Freedom of Information request on suspected adverse sexual effect caused by Prozac (FOI 21-390 and FOI 21-391)
Published 28 June 2021
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Thank you for both your emails dated 10 th April 2021, where you requested:
• The date on which the MHRA were first informed of any suspected adverse sexual effect caused by Prozac which persisted after the drug was discontinued. I am also requesting the date on which the MHRA reported this information to the manufacturer Eli Lilly. • The name of the antidepressant drug which was the first antidepressant reported to the MHRA as being suspected of causing sexual dysfunction which persisted after the drug was discontinued. I have previously been informed by MHRA that this first report was made in 1987.
When looking at reports we have received of any suspected adverse sexual effect caused by the brand Prozac, we looked at all cases where a reaction term reported was in any of the below categories as per our medical dictionary (MedDRA)1 : • Sexual and gender identity disorders NEC (Not Elsewhere classified) • Sexual arousal disorders • Sexual desire disorders • Sexual dysfunction NEC (Not Elsewhere classified) • Sexual function and fertility disorders NEC (Not Elsewhere classified) • Sexuality issues
I can confirm the first Yellow Card report in association with Prozac reporting a reaction in any of the above mentioned categories, which was reported as not recovered after Prozac was discontinued was received on, 19/12/1991. 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. There is a legal obligation to process serious ADR reports onto our database within 15 days. Once a report is received and entered onto our database the marketing authorisation holder of the suspect drug within the report, 1 MedDRA, is the internationally agreed list of terms used for Medicines Regulation. MedDRA groups related adverse drug reaction terms in a hierarchical structure: https://www.meddra.org/about-meddra/visionreceives an anonymised copy of the report. Therefore, I can confirm that Eli Lilly, the MAH for Prozac, received this report in January 1982. Further to your second request, I can confirm that Seroxat is the name of the first antidepressant medication reported to the MHRA as being suspected of causing a ‘sexual dysfunction’ which persisted after the medication was discontinued; this was reported as you correctly state in 1987. 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