Guidance: Safety Public Assessment Reports

Medicines Healthcare Products Regulatory Agency

June 20
10:11 2024

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.


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)


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


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


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


Public Assessment Report of over-the-counter stimulant laxatives: benefit-risk review


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


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


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


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)


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


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


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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