Freedom of Information request on information on Primodos via the Yellow Card Scheme in 1975 (FOI 21/919)
Published 20 January 2022
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25th August 2021
FOI 21/919
Dear
Thank you for your email dated 12th August 2021, where you asked for information on all information recorded via the Yellow Card scheme for the drug Primodos specifically for 1975.
As per your request, please find attached a Product Analysis Print (PAP) Primodos. The print contains information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up until the 15/08/2021. Please also find attached a PAP guidance sheet which provides you with further information on how to interpret the print.
Please note, there is one cases where the date was reported as 1975 . As date of administration is not a mandatory field, this may not be a true reflection of all cases from 1975. Furthermore, reporters are able to submit at any time and possible reports received after 1975 may not indicate the dates for when the drug was administered.
It is important to note that the inclusion of a particular reported reaction in the PAP does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. We encourage such reporting to ensure we can continually appraise the safety of vaccines and medicines. The fact that symptoms occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the vaccine. 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, 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.
As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: MHRA Products - Home for details on the possible side effects of each medicine.
I hope the information provided is helpful, but 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