot 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 European Medicines Agency (EMA) or Head of Medicines Agency websites.

We publish updates and prescribing updates on a wide range of medicines in our monthly Drug Safety Update

We also publish standard Public Assessment Reports.

2024

Topiramate: review of safety in pregnancy

Finasteride: review of safety data and expert advice on management of risks

MHRA Public consultation on the proposal to make Codeine Linctus available as a prescription-only medicine (POM)

2023

Valproate: review of safety data and expert advice on management of risks

2022

Chloramphenicol eye drops containing borax and boric acid buffers: review of the use in children under 2 years

Hydroxychloroquine or chloroquine, in combination with macrolide antibiotics: review of epidemiological data for cardiovascular safety

2021

Public Assessment Report: safety of macrolide antibiotics in pregnancy: a review of the epidemiological evidence

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

Yellow fever vaccine - benefit-risk and risk minimisation measures (21 November 2019)

2018

Oral lidocaine products: risk minimisation measures for use in teething (13 December 2018)

2017

Pseudoephedrine and ephedrine managing the risk of medicines misuse (PDF, 62.5 KB, 12 pages) (20 June 2017)

2015

Pseudoephedrine and ephedrine managing the risk of medicines misuse 2015 (PDF, 99.5 KB, 12 pages) (9 September 2015)

Reclassification of Nexium Control 20mg Gastro-Resistant Tablets (PDF, 104 KB, 8 pages) (27 January 2015)

2014

Review of isotretinoin and psychiatric adverse reactions (2014) (PDF, 501 KB, 38 pages)

2013

Aqueous cream contains sodium lauryl sulfate which may cause skin reactions, particularly in children with eczema (PDF, 181 KB, 21 pages) (20 March 2013)

2012

Cervarix HPV vaccine safety update at end of 4 years routine use in HPV immunisation programme (PDF, 342 KB, 27 pages) (5 December 2012)

Pseudoephedrine and ephedrine managing the risk of misuse - 2012 review (PDF, 111 KB, 11 pages) (29 October 2012)

0.18% saline or 4% glucose IV solution safety risks in children (PDF, 144 KB, 24 pages) (29

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