PFD report

Alana Molly CUTLAND · Prevention of Future Deaths report

Pin Get email alerts Request correction

Issued 5 Aug 2020•Milton Keynes

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.

View original report
Concerns
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
3

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Failure of drug information leaflets to mention psychotic reactions as a possible side-effect
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.2

  1. Action

    Review available evidence on doxycycline-associated psychotic reactions and obtain expert advice on whether product information should be amended.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 19 October 2020.
  2. Action

    Request that the lead marketing authorisation holder submit a proposal to gather further data on psychotic reactions following doxycycline.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 19 October 2020.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    Available evidence does not establish a causal association between doxycycline and psychotic reactions.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 of drug information leaflets to mention psychotic reactions as a possible side-effect

Wider context from the report

“The deceased was prescribed doxycycline as an antimalarial medication for used whilst in Madagascar. It was quite apparent from the evidence that she had a psychotic reaction as a result of taking the drug and yet there is nothing on the drug information leaflet that either highlights or mentions this possibility. If she or her parents have been aware of this possible side-effect they may have been able to intervene earlier to avoid her death. In my view the information sent out with the drug should be reviewed. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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 available evidence on doxycycline-associated psychotic reactions and obtain expert advice on whether product information should be amended.

Verbatim wording from the response

“As you have noted, the product information for doxycycline does not mention psychotic reactions as a possible side effect. We have conducted a review of the available evidence concerning doxycycline and psychotic reactions and sought expert advice from the Commission on Human Medicine’s Pharmacovigilance Expert Advisory Group on the strength of the evidence and whether the doxycycline product information should reflect these events.”

Source location

2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Page 1 · response
Published 19 October 2020

Open published response

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

Request that the lead marketing authorisation holder submit a proposal to gather further data on psychotic reactions following doxycycline.

Verbatim wording from the response

“The CHM Pharmacovigilance Expert Advisory Group advised that overall, the evidence to support a causal association between doxycycline and psychotic disorder was limited considering the cumulative exposure to this drug in the UK which is likely to be in the order of tens of millions of people. The PEAG advised that prior to the possible addition of psychotic type reactions in the doxycycline product information, which may cause patient alarm, further data is needed to enable a more robust assessment. The EAG recommended that the marketing authorisation holder (MAH) for the brand-leader doxycycline product should be requested to propose how this additional data may be collected, for example by investigating the feasibility of conducting a study using electronic healthcare records which compares rates of psychotic reactions following doxycycline, with another antibiotic.”

Source location

2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Page 2 · response
Published 19 October 2020

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

Available evidence does not establish a causal association between doxycycline and psychotic reactions.

Verbatim wording from the response

“Overall, these spontaneous ADR reports provide limited evidence on which to base a thorough assessment of causality between doxycycline and psychotic reactions. While under-reporting is a common problem with spontaneous ADR reporting, given that in the context of malaria prophylaxis, doxycycline is often given to healthy people, it may be that we would expect to see more cases of a serious reaction like psychosis if it were a true ADR for doxycycline. In addition, there is no established biological mechanism to explain an association between doxycycline and clinical and psychotic reactions and there is little in the way of published literature suggesting a causal link, including a lack of any well-controlled studies.”

Source location

2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Page 2 · response
Published 19 October 2020

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

Further data is needed before psychotic reactions can be added to doxycycline product information.

Verbatim wording from the response

“The CHM Pharmacovigilance Expert Advisory Group advised that overall, the evidence to support a causal association between doxycycline and psychotic disorder was limited considering the cumulative exposure to this drug in the UK which is likely to be in the order of tens of millions of people. The PEAG advised that prior to the possible addition of psychotic type reactions in the doxycycline product information, which may cause patient alarm, further data is needed to enable a more robust assessment. The EAG recommended that the marketing authorisation holder (MAH) for the brand-leader doxycycline product should be requested to propose how this additional data may be collected, for example by investigating the feasibility of conducting a study using electronic healthcare records which compares rates of psychotic reactions following doxycycline, with another antibiotic.”

Source location

2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Page 2 · response
Published 19 October 2020

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

    Continue closely reviewing the issue of doxycycline and psychotic reactions.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 19 October 2020.

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

Continue closely reviewing the issue of doxycycline and psychotic reactions.

Verbatim wording from the response

“In the meantime, we will continue to keep the issue of doxycycline and psychotic reactions under close review.”

Source location

2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Page 2 · response
Published 19 October 2020

Open published response
Back to top

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

Data last updated 7 September 2026