Baroness Merron, the Department of Health and Social Care, has provided the following answer to your written parliamentary question (HL4198):
Question:
To ask His Majesty’s Government how many “yellow card” reports the Medicines and Healthcare products Regulatory Agency received for each antidepressant in 2024. (HL4198)
Tabled on: 20 January 2025
Answer:
Baroness Merron:
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses the available data, including from the Yellow Card scheme, and seeks advice from the Commission on Human Medicines, the MHRA’s independent advisory committee, where appropriate, to inform regulatory decisions, including amending the product information.
The MHRA has received a total of 2,911 reports through the Yellow Card scheme for all antidepressant medications between 1 January 2024 and 31 December 2024. The following table shows the number of United Kingdom Yellow Card reports received for adverse reactions, suspected to be associated with antidepressants, in 2024:
| Drug substance | Total number of reports |
| Agomelatine | 9 |
| Amitriptyline | 337 |
| Citalopram | 267 |
| Clomipramine | 3 |
| Dosulepin | 2 |
| Doxepin | 3 |
| Duloxetine | 270 |
| Escitalopram | 160 |
| Fluoxetine | 246 |
| Fluvoxamine | 5 |
| Imipramine | 5 |
| Lofepramine | 6 |
| Mianserin | 2 |
| Mirtazapine | 333 |
| Nortriptyline | 34 |
| Paroxetine | 46 |
| Phenelzine | 3 |
| Sertraline | 868 |
| Tranylcypromine | 1 |
| Trazodone | 38 |
| Tryptophan | 40 |
| Venlafaxine | 240 |
| Vortioxetine | 69 |
It is important to note that the inclusion of a particular report on the MHRA’s Yellow Card system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, 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 known. Some antidepressants are licensed for several different mental health conditions and may be recommended before other treatments in clinical guidance. It is therefore important not to compare numbers of reports for each antidepressant, as usage will differ.
Date and time of answer: 29 Jan 2025 at 13:07.
