Freedom of Information request (FOI 22/977)
Published 17 January 2024
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17th October 2022
FOI 22/977
Dear
Thank you for your FOI request dated 16th September 2022 whereby you requested:
• Any information you may hold for ferrous fumarate tablets regarding the incidents reported on Yellow Card website (by year and severity)
• How many prescriptions was issued per year in last 10 years in UK
Regarding your first point, please see the below Table 1 which illustrates the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received directly by the MHRA associated with ferrous fumarate over the past 10 years broken down by severity.
It is important to note that the search conducted included all ferrous fumarate containing products. Any ADR reports in which the form of the ferrous fumarate containing product was specified as oral solution, oral suspension or syrup have been excluded from the table below.
Whilst we encourage reporters to provide as much detail as possible about the medicine, the form of the drug is not a mandatory field on the Yellow Card and may not always be reported. Therefore, the number of reports provided below may not be a true reflection of the number of Yellow Card reports submitted for ferrous fumarate tablets.
Table 1: All direct UK spontaneous suspected ADR reports received between 1st January 2012 up to and including 3rd October 2022 in association with all ferrous fumarate containing products, broken-down by the year and severity. Any ADR reports in which the form of the ferrous fumarate containing product was specified as oral solution, oral suspension or syrup have been excluded.
| Number of ADR reports | |||
|---|---|---|---|
| Year | Fatal | Serious | Non-serious |
| 2012 | 0 | 1 | 0 |
| 2013 | 0 | 5 | 5 |
| 2014 | 0 | 9 | 4 |
| 2015 | 0 | 5 | 11 |
| 2016 | 0 | 11 | 13 |
| 2017 | 0 | 14 | 7 |
| 2018 | 0 | 22 | 12 |
| 2019 | 1 | 16 | 19 |
| 2020 | 0 | 12 | 16 |
| 2021 | 0 | 24 | 14 |
| 2022 | 0 | 11 | 15 |
Please also find attached a Drug Analysis Print (DAP) for the 246 UK spontaneous suspected ADR reports received directly by the MHRA associated with ferrous fumarate over the past 10 years. Any ADR reports in which the form of the ferrous fumarate containing product was specified as oral solution, oral suspension or syrup have been excluded. The DAP contains complete data for all spontaneous side effects reported within these ADR reports, reported via the Yellow Card scheme from healthcare professionals and members of the public.
When considering the data provided within this response, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the medicine or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different medicines or vaccines. 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. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.
Finally, regarding your request of the number of prescriptions that were issued per year in last 10 years in UK, I would like to highlight that the MHRA does not hold this information, this is the remit of the UK Health Security Agency (UKHSA). Contact information for UKHSA can be found here: https://www.gov.uk/government/organisations/uk-health-security-agency.
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
Safety and Surveillance
Medicines and Healthcare products Regulatory Agency