Freedom of Information request on the yellow card reports for Imiquimod [of] skin discolouration, skin depigmentation, skin hypopigmentation and vitiligo (FOI 22/489)
Published 31 May 2022
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FOI 22/489
2nd March 2022
Dear
Thank you for your FOI request dated 23rd February 2022 in which you requested to see “detailed yellow card reports for Imiquimod [of] skin discolouration, skin depigmentation, skin hypopigmentation and vitiligo”.
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 Imiquimod can be accessed here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000538603751.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. 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.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division