Baroness Merron, the Department of Health and Social Care, has provided the following answer to your written parliamentary question (HL401):
Question by Lord Alton of Liverpool:
To ask His Majesty’s Government how many prescriptions for trazodone have been issued in each year since 2014; how many ‘Yellow Card’ reports of sexual dysfunction and persistent sexual dysfunction in respect of trazodone the MHRA has received each year since 2014; and what consideration NHS England has given to adding sexual dysfunction as a side effect on the patient information leaflets for trazodone. (HL401)
Tabled on: 29 July 2024
Answer:
Baroness Merron:
The following table shows the total number of items issued for trazodone from 2014 to 2023, and from January to May 2024:
| Year | Total number of items |
| 2014 | 1,050,069 |
| 2015 | 1,083,974 |
| 2016 | 1,112,437 |
| 2017 | 1,133,363 |
| 2018 | 1,157,717 |
| 2019 | 1,168,715 |
| 2020 | 1,191,060 |
| 2021 | 1,226,973 |
| 2022 | 1,238,983 |
| 2023 | 1,281,049 |
| 2024 | 553,866 |
Source: data was provided by the NHS Business Service Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance trazodone hydrochloride.
Note: items have been dispensed, but not necessarily prescribed, in England.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring 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 where appropriate it seeks advice from its independent advisory committee, the Commission on Human Medicines, to inform on regulatory decisions, including the amending of product information.
The MHRA has received a total of 20 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with trazodone, between 1 January 2014 and 29 July 2024. This includes reactions grouped under the medical dictionary’s (MedDRA) Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction, and include erection and ejaculation conditions and disorders, orgasmic disorders and disturbances, sexual arousal disorders, and others. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with trazodone in the United Kingdom, received by the MHRA each year from 2014 to 2024:
| Year | Reports of sexual dysfunction |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 1 |
Source: data provided by the MHRA.
“Persistent sexual dysfunction” does not represent a specific medical condition, so this precise term is not a category available for a structured search of the MHRA’s Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.
It is important to note that the inclusion of a particular report on the MHRA’s 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.
The product information for trazodone, which includes the patient information leaflet, reflects the data currently available, and does not include sexual dysfunction as a possible side effect but does include priapism, the prolonged erection of the penis. The Summary of Product Characteristics for healthcare professionals states that there have been reports of priapism which have required surgical intervention, or led to permanent sexual dysfunction. Patients developing priapism should stop using trazodone immediately.
Date and time of answer: 06 Aug 2024 at 16:04.
