Inadequate safety warnings on medication packaging
First to latest report 16 Nov 2015 — 15 Feb 2024
Reports that mention this concern
5
Times this concern has been raised
6
Stated actions linked to this concern
5
What this concern includes
Includes failures of warnings on medication bottles, packs, labels or accompanying medication information where missing, unclear or insufficiently prominent warnings could lead to unsafe medication use, including excessive dosing or other serious medication-related risks.
What is not included
Excludes warnings for non-medication products, food, chemicals, appliances or equipment unless the assertion explicitly concerns medication packaging.
Excludes medication prescribing, dispensing, administration, monitoring or counselling failures where the packaging-warning control is not deficient.
Excludes generic patient-information deficiencies that are not specifically tied to warnings on medication packaging or its accompanying medication information.
Excludes the underlying medication hazard or adverse outcome when no medication-packaging warning failure is identified.
Trends
Reports over time
Reports mentioning this concern, over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
Department of Health and Social Care3
Medicines and Healthcare products Regulatory Agency3
Advanced Health And Care Limited1
Association of Ambulance Chief Executives1
Bausch & Lomb U.K. Limited1
BNF Publications1
Boehringer Ingelheim Limited1
London Ambulance Service NHS Trust1
London Central & West Unscheduled Care Collaborative Limited1
National Institute for Health and Care Excellence1
NHS Enfield Clinical Commissioning Group1
NHS England1
NHS West and North London Integrated Care Board1
Teva Pharmaceutical Industries Ltd1
Teva UK Limited1
Medicines and medical devices regulator3
Ministerial department3
Private limited company3
Clinical commissioning group1
Executive non-departmental public body1
Healthcare site1
Health-sector membership body1
Independent healthcare provider1
Integrated care board1
NHS trust1
Sub-organisation1
Type not available1
Reports and published responses 5 reports
See individual reports that have raised this concern, and the actions taken in response
County Durham and Darlington
Concerns raised1
Failure of clozapine packaging and leaflets to warn that combined use with alcohol may cause death
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Linked responses
Department of Health and Social Care
Medicines and Healthcare products Regulatory Agency
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Medicines and Healthcare products Regulatory Agency
Conduct a further assessment of clozapine product information on drug-drug interactions and consider improvements for healthcare professionals, patients, families and carers.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Department of Health and Social Care
MHRA is responsible for assessing and potentially improving clozapine product information about drug interactions and associated safety risks.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Swansea and Neath Port Talbot
Concerns raised1
Lack of immediate, prominent medication warnings about increased suicidal thinking risk in young adults
Linked responses
Department of Health and Social Care
Medicines and Healthcare products Regulatory Agency
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Medicines and Healthcare products Regulatory Agency
Implement and user-test prominent SSRI patient-information warnings about suicidal thoughts and behaviour.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Medicines and Healthcare products Regulatory Agency
Current UK headlines and emboldened patient-information warnings are considered sufficient because no evidence shows US black-box warnings communicate risk more effectively.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Department of Health and Social Care
The MHRA has found no evidence that United States-style black-box warnings communicate medicine risks more effectively than UK patient information leaflets.
Disputes the concernThe respondent disagreed with part of the concern or the basis for it.
Department of Health and Social Care
Existing NICE, product information, BNF and MHRA guidance is considered adequate to inform SSRI risk discussions and monitoring, particularly when treatment begins.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Inner North London
Concerns raised1
Failure to display the advice to carry two adrenaline auto injectors on the outside of the box
This report raised 20 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
Bausch & Lomb U.K. Limited
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Bausch & Lomb U.K. Limited
Initiate discussions with MHRA about adding advice to outer packaging that patients should carry two adrenaline auto-injectors.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Bausch & Lomb U.K. Limited
Changes to medicinal-product labelling require approval from the competent regulatory authority under the Human Medicines Regulations 2012.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
West Sussex
Concerns raised2
Lack of bottle warnings about unmeasured or excessive dosing
Insufficient leaflet warnings about taking an excess dose
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
Boehringer Ingelheim Limited
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2
Boehringer Ingelheim Limited
Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.
Boehringer Ingelheim Limited
Request MHRA approval to add an explicit warning against drinking Oramorph directly from the bottle and describe overdose risks in the patient information leaflet.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.5
Boehringer Ingelheim Limited
Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Boehringer Ingelheim Limited
Existing bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Boehringer Ingelheim Limited
Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Boehringer Ingelheim Limited
Prescribing clinicians and other healthcare professionals are responsible for explaining dosing, risks, and consequences of exceeding prescribed doses.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Boehringer Ingelheim Limited
The existing Patient Information Leaflet sufficiently warns about excess-dose symptoms, risks, required medical help, and possible death, so no further action was taken.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Manchester North
Concerns raised1
Inadequate packaging warnings about the consequences of using damaged Fentanyl patches
Linked response
Takeda UK Limited
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Takeda UK Limited
The current Matrifen leaflet adequately addresses the risk of damaged patches.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Takeda UK Limited
The brand leader manufacturer was asked to review whether product information changes were required.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Actions and positions describe what organisations say in published responses. Implementation is not independently verified.
Actions and positions describe what organisations say in published responses. Implementation is not independently verified.