Freedom of Information request (FOI 22/938)
Published 17 January 2024
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FOI 22/938
28th September 2022
Dear
Thank you for your Freedom of Information request dated 31st August 2022, where you requested the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports of sexual dysfunction reactions associated a SSRI.
Further to your request for the number of UK spontaneous suspected ADR reports of sexual dysfunction reactions associated with a SSRI, I can confirm that up to and including the 7th September 2022 the MHRA has received a total of 1762 UK spontaneous suspected ADR reports of sexual dysfunction reactions associated with a SSRI. As requested, please see below a breakdown of the number of reports which fall into the following categories:
UNKNOWN whether the reaction continued after drug withdrawn: 1135
Reaction did NOT continue after drug withdrawn: 232
Reaction continued after drug withdrawn and the recovery time is unknown: 245
Reaction continued after drug withdrawn and the recovery time is known: 144
It is important to note that cases included in the category ‘Unknown whether the reaction continued after drug withdrawn’ will also include cases where the patient has continued treatment with the SSRI, or it is not known whether the SSRI has been withdrawn.
Furthermore, the ‘action taken with drug’ field denotes to what action was taken regarding the drug as a result of the side effect experienced e.g. the drug was withdrawn as a result of the reaction. Please also note that the ‘action taken with drug’ and reaction outcomes are not mandatory fields on the Yellow Card and therefore may not always be reported. Where these fields have not been reported, they default to unknown. Additionally, the reaction outcome reflects what is provided at the time of reporting however we do make every effort to follow-up with reporters for additional information including the outcome of any side effects. Despite this we may not always receive this information.
In terms of your questions, I can confirm:
Of these 1762 ADR reports, 389 reports (245 + 144) indicate that the sexual dysfunction persisted after discontinuation of the drug.
In can confirm that 501 of these 1762 suspected ADR reports of sexual dysfunction associated with SSRIs were received directly from members of the public (patients, parents or their carers) and all of these contained contact details (either a postal address or email address). Therefore, all these reports should have received an acknowledgment either via the post if a paper form was submitted to us, or electronically if they submitted their report via our Yellow Card website (providing they supplied an email address with the report).
With regards to the number of reports followed up for further information with regards to the outcome of their reaction, I can confirm that for the category ‘Unknown whether the reaction continued after drug withdrawn’ 186 cases have been followed up within this category. For the category ‘Reaction continued after drug withdrawn and the recovery time is unknown’ 95 cases have been followed-up.
If further information is received as a result of our request, the case is updated on our database and reassessed via our routine signal detection processes. Any change in category is reflected in the above breakdown.
As stated in previous correspondence; not all ADR reports received by the MHRA are suitable for follow-up due to a number of different reasons.
It is important to note that Yellow Card reports are not proof of a side effect occurring due to the medicine but only a suspicion by the reporter that the medicine may have caused the side effect. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of the medicine. When interpreting these data, it is important to note that the number of reports received should not be used as a basis for determining the incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the drug is included in this data.
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.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division