# Safety Public Assessment Reports Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/161ac136-9a24-48cf-b2bf-c37b524be76d Type: Detailed Guide Published: January 4, 2019 Updated: January 26, 2026 > This document outlines the Medicines and Healthcare products Regulatory Agency (MHRA) framework for Safety Public Assessment Reports (PARs), which summarize national-level safety assessments conducted by the Commission on Human Medicines (CHM). Rather than focusing on a single company, the document provides a comprehensive overview of safety reviews and regulatory actions across the pharmaceutical industry between 2006 and 2026. Major safety issues identified in these reports include neurodevelopmental risks associated with Valproate, addiction potential in opioid-based medications like Codeine, and severe side effects linked to fluoroquinolone antibiotics. The regulatory framework emphasizes that while pre-2012 assessments were primarily national, post-2012 issues are often handled at the EU level via the European Medicines Agency (EMA). Required actions following these assessments typically involve significant updates to prescribing information, the implementation of risk minimization strategies, and the reclassification of medicines—such as transitioning Codeine Linctus to prescription-only status. These reports function as evidence-based snapshots of regulatory decisions at specific points in time to improve public transparency and drug safety management. --- ## Content 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 . 2026 Improving information supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs Review of the impact of recommendations for the prescribing of isotretinoin 2025 Review of risk minimisation for disabling and potentially long-lasting/irreversible side effects associated with fluoroquinolone antibiotics Modified Release Opioids and Treatment of Post-operative Pain Valproate: Managing reproductive risks in male patients under 55 2024 Valproate: Paternal exposure to valproate and risk of neurodevelopmental disorders and congenital malformations in offspring 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 October 2012) Atomoxetine effects on heart rate and blood pressure ( PDF , 194 KB , 23 pages ) (25 May 2012) 2011 Liquid paracetamol for children revised UK dosing instructions introduced ( PDF , 381 KB , 36 pages ) (14 November 2011) Reboxetine review of benefits and risks ( PDF , 116 KB , 16 pages ) (14 September 2011) Fluoxetine in pregnancy slight risk of heart defects in unborn child ( PDF , 108 KB , 12 pages ) (10 September 2011) Tamoxifen reduced effectiveness when used with CYP2D6 inhibitors ( PDF , 124 KB , 19 pages ) (1 September 2011) Pseudoephedrine and ephedrine managing the risk of misuse 2011 review ( PDF , 109 KB , 11 pages ) (30 August 2011) Combined oral contraceptives (the pill) when to start taking the pill, and missed pill advice ( PDF , 121 KB , 18 pages ) (1 May 2011) Nicobrevin withdrawn from UK market as risks outweigh benefits ( PDF , 179 KB , 24 pages ) (1 April 2011) Swine flu vaccines and antiviral medicines UK post-pandemic safety review ( PDF , 249 KB , 41 pages ) (1 February 2011) 2010 Seasonal flu vaccines no evidence of an increased risk of febrile convulsions in children ( PDF , 74.5 KB , 11 pages ) (23 December 2010) Oral liquid cough medicines containing codeine should not be used in those aged less than 18 years ( PDF , 200 KB , 22 pages ) (11 October 2010) Cervarix (HPV) vaccine update on UK safety in the first 2 years of the HPV immunisation programme ( PDF , 246 KB , 31 pages ) (1 October 2010) Calcium gluconate 10% in 10 mL glass containers risk of aluminium exposure ( PDF , 124 KB , 13 pages ) (15 September 2010) Pseudoephedrine and ephedrine managing the risk of misuse – July 2010 update ( PDF , 248 KB , 11 pages ) (30 July 2010) Nicotine replacement therapy harm reduction in smokers ( PDF , 64 KB , 9 pages ) (1 February 2010) Non-steroidal anti-inflammatory drugs (NSAIDs) cardiovascular risks ( PDF , 382 KB , 33 pages ) (1 January 2010) 2009 Warfarin changes to safety information ( PDF , 157 KB , 19 pages ) (3 December 2009) Finasteride risk of male breast cancer ( PDF , 288 KB , 27 pages ) (3 December 2009) Statins update to product safety information ( PDF , 313 KB , 32 pages ) (3 November 2009) Vigabatrin brain MRI abnormalities and movement disorders ( PDF , 134 KB , 15 pages ) (1 November 2009) Orciprenaline sulphate (Alupent) withdrawal from UK market after a risk-benefit analysis ( PDF , 259 KB , 13 pages ) (1 November 2009) Codeine and dihydrocodeine minimising the risk of addiction ( PDF , 58.5 KB , 16 pages ) (1 September 2009) Pseudoephedrine and ephedrine managing the risk of misuse - 2009 update ( PDF , 141 KB , 18 pages ) (1 July 2009) Risk of venous thromboembolism associated with antipsychotics ( PDF , 608 KB , 37 pages ) (1 June 2009) 2008 Efficacy of progestogens in the maintenance of early pregnancy in women with threatened miscarriage or recurrent miscarriage ( PDF , 151 KB , 20 pages ) (1 February 2008) Recombinant human erythropoietins (epoetins): new prescribing advice (01 December 2007) Epoetins for the management of anaemia associated with cancer risk of tumour progression and mortality ( PDF , 661 KB , 36 pages ) Epoetins for the management of anaemia in patients with chronic renal disease mortality and cardiovascular morbidity ( PDF , 324 KB , 26 pages ) Hormone replacement therapy (HRT) safety update ( PDF , 668 KB , 45 pages ) (3 September 2007) α-1 adrenoceptor antagonists and intraoperative floppy iris syndrome (IFIS) ( PDF , 151 KB , 17 pages ) (1 May 2007) Gadolinium-containing MRI contrast agents nephrogenic systemic fibrosis ( PDF , 239 KB , 24 pages ) (1 February 2007) Dopamine agonists pathological gambling and increased libido ( PDF , 340 KB , 20 pages ) (1 November 2006) Neuroleptics and cardiac safety ( PDF , 59.2 KB , 5 pages ) (1 July 2006) Black cohosh and liver injury ( PDF , 100 KB , 8 pages ) (1 July 2006) ## Attachments - [0.18% saline or 4% glucose IV solution safety risks in children](https://assets.publishing.service.gov.uk/media/5df7610bed915d093931ae90/0.18__saline_or_4__glucose_IV_solution_safety_risks_in_children.pdf) - [Aqueous cream contains sodium lauryl sulfate which may cause skin reactions, particularly in children with eczema](https://assets.publishing.service.gov.uk/media/5df7610ce5274a090e4827f5/Aqueous_cream_contains_sodium_lauryl_sulfate_which_may_cause_skin_reactions__particularly_in_children_with_eczema.pdf) - [Atomoxetine effects on heart rate and blood pressure](https://assets.publishing.service.gov.uk/media/5df7610c40f0b609574bca10/Atomoxetine_effects_on_heart_rate_and_blood_pressure.pdf) - [Black cohosh and liver injury](https://assets.publishing.service.gov.uk/media/5df7610ce5274a08f78bca34/Black_cohosh_and_liver_injury.pdf) - [Calcium gluconate 10% in 10 mL glass containers risk of aluminium exposure](https://assets.publishing.service.gov.uk/media/5df7610bed915d093931ae91/Calcium_gluconate_10__in_10_mL_glass_containers_risk_of_aluminium_exposure.pdf) - [Cervarix (HPV) vaccine update on UK safety in the first 2 years of the HPV immunisation programme](https://assets.publishing.service.gov.uk/media/5df7610ce5274a08de86824c/Cervarix__HPV__vaccine_update_on_UK_safety_in_the_first_2_years_of_the_HPV_immunisation_programme.pdf) - [Cervarix HPV vaccine safety update at end of 4 years routine use in HPV immunisation programme](https://assets.publishing.service.gov.uk/media/5df7610c40f0b609497ff0e8/Cervarix_HPV_vaccine_safety_update_at_end_of_4_years_routine_use_in_HPV_immunisation_programme.pdf) - [Codeine and dihydrocodeine minimising the risk of addiction](https://assets.publishing.service.gov.uk/media/5df7610c40f0b60956f5a2e4/Codeine_and_dihydrocodeine_minimising_the_risk_of_addiction.pdf) - [Combined oral contraceptives (the pill) when to start taking the pill, and missed pill advice](https://assets.publishing.service.gov.uk/media/5df7610c40f0b6095a7681a2/Combined_oral_contraceptives__the_pill__when_to_start_taking_the_pill__and_missed_pill_advice.pdf) - [Dopamine agonists pathological gambling and increased libido](https://assets.publishing.service.gov.uk/media/5df7610ced915d093931ae93/Dopamine_agonists_pathological_gambling_and_increased_libido.pdf) - [Efficacy of progestogens in the maintenance of early pregnancy in women with threatened miscarriage or recurrent miscarriage](https://assets.publishing.service.gov.uk/media/5df7610c40f0b60943263e83/Efficacy_of_progestogens_in_the_maintenance_of_early_pregnancy_in_women_with_threatened_miscarriage_or_recurrent_miscarriage.pdf) - [Finasteride risk of male breast cancer](https://assets.publishing.service.gov.uk/media/5df7610c40f0b60959adc737/Finasteride_risk_of_male_breast_cancer.pdf) - [Fluoxetine in pregnancy slight risk of heart defects in unborn child](https://assets.publishing.service.gov.uk/media/5df7610de5274a08dacf0fe4/Fluoxetine_in_pregnancy_slight_risk_of_heart_defects_in_unborn_child.pdf) - [Gadolinium-containing MRI contrast agents nephrogenic systemic fibrosis](https://assets.publishing.service.gov.uk/media/5df7610d40f0b60946e5ac92/Gadolinium-containing_MRI_contrast_agents_nephrogenic_systemic_fibrosis.pdf) - [Hormone replacement therapy (HRT) safety update](https://assets.publishing.service.gov.uk/media/5df7610ded915d093cec0914/Hormone_replacement_therapy__HRT__safety_update.pdf) - [Liquid paracetamol for children revised UK dosing instructions introduced](https://assets.publishing.service.gov.uk/media/5df7610ded915d093cec0915/Liquid_paracetamol_for_children_revised_UK_dosing_instructions_introduced.pdf) - [Epoetins for the management of anaemia associated with cancer risk of tumour progression and mortality](https://assets.publishing.service.gov.uk/media/5df7610d40f0b6094e25ac5c/MHRA_Public_Assessment_Report_Epoetins_for_the_management_of_anaemia_associated_with_cancer_risk_of_tumour_progression_and_mortality__676Kb_.pdf) - [Statins update to product safety information](https://assets.publishing.service.gov.uk/media/5df7610fed915d09360e547c/Statins_update_to_product_safety_information.pdf) - [Epoetins for the management of anaemia in patients with chronic renal disease mortality and cardiovascular morbidity](https://assets.publishing.service.gov.uk/media/5df7610de5274a08dd355bae/MHRA_Public_Assessment_Report_Epoetins_for_the_management_of_anaemia_in_patients_with_chronic_renal_disease_mortality_and_cardiovascular_morbidity.pdf) - [Neuroleptics and cardiac safety](https://assets.publishing.service.gov.uk/media/5df7610ded915d0931d7475e/Neuroleptics_and_cardiac_safety.pdf) - [Nicobrevin withdrawn from UK market as risks outweigh benefits](https://assets.publishing.service.gov.uk/media/5df7610ded915d09322e22cc/Nicobrevin_withdrawn_from_UK_market_as_risks_outweigh_benefits.pdf) - [Non-steroidal anti-inflammatory drugs (NSAIDs) cardiovascular risks](https://assets.publishing.service.gov.uk/media/5df7610ee5274a08f518e911/Non-steroidal_anti-inflammatory_drugs__NSAIDs__cardiovascular_risks.pdf) - [Oral liquid cough medicines containing codeine should not be used in those aged less than 18 years](https://assets.publishing.service.gov.uk/media/5df7610e40f0b60941ffefd8/Oral_liquid_cough_medicines_containing_codeine_should_not_be_used_in_those_aged_less_than_18_years.pdf) - [Orciprenaline sulphate (Alupent) withdrawal from UK market after a risk-benefit analysis](https://assets.publishing.service.gov.uk/media/5df7610ee5274a08f518e912/Orciprenaline_sulphate__Alupent__withdrawal_from_UK_market_after_a_risk-benefit_analysis.pdf) - [Pseudoephedrine and ephedrine managing the risk of medicines misuse 2015](https://assets.publishing.service.gov.uk/media/5df7610eed915d0933009728/Pseudoephedrine_and_ephedrine_managing_the_risk_of_medicines_misuse_2015.pdf) - [Pseudoephedrine and ephedrine managing the risk of medicines misuse](https://assets.publishing.service.gov.uk/media/5df7610eed915d093cec0917/Pseudoephedrine_and_ephedrine_managing_the_risk_of_medicines_misuse.pdf) - [Pseudoephedrine and ephedrine managing the risk of misuse - 2009 update](https://assets.publishing.service.gov.uk/media/5df7610e40f0b609455bc0da/Pseudoephedrine_and_ephedrine_managing_the_risk_of_misuse_-_2009_update.pdf) - [Pseudoephedrine and ephedrine managing the risk of misuse - 2012 review](https://assets.publishing.service.gov.uk/media/5df7610e40f0b6094267a5c4/Pseudoephedrine_and_ephedrine_managing_the_risk_of_misuse_-_2012_review.pdf) - [Pseudoephedrine and ephedrine managing the risk of misuse 2011 review](https://assets.publishing.service.gov.uk/media/5df7610ee5274a08dacf0fe5/Pseudoephedrine_and_ephedrine_managing_the_risk_of_misuse_2011_review.pdf) - [Pseudoephedrine and ephedrine managing the risk of misuse – July 2010 update](https://assets.publishing.service.gov.uk/media/5df7610e40f0b60948b2257f/Pseudoephedrine_and_ephedrine_managing_the_risk_of_misuse__U2013_July_2010_update.pdf) - [Reboxetine review of benefits and risks](https://assets.publishing.service.gov.uk/media/5df7610eed915d093931ae94/Reboxetine_review_of_benefits_and_risks.pdf) - [Reclassification of Nexium Control 20mg Gastro-Resistant Tablets](https://assets.publishing.service.gov.uk/media/5df7610ee5274a08df9dd859/Reclassification_of_Nexium_Control_20mg_Gastro-Resistant_Tablets.pdf) - [Risk of venous thromboembolism associated with antipsychotics](https://assets.publishing.service.gov.uk/media/5df7610fed915d093724a2db/Risk_of_venous_thromboembolism_associated_with_antipsychotics.pdf) - [Seasonal flu vaccines no evidence of an increased risk of febrile convulsions in children](https://assets.publishing.service.gov.uk/media/5df7610fe5274a08e81c3e5d/Seasonal_flu_vaccines_no_evidence_of_an_increased_risk_of_febrile_convulsions_in_children.pdf) - [Swine flu vaccines and antiviral medicines UK post-pandemic safety review](https://assets.publishing.service.gov.uk/media/5df76110e5274a08e626bd82/Swine_flu_vaccines_and_antiviral_medicines_UK_post-pandemic_safety_review.pdf) - [Tamoxifen reduced effectiveness when used with CYP2D6 inhibitors](https://assets.publishing.service.gov.uk/media/5df7611040f0b60941ffefdb/Tamoxifen_reduced_effectiveness_when_used_with_CYP2D6_inhibitors.pdf) - [Vigabatrin brain MRI abnormalities and movement disorders](https://assets.publishing.service.gov.uk/media/5df7610fed915d093a15d217/Vigabatrin_brain_MRI_abnormalities_and_movement_disorders.pdf) - [Warfarin changes to safety information](https://assets.publishing.service.gov.uk/media/5df76110e5274a0910cb6d46/Warfarin_changes_to_safety_information.pdf) - [α-1 adrenoceptor antagonists and intraoperative floppy iris syndrome (IFIS)](https://assets.publishing.service.gov.uk/media/5df7611040f0b6095a7681a3/_U03b1-1_adrenoceptor_antagonists_and_intraoperative_floppy_iris_syndrome__IFIS_.pdf) - [Nicotine replacement therapy harm reduction in smokers](https://assets.publishing.service.gov.uk/media/5dfb54baed915d1f0d52f74e/Nicotine_replacement_therapy_harm_reduction_in_smokers.pdf) - [Review of isotretinoin and psychiatric adverse reactions (2014) ](https://assets.publishing.service.gov.uk/media/655201b48a2ed40013720d44/Review_of_isotretinoin_and_psychiatric_adverse_reactions__2014_.pdf) - [Valproate: Paternal exposure to valproate and risk of neurodevelopmental disorders and congenital malformations in offspring](https://assets.publishing.service.gov.uk/media/66d9a078608fb761b6811128/Valproate-PAR-PASS-_accessible_-_PUBLISH.pdf)