Guidance

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 ‘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.

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, 62.5KB, 12 pages) (20 June 2017)

2015

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

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

2013

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

2012

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

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

0.18% saline or 4% glucose IV solution safety risks in children (PDF, 144KB, 24 pages) (29 October 2012)

Atomoxetine effects on heart rate and blood pressure (PDF, 194KB, 23 pages) (25 May 2012)

2011

Liquid paracetamol for children revised UK dosing instructions introduced (PDF, 381KB, 36 pages) (14 November 2011)

Reboxetine review of benefits and risks (PDF, 116KB, 16 pages) (14 September 2011)

Fluoxetine in pregnancy slight risk of heart defects in unborn child (PDF, 108KB, 12 pages) (10 September 2011)

Tamoxifen reduced effectiveness when used with CYP2D6 inhibitors (PDF, 124KB, 19 pages) (1 September 2011)

Pseudoephedrine and ephedrine managing the risk of misuse 2011 review (PDF, 109KB, 11 pages) (30 August 2011)

Combined oral contraceptives (the pill) when to start taking the pill, and missed pill advice (PDF, 121KB, 18 pages) (1 May 2011)

Nicobrevin withdrawn from UK market as risks outweigh benefits (PDF, 179KB, 24 pages) (1 April 2011)

Swine flu vaccines and antiviral medicines UK post-pandemic safety review (PDF, 249KB, 41 pages) (1 February 2011)

2010

Seasonal flu vaccines no evidence of an increased risk of febrile convulsions in children (PDF, 74.5KB, 11 pages) (23 December 2010)

Oral liquid cough medicines containing codeine should not be used in those aged less than 18 years (PDF, 200KB, 22 pages) (11 October 2010)

Cervarix (HPV) vaccine update on UK safety in the first 2 years of the HPV immunisation programme (PDF, 246KB, 31 pages) (1 October 2010)

Calcium gluconate 10% in 10 mL glass containers risk of aluminium exposure (PDF, 124KB, 13 pages) (15 September 2010)

Pseudoephedrine and ephedrine managing the risk of misuse – July 2010 update (PDF, 248KB, 11 pages) (30 July 2010)

Nicotine replacement therapy harm reduction in smokers (PDF, 64KB, 9 pages) (1 February 2010)

Non-steroidal anti-inflammatory drugs (NSAIDs) cardiovascular risks (PDF, 382KB, 33 pages) (1 January 2010)

2009

Warfarin changes to safety information (PDF, 157KB, 19 pages) (3 December 2009)

Finasteride risk of male breast cancer (PDF, 288KB, 27 pages) (3 December 2009)

Statins update to product safety information (PDF, 313KB, 32 pages) (3 November 2009)

Vigabatrin brain MRI abnormalities and movement disorders (PDF, 134KB, 15 pages) (1 November 2009)

Orciprenaline sulphate (Alupent) withdrawal from UK market after a risk-benefit analysis (PDF, 259KB, 13 pages) (1 November 2009)

Codeine and dihydrocodeine minimising the risk of addiction (PDF, 58.5KB, 16 pages) (1 September 2009)

Pseudoephedrine and ephedrine managing the risk of misuse - 2009 update (PDF, 141KB, 18 pages) (1 July 2009)

Risk of venous thromboembolism associated with antipsychotics (PDF, 608KB, 37 pages) (1 June 2009)

2008

Efficacy of progestogens in the maintenance of early pregnancy in women with threatened miscarriage or recurrent miscarriage (PDF, 151KB, 20 pages) (1 February 2008)

Recombinant human erythropoietins (epoetins): new prescribing advice (01 December 2007)

Hormone replacement therapy (HRT) safety update (PDF, 668KB, 45 pages) (3 September 2007)

α-1 adrenoceptor antagonists and intraoperative floppy iris syndrome (IFIS) (PDF, 151KB, 17 pages) (1 May 2007)

Gadolinium-containing MRI contrast agents nephrogenic systemic fibrosis (PDF, 239KB, 24 pages) (1 February 2007)

Dopamine agonists pathological gambling and increased libido (PDF, 340KB, 20 pages) (1 November 2006)

Neuroleptics and cardiac safety (PDF, 59.2KB, 5 pages) (1 July 2006)

Black cohosh and liver injury (PDF, 100KB, 8 pages) (1 July 2006)

Published 4 January 2019