FOI release

Freedom of Information request on adverse sexual dysfunction reactions to SSRI use (FOI 21-232)

Published 28 May 2021

8th April 2021 FOI 21/232 Dear

Thank you for your Freedom of Information request dated 6th March 2021.

Further to your request for the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports of sexual dysfunction reactions associated with SSRI use; I can confirm that up to the 17th March 2021 the MHRA has received a total of 1654 UK spontaneous suspected ADR reports of sexual dysfunction associated with SSRIs. The breakdown of these reports is as follows:

UNKNOWN whether the reaction continued after drug withdrawn: 1069 Reaction did NOT continue after drug withdrawn: 225 Reaction continued after drug withdrawn and the recovery time is unknown: 216 Reaction continued after drug withdrawn and the recovery time is known: 144

It is important to note that cases included in the category ‘Unknown whether the reaction continued after drug withdrawn’ will also include cases where the patient has continued treatment with the SSRI, or it is not known whether the SSRI has been withdrawn. It is not mandatory to provide the outcome of the suspected ADR or to provide the action taken with the suspect drug as a result of the suspected ADR when submitting a Yellow Card report to the MHRA.

Of these 1654 cases, 360 (216 + 144) indicate that the sexual dysfunction persisted after discontinuation of the drug.

I can confirm that 456 of these 1654 suspected ADR reports of sexual dysfunction associated with SSRIs were received directly from members of the public (patients or their carers) and all of these contained contact details (either a postal address or email address). 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the outcome of their reaction, I can confirm that for the category ‘Unknown whether the reaction continued after drug withdrawn’ 186 cases have been followed up within this category. For the category ‘Reaction continued after drug withdrawn and the recovery time is unknown’ 95 cases have been followed-up.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, 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