FOI release

Freedom of Information request (FOI 22/979)

Published 17 January 2024

FOI 22/979

20th October 2022

Dear

Thank you for your email dated 21st September 2022, where you asked for information on the following:

1. Please can you provide any information you have on the interaction between alcohol and Citalopram, including adverse, or non-adverse events when the two have been taken together.

2. Please can you provide any correspondence and information relating to the statement “you can drink alcohol while taking Citalopram” which is made on the NHS website.

Further to your request I can confirm up to and including 30/09/2022 that the MHRA has received 13 UK spontaneous suspected ADR reports associated with citalopram and alcohol interaction. Please note that under the FOI act, we can only release FOI Category 1b data on these cases which includes the following:

• Aggregated patient age

• Aggregated patient gender (number of males and females)

• Suspect drug(s)

• Dose of suspect drug

• Route of administration Duration of treatment

• Suspected adverse drug reaction(s)

• Outcome of reaction

• Reaction onset times

• Patient medical history

• Year of receipt

Please find attached the available details of these ADRreports in table 1, 2 and 3.

When reviewing spontaneous ADR data, it is important to also bear in mind the following points:

• A report of a suspected ADR report does not necessarily mean that a medicine has caused the event, just that there is a suspicion that it could have been responsible. Many factors have to be taken into account in assessing causal relationships including temporal association and any underlying or undiagnosed illness.

• The number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as this scheme is associated with an unknown and variable level of under-reporting - i.e. not all reports of suspected ADRs are reported as it is not mandatory for healthcare professionals to report suspected ADRs to the MHRA.

• ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use of a particular drug and promotion and publicity about a drug.

With regards to question 2, I can confirm that the MHRA has no input into the content published on the NHS website. The statement on the NHS website reflect that no studies demonstrated pharmacodynamic or pharmacokinetic interactions between citalopram and alcohol. It is important to note that whilst it is possible to consume alcohol during treatment with citalopram it is not recommended. The product information for citalopram which is provided to all patients starting treatment states the following regarding concurrent alcohol use “As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although citalopram has not been shown to increase the effects of alcohol”. The full product information can be reviewed at https://www.medicines.org.uk/emc/product/992/smpc.

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