Sexual Dysfunction: Prescription Drugs
(asked on 16th April 2024) - View Source
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many prescriptions for amitriptyline, imipramine and atomoxetine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA has received for each of these drugs in each year since 2014; and whether they will ensure that persistent sexual dysfunction is listed as a side effect in the patient information leaflets for each these drugs.
Over the next year, the Medicines and Healthcare products Regulatory Agency (MHRA) plans to review the risk of sexual dysfunction and whether these side effects persist for all antidepressants marketed in the United Kingdom. As a result of the review product information will be updated, as necessary, and consideration will be given to whether additional risk minimisation measures are needed.
The following table shows the total number of items in each calendar year between 2014 and 2023, as well as January 2024:
Calendar Year | Amitriptyline Hydrochloride | Atomoxetine Hydrochloride | Imipramine Hydrochloride |
2014 | 11,851,704 | 118,843 | 174,731 |
2015 | 12,404,537 | 125,680 | 167,072 |
2016 | 12,943,138 | 130,731 | 164,645 |
2017 | 13,256,893 | 134,785 | 156,555 |
2018 | 13,532,567 | 138,160 | 150,526 |
2019 | 13,975,389 | 141,907 | 151,889 |
2020 | 14,468,134 | 146,346 | 137,284 |
2021 | 14,930,177 | 158,339 | 123,450 |
2022 | 15,226,816 | 174,894 | 115,360 |
2023 | 15,662,619 | 178,150 | 108,197 |
January 2024 | 1,370,670 | 15,334 | 9,072 |
Data Source: NHS Business Services Authority Open Data Portal, PCA data
The MHRA has received a total of 38 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with amitriptyline, atomoxetine, and imipramine. Of these, 8 were for amitriptyline, 21 for atomoxetine, and 2 for imipramine.
‘Persistent sexual dysfunction’ does not represent a specific medical condition.
The following table shows a summary of these side effects listed in the product information:
| Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) | Rare (may affect up to 1 in 1,000 people) |
amitriptyline | erectile dysfunction, libido decreased |
|
|
imipramine | disturbances of libido, impotency or abnormal ejaculation |
|
|
atomoxetine | libido decreased, ejaculation disorder, erectile dysfunction, male genital pain | Ejaculation failure | Priapism |