I attach below a copy of an email from the medicine regulatory body in the UK - the Medicines and Healthcare products Regulatory Agency (MHRA) who are responsible for licencing drugs, issuing warning and guiding physicians and patients to side effects.
They are pursuing a review of the safety of finasteride, with a focus on cognitive and affective symptoms.
I am strongly advocating that they pursue a wide-ranging review of the safety of this drug given increasing published reports of side effects on and after taking the drug, that currently have an unknown incidence.
The below email indicates a start to this process but is rather weak in that it simply involves asking the drug company for information.
I am asking people in the UK to add their own complaints to the MHRA here : https://yellowcard.mhra.gov.uk/
Your voice counts as the 'concern' that MHRA refers to is based largely on only a few hundred complaints about this drug over the last few years. Another couple of dozen reports would be of considerable consequence in pushing the body to conduct a thorough review.
You may also send an email to Pharmacovigilanceservice@mhra.gsi.gov.uk in order to express your desire for a thorough review to be conducted.
Even if you are not certain that your symptoms are due to finasteride, if you have any suspicion you should report your side effects as the MHRA itself recommends:
Please complete a Yellow Card if you have a suspicion that a drug has caused an adverse reaction. Do not delay reporting, even if you are in doubt about causality.
This is a tangible way to ensure that we and other people who are considering using the drug have access to reliable information about the medication's side effects and may come to a well-informed decision about whether or not to use it.
(If you are not in the UK you should also do the same thing in your country.
US here: https://www.accessdata.fda.gov/scripts/medwatch/
Australia here: https://www.tga.gov.au/reporting-problems)
Email follows:
20[SIZE=-1][SUP]th[/SUP][/SIZE] November 2014
Our Ref: GENQ- -xxxxxxx
Yellow Card Reference Number: ADR xxxxxxxx
Re: - Request for safety review of finasteride
Dear Dr xxxxxxx,
Thank you for your email on 29[SIZE=-1][SUP]th[/SUP][/SIZE] October 2014 regarding finasteride and in particular for your very detailed Yellow Card report.
We share your concern and have raised the issue of cognitive effects within the European regulatory environment. We are currently waiting for a review from the company on this issue. Once this information arrives and has been assessed, we will be in a better position to determine what action may need to be taken. The strength of the evidence in support of an effect together with the indicated use of the drug, the age of those affected, the seriousness of cases and persistence of effect will be taken into consideration.
We will write to you again once we have the outcome of the review. In the meantime we would be grateful for any further updates from you on your experiences using the Yellow Card reference number ADR xxxxxxxx.
Kind regards
Alison Banner Simpson
Scientific Assessor
Benefit & Risk Management Group (Unit 1)
Medicines and Healthcare Regulatory products Agency
3rd Floor (Orange)
151 Buckingham Palace Road
Victoria, London,
SW1W 9SZ
cc. Dr J Woolley. Therapeutic Group Unit Manager
They are pursuing a review of the safety of finasteride, with a focus on cognitive and affective symptoms.
I am strongly advocating that they pursue a wide-ranging review of the safety of this drug given increasing published reports of side effects on and after taking the drug, that currently have an unknown incidence.
The below email indicates a start to this process but is rather weak in that it simply involves asking the drug company for information.
I am asking people in the UK to add their own complaints to the MHRA here : https://yellowcard.mhra.gov.uk/
Your voice counts as the 'concern' that MHRA refers to is based largely on only a few hundred complaints about this drug over the last few years. Another couple of dozen reports would be of considerable consequence in pushing the body to conduct a thorough review.
You may also send an email to Pharmacovigilanceservice@mhra.gsi.gov.uk in order to express your desire for a thorough review to be conducted.
Even if you are not certain that your symptoms are due to finasteride, if you have any suspicion you should report your side effects as the MHRA itself recommends:
Please complete a Yellow Card if you have a suspicion that a drug has caused an adverse reaction. Do not delay reporting, even if you are in doubt about causality.
This is a tangible way to ensure that we and other people who are considering using the drug have access to reliable information about the medication's side effects and may come to a well-informed decision about whether or not to use it.
(If you are not in the UK you should also do the same thing in your country.
US here: https://www.accessdata.fda.gov/scripts/medwatch/
Australia here: https://www.tga.gov.au/reporting-problems)
Email follows:
20[SIZE=-1][SUP]th[/SUP][/SIZE] November 2014
Our Ref: GENQ- -xxxxxxx
Yellow Card Reference Number: ADR xxxxxxxx
Re: - Request for safety review of finasteride
Dear Dr xxxxxxx,
Thank you for your email on 29[SIZE=-1][SUP]th[/SUP][/SIZE] October 2014 regarding finasteride and in particular for your very detailed Yellow Card report.
We share your concern and have raised the issue of cognitive effects within the European regulatory environment. We are currently waiting for a review from the company on this issue. Once this information arrives and has been assessed, we will be in a better position to determine what action may need to be taken. The strength of the evidence in support of an effect together with the indicated use of the drug, the age of those affected, the seriousness of cases and persistence of effect will be taken into consideration.
We will write to you again once we have the outcome of the review. In the meantime we would be grateful for any further updates from you on your experiences using the Yellow Card reference number ADR xxxxxxxx.
Kind regards
Alison Banner Simpson
Scientific Assessor
Benefit & Risk Management Group (Unit 1)
Medicines and Healthcare Regulatory products Agency
3rd Floor (Orange)
151 Buckingham Palace Road
Victoria, London,
SW1W 9SZ
cc. Dr J Woolley. Therapeutic Group Unit Manager
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