This section provides a list of UK spontaneous adverse drug reaction (ADR) reports based on articles from the scientific literature. The list is updated daily and provides the MHRA ADR reference numbers, patient age and sex, suspect drug and literature reference. Please note that if there is more than one suspect drug then the same row will be duplicated for each suspect drug classified. The list will be updated with new literature ADRs received each weekday afternoon.
In this section...
It is important to note that this list is not intended to provide a reconciled list of master numbers for each ADR reported in a literature article. Instead it is to help inform a marketing authorisation holder (MAH) that an ADR report has already been submitted for a particular literature article.
Duplicate entries will appear to be present in the list for two reasons:
- these reports have not yet been passed into the MHRA duplicate detection process as are published on the website at an early a stage as possible
- literature articles may contain ADRs for more than one patient which may appear to duplicate the literature article.
Process to follow
This list should be used to screen ADRs from literature articles which are about to be submitted to the MHRA. The following process should be followed:
- Once a literature article reporting an ADR is identified, this should be entered onto the into the marketing authorisation holder’s (MAH’s) pharmacovigilance system for collection and collation of ADR reports.
- Before submission of an expedited report to the MHRA, open the Excel file.
- Check the literature reference in the company report against the literature references.
- If the literature article and patient details can already be identified in the list, the company report should not be forwarded to the MHRA. The MHRA ADR reference should be added to the company ADR documentation and a record added that the ADR has been located on the MHRA literature ADR list with date.
- If the literature article and patient cannot be identified in this list, the ADR should be submitted to the MHRA as per the reporting requirements defined in Volume 9A.
Notes:
This process is designed to reduced the amount of duplicate reporting to the MHRA of ADR reports identified in the scientific literature. It is still expected that MAHs undertake literature searching activities for the purpose of identifying individual case safety reports (ICSRs) and safety information relevant for ongoing safety monitoring activities and Periodic Safety Update Report (PSUR) production. During pharmacovigilance inspections, the MAH will be expected to demonstrate how they meet the requirements for undertaking these activities.
Literature ADRs received by the MHRA 
(2067Kb)
If you have any queries please contact the Pharmacovigilance Service Desk:
pharmacovigilanceservice@mhra.gsi.gov.uk
Top tips
We have produced a top tips guide to using the literature ADRs spreadsheet for searches relevant to your company’s drugs.
Top tips for using the literature ADRs spreadsheet
(317Kb)
Contact telephone numbers
MA holders A-L: 020 3080 6550
MA holders M-S: 020 3080 6153
MA holders T-Z: 020 3080 7730
