Here is the reply from the MHRA. Merck don’t even need to hire a lawyer - the drug regulators are doing all their work for them!
Thank you for your email regarding the safety profile of finasteride 1mg for the use of male pattern
baldness.
You note that there have been another two reported deaths within the past year following the use of
finasteride. We currently have very few details regarding these cases. However; we are in the process
of following up these cases with the relevant reporters and health care professionals for information that
will help us to better evaluate the relationship with finasteride. As you may be aware, the risk of suicide
is increased in men of this age, according to the Office of National Statistics (ONS)
ons.gov.uk/peoplepopulation … etins/suic
idesintheunitedkingdom/2014registrations
In December 2015, Health Canada conducted a review which concluded that at present there is not
enough evidence to attribute suicidal ideation to finasteride use. More details of this review can be
found at this link:
hc-sc.gc.ca/dhp-mps/medeff/b … 12-eng.php
Within Europe at the Pharmacovigilance Risk Assessment Committee, the EU is conducting our own
review of depression and related terms including suicidality. The results of this review will be available
later in the year.
As in previous correspondence, we would like to stress that patient safety is extremely important to us
and can assure you that we are continuing to monitor the risk-benefit for finasteride for male pattern
baldness.
Specific issues that we are monitoring include those around sexual dysfunction, which you have
previously reported. As well as this, all safety information relating to the use of finasteride in Europe is
reviewed in regular periodic safety update reports. This includes reviewing all adverse events reported
in the EU together with all relevant published literature and research (including information provided by
the Post Finasteride Syndrome Foundation).
We would like to thank you for contacting us and for the further follow information you have provided on
your experiences. If you have any further details regarding your own case that you think could be
useful, especially in regard to a medical endocrinology review, we would welcome this information. Any
new information should be quoted in relation to reference number ADR 22287889.
Yours faithfully
Alie Banner Simpson
Scientific Assessor
Benefit & Risk Management Group (Unit 1)
Medicines and Healthcare Regulatory Products Agency
Floor 3-O
151 Buckingham Palace Road
London
SW1W 9SZ