First reported 16 Nov 2015•Latest report 15 Feb 2024
Definition
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.
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.
Reports
5
Distinct published reports
Individual concerns
6
A report can raise multiple concerns
Date range
2015–2024
First to latest report issue date
Stated actions
5
Described in published responses
Reports over time
Reports 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
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
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.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Conduct a further assessment of clozapine product information on drug-drug interactions and consider improvements for healthcare professionals, patients, families and carers.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 22 February 2024.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
MHRA is responsible for assessing and potentially improving clozapine product information about drug interactions and associated safety risks.
Stated by Department of Health and Social CareRedirects 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
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Implement and user-test prominent SSRI patient-information warnings about suicidal thoughts and behaviour.
Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Position
Current UK headlines and emboldened patient-information warnings are considered sufficient because no evidence shows US black-box warnings communicate risk more effectively.
Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
The MHRA has found no evidence that United States-style black-box warnings communicate medicine risks more effectively than UK patient information leaflets.
Stated by Department of Health and Social CareDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Position
Existing NICE, product information, BNF and MHRA guidance is considered adequate to inform SSRI risk discussions and monitoring, particularly when treatment begins.
Stated by Department of Health and Social CareExisting 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.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Initiate discussions with MHRA about adding advice to outer packaging that patients should carry two adrenaline auto-injectors.
Stated by Bausch & Lomb U.K. LimitedStated plannedThe respondent said that this action was planned when they made their response on 13 August 2020.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
Changes to medicinal-product labelling require approval from the competent regulatory authority under the Human Medicines Regulations 2012.
Stated by Bausch & Lomb U.K. LimitedRedirects 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.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2
Action
Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.
Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
Action
Request MHRA approval to add an explicit warning against drinking Oramorph directly from the bottle and describe overdose risks in the patient information leaflet.
Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.5
Position
Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.
Stated by Boehringer Ingelheim LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Existing bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.
Stated by Boehringer Ingelheim LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.
Stated by Boehringer Ingelheim LimitedRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Prescribing clinicians and other healthcare professionals are responsible for explaining dosing, risks, and consequences of exceeding prescribed doses.
Stated by Boehringer Ingelheim LimitedRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
The existing Patient Information Leaflet sufficiently warns about excess-dose symptoms, risks, required medical help, and possible death, so no further action was taken.
Stated by Boehringer Ingelheim LimitedExisting 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
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
The current Matrifen leaflet adequately addresses the risk of damaged patches.
Stated by Takeda UK LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
The brand leader manufacturer was asked to review whether product information changes were required.
Stated by Takeda UK LimitedRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
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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.
