Freedom of Information request on the adverse reactions reported relating to Botulinum Toxin from 2018 (FOI 22/774)
Published 21 December 2023
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FOI 22/774
23rd June 2022
Dear
Thank you for your FOI request dated 17th June 2022 in which you requested to see “total number of yellow card reports received for Botulinum Toxin in the years 2018 to the most recent date available” and “a breakdown of the level of adverse reaction detailed by the reports“.
For suspected side effects being reported, the MHRA publishes this information in the form of interactive Drug Analysis Profiles (iDAPs), of which the one for Clostridium Botulinum can be accessed here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000687749747.zip&agency=MHRA.
There is an iDAP for each licensed medicine by drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that have been reported to the MHRA and you may filter by type of reaction, level of reaction and year of report. It is important to note that reported adverse reactions have not been proven to be related to the drug and should not be interpreted as a list of known side effects.
I hope the information provided is helpful; however, 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.
Please remember to quote the reference number above in any future communications.
Kind regards,
FOI Team
Safety and Surveillance Division