Medical Product Allergen Labelling
67 items
2 sources
Unclear labelling, inconsistent nomenclature, and insufficient research regarding allergens in medical products.
Cross-Source Insight
Medical Product Allergen Labelling has been flagged across 2 independent accountability sources:
1 inquiry rec
66 PFD reports
This issue has been identified by multiple independent accountability bodies, suggesting it is a recurring systemic concern.
PFD Reports (66)
Clive Hyman
Concerns: Patient information leaflets for Apixaban do not adequately advise on actions following head trauma, risking delayed medical intervention for intracranial bleeds in patients taking anticoagulants.
Overdue
Venetia Pierce
Concerns: An EMIS system failed to flag a nitrofurantoin safety alert because it only triggered for pre-existing conditions, alongside generally low clinician awareness of the drug's pulmonary risks in the elderly.
Overdue
Liliwen Thomas
Concerns: Over-administration of analgesia during labour rendered the mother comatose, masking labour progression, and current national guidelines lack explicit detail on safe analgesia levels and supervision.
Responded
Chloe Burgess
Concerns: The severe interaction between amitriptyline, paroxetine, and ivabradine is poorly understood, not flagged by prescribing software, and prescribers lack full awareness, posing a significant toxicity risk.
Responded
Philip Jones
Concerns: Denture adhesive gel poses an unadvertised choking hazard, particularly for vulnerable elderly individuals, and lacks essential warnings on its packaging or leaflet about this significant risk.
Responded
Carla James
Concerns: Products are being imported and sold without adequate warnings about their highly poisonous and toxic nature, posing a serious risk to life.
Responded
Susan Karakoc
Concerns: Search engines readily return websites selling addictive prescription medications, indicating a failure in monitoring online supply chains and detecting criminal financial enterprises.
Overdue
Hannah Jacobs
Concerns: Dental staff failed to recognise anaphylaxis symptoms, and allergy plans gave false reassurance for mild reactions. Education is needed on identifying anaphylaxis and using adrenaline auto-injectors if in doubt.
Responded
Sasha Drysdale
Concerns: Further research is needed to confirm or refute whether Clozapine materially increases the risk of patients developing certain blood cancers, given international study suggestions.
Responded
Alexander Reid
Concerns: An incorrect BMI entry in GP records led to the deceased being wrongly identified as vulnerable for early COVID-19 vaccination. The system lacked validation rules to challenge such data errors, contributing to his death.
Responded
David Mitchener
Concerns: Food labelling requirements are inadequate, failing to include warnings, guidance on dosage, and potential serious risks and side effects of excess vitamin supplements.
Responded
Bobby Lee
Concerns: A significant rise in fires from faulty e-bike/e-scooter lithium-ion batteries and unsuitable chargers, often from inferior conversion kits and unregulated online sales, highlights the lack of specific safety standards.
Responded
Frederick Le Grice
Concerns: Patients and clinicians lack awareness regarding the serious lung damage risk from Nitrofurantoin. Current guidance is insufficient to ensure vigilance for symptoms and regular respiratory monitoring.
Responded
Rohan Godhania
Concerns: High protein supplements lack adequate warning labels for individuals with undiagnosed urea cycle disorders, risking severe medical emergencies due to sudden protein intake.
Responded
Robert Stevenson
Concerns: Prescribing doctors may be unaware of a rare potential link between Ciprofloxacin/Quinolone antibiotics and suicidal behaviour, especially in depressed patients. Guidelines should be reviewed to increase awareness and mitigate this risk.
Overdue
Joshua Asprey
Concerns: Inconsistency between Sertraline's patient leaflet and the British National Formulary regarding suicidal behaviour side effects risks medical practitioners being unaware of, or not discussing, this potential risk with patients.
Responded
John Roberts
Concerns: A hospital inadvertently reduced a critical steroid dosage without informing the patient or GP. Additionally, national guidance (BNF/NICE) for Prednisolone lacks crucial information on bowel perforation risk for diverticular disease patients.
Responded
Angela Kearn
Concerns: Medical profession lacks awareness of Immersion Pulmonary Oedema. Full face snorkel masks have inadequate safety standards and insufficient public warnings regarding risks for users with cardiovascular/respiratory conditions.
Overdue
Celia Marsh
Concerns: The investigation of suspected anaphylaxis deaths is hampered by outdated pathology guidance, poor sample retention, delayed reporting, and insufficient education for medical staff and high-risk patients. There's also a lack of robust systems to capture anaphylaxis cases.
Responded
Susan Skillen
Concerns: Patient information for methotrexate lacks crucial warnings about the rare but serious side effect of phototoxicity, requiring a review of literature and adverse event reporting.
Overdue
Jane Allison
Concerns: The BNF content for Nitrofurantoin was deficient in advising on monitoring for sudden pulmonary deterioration in elderly, active patients, even for short treatment courses.
Responded
Samantha Singh
Concerns: A patient's RAST test results were wrongly categorised as normal, leading to delayed action. Subsequently, only one EpiPen was prescribed against NICE guidance, and no allergy clinic referral or follow-up was offered.
Overdue
Andrew Cook
Concerns: Concerns involve potential under-reporting of PEG allergy, insufficient research into its effects, and the lack of clear labelling on medical products regarding PEG's presence, dose, and various synonyms.
Responded
Samuel Morgan
Concerns: Patient information leaflets for SSRIs lack immediate, high-impact warnings, such as a "Black Box Warning," to clearly highlight the increased risk of suicidal thinking in young adults.
Responded
Alana Cutland
Concerns: The drug information leaflet for doxycycline failed to highlight the possibility of a psychotic reaction, which the deceased experienced, hindering early intervention by her family.
Responded
Mary Nelson
Concerns: Dangerous fluoxetine accumulation suggests a need to revise dosage guidance, especially for the elderly, and consider in-life drug testing. This death was also not reported to the Yellow Card system.
Overdue
Maureen Waterfall
Concerns: There is no licensed antidote for Edoxaban anticoagulant, increasing risks for head injury patients. Concerns were raised about the lack of national guidance on antidote administration targets and storage, especially for non-tertiary hospitals.
Overdue
Katherine Stamp
Concerns: The serious side effects of clozapine, particularly regarding smoking and pneumonia, are under-appreciated by prescribers and not sufficiently detailed in national guidance.
Overdue
Victor Hall
Concerns: Ambiguous medication packaging contributed to an error, which the MHRA failed to address. There's a need for enhanced guidance and training for nursing and pharmacy staff on thorough medication checks and documentation at all stages.
Overdue
Owen Carey
Concerns: The restaurant's allergen training was inadequate, notices on menus lacked prominence to trigger discussions, and menus failed to clearly state key allergen information, creating false reassurance for customers.
Responded
Ronald Clark
Concerns: Stents supplied in identical packaging with only small labels pose a risk of using incorrect sizes during medical procedures.
Overdue
Natasha Ednan-Laperouse
Concerns: Pret-a-Manger had inadequate allergen labelling and no robust system to monitor allergic reactions. Additionally, Epipen's needle length and adrenaline dose were identified as dangerously insufficient for adult anaphylaxis.
Responded
Stephen Whitehead
Concerns: The absence of a national registry for biliary stents creates a risk of "forgotten stents," while national guidelines lack a clear definition of "short-term" use.
Responded
Venkata Kagga
Concerns: Critical safety features for button batteries in household devices are lacking, and national safety alerts are not effectively sustained. Hospital policies for paediatric assessment and compliance were not followed, exacerbated by poor information sharing across services.
Overdue
Margaret Clark
Concerns: A change to new TOE probe sheaths (Ecolab) was linked to multiple fatal oesophageal tears, and these potentially unsafe sheaths may still be in use in other hospitals despite safer alternatives existing.
Responded
Michael Spencer
Concerns: A specific drug (Andexanet alfa) to reverse potentially fatal bleeding caused by Factor Xa inhibitor anticoagulants is not available in the UK, even for compassionate use.
Overdue
Christina Fletcher
Concerns: A lack of clear regulatory guidance on 'red flag' systems for pharmacies to identify patients with similar details and inconsistent chain of custody protocols for controlled drugs pose risks.
Overdue
Pauline Taylor
Concerns: Emollient creams with paraffin pose an unrecognised fire hazard due to inadequate warnings and lack of awareness, alongside insufficient patient risk assessments.
Overdue
Grace Roseman
Concerns: Crib manufacturer failed to fully address the risk of death from an un-modified crib design, leaving a large number of potentially unsafe products in circulation with unaware customers.
Responded
Marjorie Bassendine
Concerns: Failure to recognise the cardiac risks of multiple psychotropic medications led to a lack of pre-treatment and regular ECGs to monitor for potential QT interval prolongation.
Overdue
Zane Gbangbola
Concerns: Inadequate and misleading safety guidance for internal combustion engine equipment used in confined spaces, coupled with the misleading use of the HSE logo, increases the risk of harm.
Overdue
Dildar Shariff
Concerns: There is a critical lack of national awareness and NICE guideline inclusion regarding the increased haemorrhage risk in haemodialysis or uremia patients, potentially leading to future deaths.
Overdue
Samantha Hopkins
Concerns: Critical trial exclusions, such as for pregnant women, were overlooked due to insufficient prominence on drug packet warnings and lack of guidance for highlighting these exclusions.
Responded
Jonathan Weatherley
Concerns: Recall notices for the products were inadequate, failing to highlight all known problems and affected items, necessitating a comprehensive, widely distributed new recall.
Overdue
Kathryn Bull
Concerns: Death was caused by hyperammonaemia syndrome, a rare and poorly understood adverse consequence of gastric bypass surgery, with symptoms that are not well known.
Overdue
Christopher Holyoake
Concerns: E45 cream, a highly flammable paraffin-based product, lacked fire hazard warnings on its packaging and prescription, leading to a dangerous lack of awareness among carers and the deceased.
Overdue
Rubana Pathan
Concerns: Medical professionals and implant manufacturers lack awareness that a rare toxin causing sepsis can suppress typical inflammation signs, potentially delaying diagnosis and treatment for patients with breast implants.
Overdue
Patricia Thomas
Concerns: A significant lack of awareness among health professionals regarding the dangerous interaction between Miconazole Gel and Warfarin, combined with unclear information resources, risks uncontrolled bleeding.
Overdue
Irene Pearson
Concerns: Matrifen patch warnings about hot baths are obscure and vague, and dangerous advice was given to use baths for patch removal. Poor liaison on opiate prescribing and unclear, scanty GP electronic notes contributed to unsafe care.
Overdue
Nadine Brookes-Walker
Concerns: Packaging for Fentanyl patches may not adequately convey the severe risks associated with using damaged patches, potentially leading to patient misuse.
Responded
Dilys Jenkins
Concerns: Tracheostomy tube manufacturers may not be keeping pace with population changes, leading to tubes of potentially inappropriate length which could increase dislodgement risk.
Overdue
Stephen Myers
Concerns: A product containing isopropyl nitrite, misused by inhalation, has inadequate labelling that fails to comply with current safety regulations (CLP) regarding hazards and warnings.
Overdue
Julie McCabe
Concerns: The hair colourant industry's reliance on "spontaneous reports" significantly underestimates allergic reactions to PPD, creating a massive disconnect with independent research on consumer safety.
Overdue
Brian Marks
Concerns: PEJ and PEG tubes are easily confused due to their similar appearance, highlighting the lack of a simple colour-coding system for differentiation.
Responded
Annette Charlton
Concerns: Pharmaceutical manufacturers are producing medications in almost identical packaging, which significantly increases the risk of dispensing errors and poses a serious threat to patient safety.
Overdue
James Fyfe
Concerns: The cot side on a trolley could remain in an unlocked position due to design and maintenance issues, which were not clearly highlighted. The MHRA failed to escalate this known hazard to other hospital trusts.
Responded
Patricia Mellor
Concerns: Despite detailed recommendations from a hospital regarding Long QT Syndrome and drug-related cardiac arrest risks during anaesthesia, regulatory bodies (MHRA, NICE) have failed to update guidelines and product warnings.
Overdue
Tiya Chauhan
Concerns: Childcare settings and parents are unaware of the choking risks posed by raw jelly cubes, with packets lacking adequate warnings and supervision during play being insufficient.
Responded
George Stone
Concerns: National guidelines for antidepressant warnings, specifically for Venlafaxine, fail to include the rare but severe risk of seizures, potentially leaving patients uninformed about a critical side effect.
Overdue
Archie Hames
Concerns: The combined use of a specific tracheostomy tube and a particular Velcro strap attachment compromised the tube's integrity, likely causing detachment and posing risks with similar devices.
Overdue
Dafydd Watts
Concerns: Drug literature and the British National Formulary fail to adequately inform physicians about rare but potential fatal occurrences associated with medication.
Overdue
Victoria Meppen-Walter
Concerns: Concerns were raised regarding the easy online availability and regulation of chloroquine, along with the associated risks of its misuse.
Overdue
Jackie Scott
Concerns: Lack of clear allergen information meant the deceased unknowingly consumed peanuts in a take-away meal, resulting in a fatal anaphylactic shock.
Overdue
Leo Deady
Concerns: A significant proportion of breech presentations go undiagnosed nationally, yet there are no national guidelines for routine late-pregnancy scans to detect them, despite high risks.
Response: The Department of Health, following consultation with the RCOG and review of existing research, concludes there is no benefit to developing a national system of routine late-pregnancy scanning. However, the …
Overdue
William Andrews
Concerns: Surgical equipment design flaws, including the lack of a brightly coloured detachable cap on a bulb syringe, led to a retained tip. A national safety recommendation for such caps was ignored, and no cap counting procedure exists.
Response: The Medicines and Healthcare Regulatory Authority (MHRA) has engaged with the syringe manufacturer, who will now supply syringes without caps, has issued a safety notice to all UK customers, and …
Overdue
John James Jackson
Concerns: An energy mint product contained dangerously high caffeine levels without adequate warnings or information on its packaging or online, posing a risk when consumed like sweets.
Overdue