Freedom of Information request (FOI 22/873)
Published 17 January 2024
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FOI 22/873
11th August 2022
Dear
Thank you for your FOI request dated 5th August 2022 in which you asked ‘Has there been an increase in Yellow Cards regarding possible adverse reactions to Mexiletine since February?’
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 mexiletine can be accessed here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000247933536.zip&agency=MHRA. This shows that we have received two Yellow Card reports for mexiletine so far this year; one non-serious, and one serious (non-fatal).
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