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<p>The following table shows the total number of items issued for mirtazapine, each
year since 2014 to 2023:</p><table><tbody><tr><td><p>Time Period</p></td><td><p>Total
items issued</p></td></tr><tr><td><p>2014</p></td><td><p>6,056,918</p></td></tr><tr><td><p>2015</p></td><td><p>6,783,906</p></td></tr><tr><td><p>2016</p></td><td><p>7,526,200</p></td></tr><tr><td><p>2017</p></td><td><p>8,198,345</p></td></tr><tr><td><p>2018</p></td><td><p>8,938,362</p></td></tr><tr><td><p>2019</p></td><td><p>9,702,599</p></td></tr><tr><td><p>2020</p></td><td><p>10,532,577</p></td></tr><tr><td><p>2021</p></td><td><p>11,249,963</p></td></tr><tr><td><p>2022</p></td><td><p>11,776,025</p></td></tr><tr><td><p>2023</p></td><td><p>12,401,593</p></td></tr></tbody></table><p>Source:
Data was provided by the NHS Business Services Authority, using the British National
Formulary chemical substance mirtazapine</p><p>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 available data, including from the Yellow Card
scheme, and seeks advice from their independent advisory committee, the Commission
on Human Medicines, where appropriate to inform regulatory decisions.</p><p>The MHRA
has received a total of 46 Yellow Card reports of sexual dysfunction related reactions
suspected to be associated with mirtazapine, four of which include information that
suggest the suspected adverse reactions persisted after mirtazapine was withdrawn.
The following table shows the number of Yellow Card reports of suspected mirtazapine
related sexual dysfunction, and reports of sexual dysfunction that persisted after
the drug was withdrawn, each year from 2014 to 2024:</p><table><tbody><tr><td><p>Year</p></td><td><p>Reports
of sexual dysfunction</p></td><td><p>Reports of sexual dysfunction that continued
after mirtazapine was withdrawn</p></td></tr><tr><td><p>2014</p></td><td><p>3</p></td><td><p>0</p></td></tr><tr><td><p>2015</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2016</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2017</p></td><td><p>3</p></td><td><p>0</p></td></tr><tr><td><p>2018</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2019</p></td><td><p>5</p></td><td><p>1</p></td></tr><tr><td><p>2020</p></td><td><p>3</p></td><td><p>0</p></td></tr><tr><td><p>2021</p></td><td><p>5</p></td><td><p>1</p></td></tr><tr><td><p>2022</p></td><td><p>10</p></td><td><p>1</p></td></tr><tr><td><p>2023</p></td><td><p>9</p></td><td><p>0</p></td></tr><tr><td><p>2024</p></td><td><p>4</p></td><td><p>1</p></td></tr></tbody></table><p>Source:
data provided by the MHRA.</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 MHRA continuously monitors the safety of medicines on the United
Kingdom’s market, including mirtazapine. Reports of suspected adverse reactions are
reviewed weekly by a multidisciplinary team as part of the MHRA’s signal detection
process. The term signal is used to define any suspected adverse reaction or potential
safety concern that requires further evaluation.</p><p>Responsibility for adding a
side effect to the product information leaflet sits with the MHRA. The product information
for mirtazapine reflects the data currently available, and does not include sexual
dysfunction as a possible side effect. However, data from Yellow Card reports and
other sources such as published studies and periodic safety assessments are kept under
continuous review by the MHRA. The marketing authorisation holder has recently submitted
the latest periodic safety update report to the MHRA, and this will be carefully assessed.
If there is sufficient evidence and associated data about the potential to experience
sexual dysfunction as a side effect, the patient information for mirtazapine can be
updated.</p>
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