FIRST TREATMENT AGAINST
SEVERE THYROID EYE DISEASE
EMA has recommended granting
a marketing authorisation in the
European Union (EU) for Tepezza
(teprotumumab), for the treatment
of adults with moderate to severe
thyroid eye disease.

Thyroid eye disease (TED), also
known as Graves’ eye disease, is
a rare autoimmune disease that
triggers inflammation of muscles,
fat, and other tissues around and
behind the eyes.

This can cause the eyes to bulge
(or protrude), and other symptoms,
including puffy eyelids, eye redness
and irritation, eye pain, double
vision, and eyelid retraction (when
the upper and/or lower eyelids are
pulled back more than normal). In
severe cases, TED can cause vision
loss and facial disfigurement.

Treatment options for moderate-
to-severe TED are limited and
most patients are treated with
corticosteroids, with some patients
needing multiple reconstructive
surgeries. The active substance of Tepezza
is teprotumumab, a monoclonal
antibody (a type of protein)
designed to block the autoimmune
activation of orbital fibroblasts
(specialised cells in the eye
sockets), potentially inhibiting the
development and progression of
TED. HIGHLIGHTS FROM THE PHARMACOVIGILANCE RISK
ASSESSMENT COMMITTEE (PRAC) MAY MEETING
Following an EU-wide review of
available data on finasteride and
dutasteride medicines, EMA’s safety
committee (PRAC) has confirmed
suicidal ideation (suicidal thoughts)
as a side effect of finasteride 1mg
and 5mg tablets but concluded
that the benefits of finasteride and
dutasteride medicines continue to
outweigh their risks for all approved
uses. The frequency of the side effect
is unknown, meaning that it is not
possible to estimate it from available
data. A warning about mood changes,
including depression, depressed
mood and suicidal ideation, is
already included in the product
information for finasteride
medicines. Patients who experience mood
changes should seek medical advice
and, if taking finasteride 1 mg, should
also stop treatment.

Most cases of suicidal ideation
were reported in people using 1mg
finasteride to treat hair loss due to
male hormones.

The product information for
finasteride 1 mg will now also alert
patients about the need to seek
medical advice if they experience
problems with sexual function
(such as decreased sex drive or
erectile dysfunction) that have been
reported to contribute to mood
alterations and suicidal ideation in
some patients.

A patient card will be included
in the 1mg finasteride package
to remind patients of these risks
and to advise them about the
appropriate course of action.

Although a link between suicidal
18 CHP PACKER INTERNATIONAL update
ideation and dutasteride was not
established based on the reviewed
data, dutasteride works in the
same way as finasteride. Therefore,
information about the mood
changes seen with finasteride will
also be added to dutasteride’s
product information as a precaution.

The review found no evidence
linking suicidal ideation to
finasteride skin sprays and no new
information is being included in
the product information for these
sprays. Finasteride 1mg tablets and
finasteride skin spray are used to
treat early hair loss due to male
hormones, while finasteride 5mg
tablets and dutasteride 0.5mg
capsules are used to treat
benign prostatic hyperplasia, a
condition in which the prostate is
enlarged and can cause problems
with urine flow.