Freedom of Information request (FOI 22/1093)
Published 17 January 2024
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2nd December 2022
FOI 22/1093
Dear
Thank you for your email dated 4th November 2022, where you requested information on;
• Another way to view information for Pregabalin (Lyrica) and dihydrocodeine.
Firstly, apologies that you were not able to easily view the information provided in the graphs via the Yellow Card App, your feedback has been noted and will be addressed in future accessibility improvements. We are currently in the process of enhancing our systems and a new method to access data will initially be rolled out to the Yellow Card website, before implementation back into the mobile app; these systems will be tested to ensure they meet accessibility requirements.
You may be aware that we already host ADR data on the Yellow Card website for medicines in the form of interactive Drug Analysis Profiles https://yellowcard.mhra.gov.uk/idaps. However, in case you are also unable to access these reports I have provided further information below. I can confirm up to and including 30/11/2022 we have now received a total of 1512 UK spontaneous Adverse Drug Reaction (ADR) reports for dihydrocodeine and 2001 ADR reports specifically reporting the product name Lyrica. As Lyrica is a brand name for the active ingredient, pregabalin, you may be interested to know we have also received 4100 ADR reports for pregabalin. This includes all reports either where pregabalin has been reported or where a particular brand has been reported which contains pregabalin.
Please find attached Drug Analysis Prints (DAP) for pregabalin, Lyrica and dihydrocodeine up to and including 30/11/2022. Please note, as it is possible for one report to contain multiple ADRs, the number of ADRs is greater than the number of individual cases. Please also find attached a DAP guidance sheet which provides you with further information on how to interpret the print.
When considering the data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a 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 vaccines. 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.
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