FOI release

Freedom of Information request on Yellow Card reports of tinnitus received for venlafaxine (FOI 21-245)

Published 28 June 2021

Thank you for your Freedom of Information request dated 16 th April 2021, in which you requested details of the outcomes of the Yellow Card reports of tinnitus received for venlafaxine.

As stated in your email, as of the 28th February 2021, the MHRA have received 104 UK spontaneous suspected adverse reaction (ADR) reports of venlafaxine in association with tinnitus. A breakdown of the above-requested information is provided in the table below.

Table 1. Total number of UK spontaneous suspected ADR reports of tinnitus associated with venlafaxine, by reaction outcome. Tinnitus reaction outcome Number of reports Not recovered/not resolved 46 Recovered/resolved 29 Recovered/resolved with sequelae 1 Recovering/resolving 14 Unknown 14 Total 104

Please note that the outcomes displayed above are reflective of those being provided at the time of reporting to us.

With regards to your second request for detail on the action taken with the drug and the subsequent outcome of the reaction. The MHRA are committed to sharing Yellow Card data with the general public, however we are also committed to maintaining patient and reporter confidentiality. As such, there are various types of Yellow Card data that the MHRA can release. Category Ia data consists of anonymised aggregated ADR data in the format of interactive Drug Analysis Profiles (iDAPs). These contain complete listings of all suspected adverse drug reactions or side effects, which have been reported to the MHRA via the Yellow Card Scheme. These are freely available from our website at https://yellowcard.mhra.gov.uk/iDAP/. Category Ib concerns a list of data fields which exclude any information that can identify the patient and reporter and therefore can be released without the need for consideration from the Pharmacovigilance Expert Advisory Group (PEAG) under the FOI act. Unfortunately, information surrounding the action taken with drug is not releasable under a 1b data request. Furthermore, it should be noted that provision of this information by reporters is not obligatory when submitting a Yellow Card, and therefore it may not provide an accurate representation of what is occurring in the clinical setting.

When assessing the data provided above and on the iDAPs, it is important to note that even though tinnitus is a recognised effect of venlafaxine, the inclusion of a report on our database does not necessarily mean that the events described were caused by the drug, only that the reporter had a suspicion it may have. Not all events have been medically confirmed or diagnosed as we encourage patients as well as healthcare professionals to report on the basis of suspicion alone. Furthermore, the number of reports received should not be used as a basis for determining incidence of a reaction as neither the total number of reactions occurring, nor the number of patients receiving the drug is included in this data. As such, please see the following link for the Summary of medicinal Product Characteristics (SmPC) which documents the recognised side effects of venlafaxine, with their associated frequencies: https://products.mhra.gov.uk/.

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