FOI release

Freedom of Information request on the list of side effect options on the yellow card reporting scheme (FOI 21/1042)

Published 27 April 2022

11th October 2021

FOI 21/1042

Dear

Thank you for your email dated 13th September 2021, where you requested the following under the Freedom of Information Act:

“In the list below, I have selected 14 different side effects that can be reported to you as a side effect of medication under the Yellow Card scheme. For each of the side effects please state how many reports you received of that side-effect across all medications/drugs in the 5-year period from the 1st January 2016 to the 31st December 2020. Then for each side effect state the two drugs that recorded the most side effects, stating the name of the drug and the number of reports it was responsible for.”

As per your request, please find below a breakdown of the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports received by the MHRA for the requested reaction terms between 01/01/2016 and 31/12/2020 and the most commonly reported suspect drugs in these reports (data extracted 04/10/2021).

Table 1: A breakdown of the total number of UK spontaneous suspected ADR reports for different preferred terms (PT), and the top two suspect drugs reported for cases received from 1st January 2016 to 31st December 2020

Reported reaction (preferred term)	Total number of ADR reports	Top reported drug & no. of ADR reports	Second most reported drug & no. of ADR reports
Flatulence	653	Omeprazole - 33	Human rotavirus and rotavirus - 32
Excessive sexual fantasies	0	N/A	N/A
Loss of libido	287	Sertraline - 32	Finasteride, and isotretinoin - 29 each
Hypersexuality	29	Aripiprazole - 7	Ropinirole - 6
Libido increased	30	Aripiprazole - 6	Clozapine, quetiapine, and sertraline - 3 each
Gambling disorder	41	Aripiprazole -21	Pramipexole - 9
Compulsive shopping	7	Ropinirole - 3	Aripiprazole, pramipexole - 2 each
Transvestism	0	N/A	N/A
Voyeurism	0	N/A	N/A
Obsessive-compulsive disorder	72	Isotretinoin - 11	Montelukast - 9
Yawning	75	Sertraline - 22	Citalopram - 12
Cyanopsia	3	Sildenafil, hydroxychloroquine, arginine and avena sativa and eleutherococcus, senticosus and lepidium mevenii and magnesium citrate and magnesium stearate and resveratol and serenoa repens and vitamin B substances and zinc - 1 each
Priapism	60	Trazodone - 7	Risperidone - 6 Finasteride
Gynaecomastia	175	Spironolactone -24

When classifying Yellow Card data, all reactions that are reported to be experienced are classified using MedDRA, the Medical Dictionary for Regulatory Activities. As you may be already aware, this dictionary has a hierarchical mapping structure that allows for the grouping of medical terms and their lexical variants (LLTs) into larger more generalised medical concepts (HGLTs), and for these general medical concepts to be categorised into overarching system organ classes (SOCs). We have used the Preferred Term (PT) level of MedDRA to provide appropriate data for the requested reactions.

I can confirm that the MHRA has not received any spontaneous suspected UK ADR report that reports the MedDRA term ‘Excessive sexual fantasies’, ‘Transvestism’ or ‘Voyeurism’ as a suspect reaction in the time period requested.

From Table 1, it can be seen that for some side effect terms, more than one suspect drug can be reported in an ADR report so the sum of the reports for the 1st/2nd most reported drugs may be more than the total number of reports for that reaction.

As you may be aware, information about all licensed medicines including the recognised side effects is included in the product information provided for health professionals (the Summary of Product Characteristics or SPC) and in the information provided for patients (the Patient Information Leaflet or PIL). You may also view electronic versions of the product information from the electronic medicines compendium website at https://products.mhra.gov.uk/.

Furthermore, it is also important to note that a report of a reaction does not necessarily mean that it has been caused by the drug in question. We encourage reporters to report suspected ADRs i.e. the reporter does not have to be sure of a causal association between the drug and the reactions – a mere suspicion will suffice. Therefore, reports submitted to MHRA may be true side-effects or they may be due to concurrent diagnosed or undiagnosed illness, other concomitant medicines (those medications taken at the time of, or up to three months prior to the onset of reactions), or they may be purely co-incidental events that would have occurred anyway in the absence of therapy. It is also important to note that some reports have listed multiple medications that are considered as ‘suspect’ in relation to the onset of the reaction; as such, causality can be more difficult to assess.

It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division