Freedom of Information request on the adverse drug reaction (ADR) reports with cannabidiol (FOI 22/496)
Published 1 June 2022
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FOI 22/496
March 24th 2022
Dear
Thank you for your Freedom of Information email dated 24 February 2022, where you requested the details of the adverse drug reaction (ADR) reports with cannabidiol.
In your email you referred to 168 ADR reports on the interactive drug analysis profile (iDAP) for cannabidiol and requested further details of these. Following a more recent data run, I can confirm that up to and including 21st March 2022 we have received 242 UK spontaneous suspected ADR reports in relation to the use of cannabidiol. Please find enclosed a line listing containing details of suspect drug, reaction and outcome, patient past medical history, the year the report was received by the MHRA, and dosage and route of administration for the cannabidiol product. There is also an aggregated table for the age and sex of the patient, which protects the patient identity.
When considering the provided spontaneous ADR data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
As this data does not represent a list of possible side effects from cannabidiol, please refer to section 4 of the product information for cannabidiol products for these, an example can be found here; https://www.medicines.org.uk/emc/files/pil.10781.pdf.