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<p>The following table shows the total number of items issued for trazodone from 2014
to 2023, and from January to May 2024:</p><table><tbody><tr><td><p>Year</p></td><td><p>Total
number of items</p></td></tr><tr><td><p>2014</p></td><td><p>1,050,069</p></td></tr><tr><td><p>2015</p></td><td><p>1,083,974</p></td></tr><tr><td><p>2016</p></td><td><p>1,112,437</p></td></tr><tr><td><p>2017</p></td><td><p>1,133,363</p></td></tr><tr><td><p>2018</p></td><td><p>1,157,717</p></td></tr><tr><td><p>2019</p></td><td><p>1,168,715</p></td></tr><tr><td><p>2020</p></td><td><p>1,191,060</p></td></tr><tr><td><p>2021</p></td><td><p>1,226,973</p></td></tr><tr><td><p>2022</p></td><td><p>1,238,983</p></td></tr><tr><td><p>2023</p></td><td><p>1,281,049</p></td></tr><tr><td><p>2024</p></td><td><p>553,866</p></td></tr></tbody></table><p>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. <br> Note: items have been dispensed,
but not necessarily prescribed, in England.</p><p>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.</p><p>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:</p><table><tbody><tr><td><p>Year</p></td><td><p>Reports of sexual
dysfunction</p></td></tr><tr><td><p>2014</p></td><td><p>1</p></td></tr><tr><td><p>2015</p></td><td><p>2</p></td></tr><tr><td><p>2016</p></td><td><p>2</p></td></tr><tr><td><p>2017</p></td><td><p>1</p></td></tr><tr><td><p>2018</p></td><td><p>1</p></td></tr><tr><td><p>2019</p></td><td><p>2</p></td></tr><tr><td><p>2020</p></td><td><p>2</p></td></tr><tr><td><p>2021</p></td><td><p>1</p></td></tr><tr><td><p>2022</p></td><td><p>5</p></td></tr><tr><td><p>2023</p></td><td><p>2</p></td></tr><tr><td><p>2024</p></td><td><p>1</p></td></tr></tbody></table><p>Source:
data provided by the MHRA.</p><p>“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 <em>The Diagnostic and Statistical
Manual of Mental Disorders Fifth Edition</em>, or the <em>International Classification
of Diseases 11th Revision</em>. A search of the database would therefore rely on manual
assessment of individual cases.</p><p>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.</p><p>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.</p>
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