PFD report

Charles Hugh Rendell · Prevention of Future Deaths report

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Issued 11 Jan 2017•Berkshire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
5

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised2

  1. Failure to clearly communicate ciprofloxacin’s potential psychiatric and suicidal effects to patients
    Part of recurring concern: Failure to communicate clinically significant medication risks to patients
  2. Failure to ensure prescribing clinicians are sufficiently aware of ciprofloxacin’s potential psychiatric and suicidal effects
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 recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. Action

    Review all UK package leaflets for generic ciprofloxacin products for consistent presentation of the identified safety information.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 19 February 2017.
  2. Action

    Keep Bayer’s product information for its medicines under constant review.

    Stated by Bayer plcStated in progressThe respondent said that this action was in progress when they made their response on 19 February 2017.
  3. Action

    Examine New Zealand Ciproxin product information to verify warnings about possible suicidal behaviour for prescribers and patients.

    Stated by Bayer plcStated completedThe respondent said that this action was complete when they made their response on 19 February 2017.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    Existing Ciproxin product information is comprehensive and up to date on psychiatric risks and advises immediate contact with the prescriber.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do 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. ”

Is this part of a recurring concern?

Yes — Failure to communicate clinically significant medication risks to patients.

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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. Response links show a clear evidence connection; they do 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. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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 all UK package leaflets for generic ciprofloxacin products for consistent presentation of the identified safety information.

Verbatim wording from the response

“We will review all the UK Package Leaflets for generic ciprofloxacin products to ensure that the information mentioned above is consistently presented across these products.”

Source location

2017-0006-Response-by-MHRA
Page 2 · response
Published 19 February 2017

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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
Page 7 · response
Published 19 February 2017

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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
Page 6 · response
Published 19 February 2017

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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
Page 7 · response
Published 19 February 2017

Open published response

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 Ciproxin product information is comprehensive and up to date on psychiatric risks and advises immediate contact with the prescriber.

Verbatim wording from the response

“In light of the above, we consider that the product information for Ciproxin provides comprehensive, up-to-date information on the risk of mental disturbances including agitation, confusion, psychosis, depression, suicidal ideation and the possibility of completed suicide. In addition, there is clear advice on the need for immediate contact with the prescribing doctor, should these undesirable effects occur whilst taking Ciproxin.”

Source location

2017-0006-Response-by-MHRA
Page 2 · response
Published 19 February 2017

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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
Page 6 · response
Published 19 February 2017

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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
Page 7 · response
Published 19 February 2017

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. 1

    Review reports of psychiatric effects, including attempted and completed suicide, associated with ciprofloxacin.

    Stated by Bayer plcStated completedThe respondent said that this action was complete when they made their response on 19 February 2017.

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 reports of psychiatric effects, including attempted and completed suicide, associated with ciprofloxacin.

Verbatim wording from the response

“As a preliminary matter, please be aware that patient safety is taken very seriously by Bayer. After receiving notification of Mr Rendell’s death and the associated circumstances, we have carefully reviewed all reports of psychiatric effects, specifically attempted and completed suicide associated with use of ciprofloxacin. The review included all sources of information available to us. We have considered these in the context of the information currently provided to prescribers and to patients and the matters raised in your report.”

Source location

2017-0006-Response-by-Bayer-PLC
Page 1 · response
Published 19 February 2017

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026