Amgen Limited

Private and voluntary organisations · Private limited company

Pin Request correction

First report 8 May 2019•Latest report 8 May 2019

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

* 2026 is projected from reports observed to 7 Sep 2026.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
2

Described in responses

Concerns and recipient responses

Statements from Amgen Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. Inner South London

    AI-generated summary

    Mr Edward Hearn · 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

    Mr Edward Hearn died in hospital after a cardiac arrest, with the medical cause of death including sepsis, bronchopneumonia and multiple myeloma treated with chemotherapy. The report identified concerns that a high globulin result was not followed up, that he was discharged without a safe care plan to minimise fall risk during chemotherapy, and that cardiac monitoring requirements for Carfilzomib may not have been sufficiently definitive.

    Read the report on judiciary.uk

    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 Amgen Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Lack of definitive cardiac-monitoring requirements in Carfilzomib prescribing information

    Wider context from the report

    “2. The expert pharmaceutical physician gave a recommendation that the need for cardiac monitoring was made more definitive in the drug prescribing information for Carfilzomib (and possibly others), which was prescribed in the Cardamon Trial. ”
    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 Amgen Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of laboratory abnormal-result repeating, alerting and follow-up

    Wider context from the report

    “1. The finding of a high globulin by a laboratory from a blood test in A&E was not followed up by either the laboratory or A&E department. It was not in College guidelines of tests which required urgent notification. It was indicative of a fatal disease, which was not diagnosed for approximately another 4 months. I accept the professional opinion of the haematologist that this was a system failure, which is not acknowledged by the Trust. The laboratory suggested an additional action to have an automated comment but that would still not deal with the problem of reports returning to physicians in secondary care. Evidence was heard that there is inconsistency in laboratory repeating and alerting of clinicians even between hospitals in the jurisdiction, and insufficient evidence of a safe system within the Trust. ”
    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

    Continue evaluating SmPC guidance on cardiac monitoring for Kyprolis.

    Verbatim wording from the response

    “We therefore consider that cardiac monitoring guidance is already definitively outlined in the prescribing information for Kyprolis. As the guidance provided in the current SmPC has been approved by PRAC and EMA, we believe that no further revisions to the SmPC are required. We will however, continue to conduct ongoing pharmacovigilance for Kyprolis and to evaluate our SmPC guidance on cardiac monitoring, in accordance with all pharmacovigilance requirements.”

    Source location

    Response from AMGEN
    Page 2 · response
    Published 8 May 2019

    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 prescribing information definitively outlines cardiac monitoring guidance, so no further SmPC revisions are required.

    Verbatim wording from the response

    “We therefore consider that cardiac monitoring guidance is already definitively outlined in the prescribing information for Kyprolis. As the guidance provided in the current SmPC has been approved by PRAC and EMA, we believe that no further revisions to the SmPC are required. We will however, continue to conduct ongoing pharmacovigilance for Kyprolis and to evaluate our SmPC guidance on cardiac monitoring, in accordance with all pharmacovigilance requirements.”

    Source location

    Response from AMGEN
    Page 2 · response
    Published 8 May 2019

    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

    A unilateral SmPC update based on one case is not possible because extensive medical evidence and stakeholder examination are required.

    Verbatim wording from the response

    “We take all adverse event (“AE”) reporting very seriously at Amgen. Governance processes, both internally at Amgen and at European Medicines Agency (“EMA”) and Pharmacovigilance Risk Assessment Committee (“PRAC”) level, mandate that AE data, such as in this case, is evaluated on a regular basis to establish the benefit risk profile of authorised medicinal products and determine whether adjustments are needed in the Summary of Product Characteristics (“SmPC”) and Patient Information Leaflet (“PIL”). The labeling process in the EU is a collaboration between the agency (EMA/PRAC) and the MAH. A unilateral update to the SmPC based on one case alone, would not therefore be possible as examination of extensive medical evidence by all stakeholders would be required prior to any SmPC change being implemented.”

    Source location

    Response from AMGEN
    Page 1 · response
    Published 8 May 2019

    Open published response
Back to top

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

Data last updated 7 September 2026