Swissmedic Vigilance News Edition 21 – November 2018

Drug safety and signals
Medical monitoring of psychiatric
disorders in patients taking oral
isotretinoin for severe acne – Update
Introduction
During the clinical development of a drug,
only the most common adverse reactions
which are primarily attributable to the pharmacological
mechanism can be identified.
Once a drug is launched on the market, the
patients receiving the drug become more
numerous and heterogeneous, potentially
altering the safety profile of the drug.
Therefore, side effects of medicines observed
in daily medical practice must be reported,
in accordance with the current Therapeutic
Products Act, so that safety data,
which are still inevitably incomplete when
the medicines are launched on the market,
can be collated by Swissmedic.
The following patient history was taken
from an adverse drug event report forwarded
to Swissmedic by a regional pharmacovigilance
centre. The aim of this article is
to use this specific example to illustrate the
potential risk of the onset of psychiatric side
effects during oral treatment with isotretinoin.
Completed with due care and attention, this
article is intended to alert healthcare professionals
to the problem and provide them
with useful information for patients suffering
from severe acne and for whom oral
treatment with isotretinoin is indicated.
Case narrative
The report concerns a 15-year-old male adolescent
with a severe form of acne that failed
to respond to standard therapeutic cycles,
including systemic antibiotics and topical
treatment. Treatment with oral isotretinoin
was started in April 2016. The patient was
not taking any other medication. Three
weeks after starting the treatment, in May
2016, the patient attempted to commit suicide
with his mother's painkillers, specifically
ibuprofen tablets, although the total ingested
dose is not known. He was admitted
to the emergency department the same day
and remained clinically stable. The laboratory
test results showed no abnormalities.
He was transferred to a psychiatric hospital
a few days later. Although it was difficult to
obtain a history from the patient because he
was very withdrawn, he did not describe any
previous psychiatric problems. Nor did the
history taken from his parents reveal any relevant
issues. The treatment with isotretinoin
was discontinued in this young patient following
his suicide attempt. The adolescent,
who remained in hospital for several weeks,
showed a slight improvement in mood, with
the disappearance of suicidal thoughts, following
the introduction, according to the
history, of a quetiapine-based antidepressant
in the form of tablets.
Discussion
Acne is a disabling facial skin disorder, particularly
in its severe form that can have significant
social and psychological consequences
and also interfere with the activities
of daily living.
The term "depression" covers a large and
wide variety of possible meanings. The nuances
range from sadness to despair, via inertia,
lack of energy, with the possibility of
black thoughts and even suicide.
Isotretinoin, the treatment of choice for severe
cases of acne, is a systemic retinoid.
Although abundant medical literature is
available on the subject of psychiatric disorders,
the onset of depression and mood disorders,
the causality of oral isotretinoin is
still a matter of debate, particularly since
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