29 May 2018 Brian Leonard Bicat · Prevention of Future Deaths report West Yorkshire (Western)
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Concerns raised 6 Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases View source Lack of accurate national data on fire incidents involving paraffin-based skin products View source Inconsistent fire-risk alerts and warnings across NHS prescribing systems View source Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams View source Failure to display fire-risk warnings on all product packaging View source Fire hazard from paraffin-based ointments and low-paraffin emollient creams View source See 3 more concerns
Responses linked to these concerns
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No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Brian Leonard Bicat · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases
Wider context from the report “Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Lack of accurate national data on fire incidents involving paraffin-based skin products
Wider context from the report “Consider a review of the current effectiveness of obtaining fire incident reports involving paraffin based skin products since there is currently a lack of accurate national data involving paraffin based skin products
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Inconsistent fire-risk alerts and warnings across NHS prescribing systems
Wider context from the report “The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG’s resulting inconsistent alerts and warnings .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams
Wider context from the report “Health care professionals in both hospital and community setting may not be aware of the potential fire hazard poised by emollient creams which contain a low level of paraffin
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Failure to display fire-risk warnings on all product packaging
Wider context from the report “Warnings of such risks are not displayed on all product packaging
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Fire hazard from paraffin-based ointments and low-paraffin emollient creams
Wider context from the report “Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk
” Open source report
11 Jan 2017 Charles Hugh Rendell · Prevention of Future Deaths report Berkshire
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Concerns raised 2 Failure to clearly communicate ciprofloxacin’s potential psychiatric and suicidal effects to patients View source Failure to ensure prescribing clinicians are sufficiently aware of ciprofloxacin’s potential psychiatric and suicidal effects View source
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Charles Hugh Rendell · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Charles Hugh Rendell, aged 76, underwent a prostate biopsy and was prescribed Ciprofloxacin before being found hanging in a garage on 24 September 2016. The Inquest concluded that he took his own life. The report raises concern that Ciprofloxacin’s potential psychiatric and suicide-related risks, and the symptoms requiring attention, may not be sufficiently communicated to patients and prescribing clinicians.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Failure to clearly communicate ciprofloxacin’s potential psychiatric and suicidal effects to patients
Wider context from the report “(2) Ciprofloxacin carries warnings/precautions that, in rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. However, it is unclear how clearly this is made known to Ciprofloxacin users .
(3) The literature suggests that this type of side effect can occur even soon after commencing Ciprofloxacin at a comparatively low dose. As it is an antibiotic, there is no compelling reason why patients should expect to have this effect unless this fact, and potential symptoms, are brought clearly to their attention by prescribing clinicians .
(4) One of Mr Rendell’s family members is a general practitioner in New Zealand. At the Inquest, she advised that she had no knowledge of the potential effect of Ciprofloxacin and, in conversation with her colleagues, nor did they. I am therefore concerned that this potential risk has not been given sufficient emphasis and that consideration should be given to prescribing clinicians highlighting the symptoms and suggesting to patients that they are alert of the possibility and react appropriately.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bayer plc; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure prescribing clinicians are sufficiently aware of ciprofloxacin’s potential psychiatric and suicidal effects
Wider context from the report “(2) Ciprofloxacin carries warnings/precautions that, in rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. However, it is unclear how clearly this is made known to Ciprofloxacin users.
(3) The literature suggests that this type of side effect can occur even soon after commencing Ciprofloxacin at a comparatively low dose. As it is an antibiotic, there is no compelling reason why patients should expect to have this effect unless this fact, and potential symptoms, are brought clearly to their attention by prescribing clinicians.
(4) One of Mr Rendell’s family members is a general practitioner in New Zealand. At the Inquest, she advised that she had no knowledge of the potential effect of Ciprofloxacin and, in conversation with her colleagues, nor did they . I am therefore concerned that this potential risk has not been given sufficient emphasis and that consideration should be given to prescribing clinicians highlighting the symptoms and suggesting to patients that they are alert of the possibility and react appropriately.
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Keep Bayer’s product information for its medicines under constant review.
Verbatim wording from the response “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.” Source location 2017-0006-Response-by-Bayer-PLC
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Examine New Zealand Ciproxin product information to verify warnings about possible suicidal behaviour for prescribers and patients.
Verbatim wording from the response “Following receipt of your report however we have examined the New Zealand Data Sheet and CMI for Ciproxin and can confirm that they both contain warnings about the possible risk of suicidal behaviour, directed towards prescribing healthcare professionals and patients respectively.” Source location 2017-0006-Response-by-Bayer-PLC
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review UK product information issued by generic ciprofloxacin manufacturers for adequacy of warnings about suicidal behaviour.
Verbatim wording from the response “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.” Source location 2017-0006-Response-by-Bayer-PLC
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The content of a generic New Zealand ciprofloxacin product's information cannot be altered because it is controlled by another manufacturer.
Verbatim wording from the response “In contrast, the document which you provided and which was, seemingly, supplied to you by the relative of Mr Rendello who is a general practitioner in New Zealand, is a Data Sheet for a generic version of ciprofloxacin supplied in New Zealand by Multichem NZ Limited (i.e. a formulation of ciprofloxacin that is not manufactured or supplied by Bayer). Bayer does not control the content of the information produced by Multichem. It is relevant that the information contained in this document is less detailed than that in the product information supplied by Bayer in relation to Ciproxin (whether in” Source location 2017-0006-Response-by-Bayer-PLC
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing UK and New Zealand product information adequately warns prescribers and patients about suicidal behaviour risks, so greater prominence is not appropriate.
Verbatim wording from the response “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.” Source location 2017-0006-Response-by-Bayer-PLC
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations