Healthy Skepticism Library item: 5163

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Charities positive about Prozac use
PMLive.com (Pharmaceutical Marketing Ltd) 2006 Jun 13
http://www.pmlive.com/pharm_market/news.cfm?showArticle=1&ArticleID=4671

Full text:

Children’s and mental health charities have reacted positively to
recommendations from the European Medicines Agency (EMEA) for the use
of
Prozac in children over eight years old if talking therapies and other
forms
of counselling do not work.

“While medication for the young should always be monitored, depression
in
children can be so destructive to their future and harrowing for their
families that no treatment should be ruled out,” said Marjorie Wallace,
chief executive of the mental health charity, SANE.

“All medication, if effective, must be considered on a balance of risk
and
benefit. We should not deprive children any more than we should deprive
adults of available means of saving at least some many years of
loneliness
and despair,” she added.

However, YoungMinds, the national charity dedicated to the mental needs
of
children and young people, has said that prescription medication should
never be the first course of action, but admitted that there may be
specific
circumstances where psychological treatment alone is not effective for
the
child.

“Whenever children experience mental illness an holistic approach to
treatment and care is essential. This would include a package of care
designed to ensure the best chance of recovery. After careful
consideration
and consultation with the child, their family and medical team, such
treatments may be offered alongside other therapy,” said YoungMinds’
development director, Avis Johns.

“Though quite rare, the ability to combine a range of therapies with
appropriate medication can provide significant benefits,” she added.

The European regulator has adopted a positive view on the use of Prozac
and
associated names for use in children and adolescents with
moderate-to-severe
depression, after its Committee for Medicinal Products for Human Use
(CHMP)
concluded that the benefits of using Prozac for this indication
outweigh its
potential risks.

Lilly filed an application to extend the indications to include major
depressive episodes in children after a request from the UK. The
company,
which holds the marketing authorisation for Prozac for use in adults,
first
launched the product in 1986.

A licence for the product in this expanded indication has not yet been
granted. The EMEA is meeting in August to discuss marketing
authorisation
for the product for use in children and there is every reason to be
believe
that it will be granted, as it is unusual for the regulator to rule
against
advice.

However, under licence, the EMEA will impose restrictions on the use of
Prozac, the only selective serotonin re-uptake inhibitor (SSRI) the
Medicine
and Healthcare products Regulatory Agency has exempted from its general
ban
for use in children, which stipulate that the drug cannot be prescribed
for
use in children unless talking therapies have failed.

The regulator is also likely to impose other caveats on use of the
product
on advice from the CHMP which, as well as advising its use only in
patients
who do not respond to talking therapies, concluded that the starting
dose
should be 10mg per day (given as 2.5ml of oral solution) and may be
increased to 20mg per day after 1-2 weeks, and treatment should be
reconsidered after 9 weeks if there is no clinical benefit. In
addition,
Lilly has been told to put in place a system to obtain safety data in
children taking Prozac, with particular emphasis on sexual development.

The CHMP has confirmed that doctors and parents should carefully
monitor
children and adolescents for suicidal behaviour, particularly at the
beginning of their treatment.

Message to healthcare professionals
For healthcare professionals, the potential licensing approval for
Prozac in
this new indication represents a new stage in the treatment of
depression in
children. However, as the drug is not a first line treatment,
healthcare
professionals are unlikely to need re-educating as to its uses.

“Prozac is not intended as a first line treatment for children,” said a
spokesman for Lilly UK. “They will first have to have 4-6 talking
therapy
sessions. If this is not sufficient, a low dose of Prozac can be
prescribed,
alongside more counselling. Our message [should a licence be granted]
will
be to reinforce this.”

He stressed that “Prozac is for moderate-to-severe depression, it’s not
just
for those who feel a bit down, but for those who are potentially
suicidal”.

For Lilly, the possibility of an expanded licence for Prozac, which has
been
off-patent and subject to generic erosion for a number of years, will
have
little impact.