FOI release

Freedom of Information request on yellow Card reports for Parentrovite and Pabrinex products over time including reaction type and route of administration, specifically for intramuscular and intravenous routes of administration. ( FOI 22/498)

Published 1 June 2022

FOI 22/498

18th March 2022

Dear Mr Quelch,

Thank you for your email dated 24th February 2022, where you requested all Yellow Card reports for Parentrovite and Pabrinex products over time including reaction type and route of administration, specifically for intramuscular and intravenous routes of administration.

Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request has been provided as category 1b. For this FOI, the line listings contain the following fields:

• Patient age categories (as aggregated data)

• Patient sex categories (as aggregated data)

• Suspect drug(s)

• Dose of suspect drug(s)

• Route of administration of suspect drug(s)

• Suspected adverse drug reaction(s)

• Adverse drug reaction outcome(s)

• Time to onset

• Past medical history

In response to your request I can confirm that the MHRA has received 156 UK spontaneous suspected Adverse Drug Reaction (ADR) reports associated with Pabrinex and 72 UK spontaneous suspected ADR reports of Parentrovite, for intravenous or intramuscular routes of administration up to and including 14th March 2022. The requested information can be found in Table 1a for Pabrinex and Table 2a for Parentrovite. Aggregated data for patient age and sex data can be found in Tables 1b and 1c for Pabrinex, and in Tables 2b and 2c for Parentrovite, respectively. Additionally, any blank cells within the tables are fields which have not been provided to us by the reporter as some fields on a Yellow Card form are not mandatory.

When considering the attached spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug, and are reported via the

• Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the drug. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• • It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug.

It is very important that this information is not interpreted as a list of possible side effects, nor should these data to be used to estimate the frequency of side effects. For a list of the known, possible side effects and the frequency please refer to the Patient Information Leaflet (PIL) or the Summary of medicinal Products Characteristics (SmPC) for healthcare professionals. These documents can be accessed on the MHRA website http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/ which is available to all patients, doctors and pharmacists.

I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA during this process and provide a copy of the report.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Copyright notice

• • The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.