PFPC Daily - November 20, 2004

NOTE: On November 11, 2004 we reported on recent findings from a
study on mice which reported that Prozac inhibited bone growth in
mice.

SEE:
http://health.groups.yahoo.com/group/pfpcnews/message/225

The article below reports on findings which show the same effects in
children.
=========================

Trial finds that Prozac may stunt children's growth

25,000 young Britons prescribed drug

Sunday Herald - November 21, 2004

By Liam McDougall

A CLINICAL trial by the makers of Prozac has revealed evidence the
antidepressant could harm the growth and development of children.

The Sunday Herald has uncovered details of a 19-week trial carried
out by Eli Lilly where children aged between eight and 17 years old
who were given the drug gained an average of 1cm less in height and
1.1kg less in weight than others treated with a placebo.

The results revealed that treatment with fluoxetine, the generic name
for Prozac, was also linked to a decrease in levels of alkaline
phosphatase, an enzyme crucial to bone development.

Despite concerns from America's Food and Drug Administration
(FDA) in 2001, which requested that Lilly carry out a further
one-year trial to ensure the drug was safe to be used by children, no
such test has ever been done.

According to FDA documents seen by the Sunday Herald, Lilly refused
to carry out a more thorough trial, but was granted a licence to
prescribe Prozac to children a year later. In the FDA paper Andrew
Mosholder, medical officer for the FDA, writes: "Nineteen weeks
of fluoxetine treatment was associated with reduced growth velocity
relative to placebo.

"On balance, I believe that this trial provides evidence of
reduced growth velocity with fluoxetine treatment, and I believe
labelling should reflect the finding. In my opinion, the sponsor has
not provided an adequate rationale for declining to do a one-year
study as we requested."

British experts on psychiatric drugs last night expressed
astonishment about the trial, the results of which have never been
highlighted to doctors or printed by Eli Lilly on UK Prozac patient
information leaflets.

News about the possible harm to children comes at a time when the
Medicines and Healthcare Products Regulatory Authority (MHRA), the UK
drug licensing agency, is considering an application by Lilly to have
Prozac licensed for use on under-18s.

In the last year, thousands of British children have moved on to
Prozac after the MHRA ruled that all antidepressants in the SSRI
class, with the exception of Prozac, should be banned from use on
children. The change followed a major inquiry by the authority that
found the drugs could cause suicide.

Although Prozac does not have a licence for use on children, the
decision to ban all other SSRIs has led to a massive rise in the
number of doctors and psychiatrists prescribing the drug to children
on an "off-licence" basis. Before the MHRA ban, experts say
25,000 children under the age of 18 in the UK were being prescribed
antidepressants.

Between 2000 and 2002 the number of antidepressant prescriptions for
children soared by 68%.

Dr David Healy, director of the north Wales department of
psychological medicine, whose warnings that antidepressants could
cause suicide led to the MHRA inquiry, expressed concern at the
Prozac trial results. He said: "Very few people will have heard
of this. Doctors who are giving Prozac to children and who read the
published scientific articles won't see anywhere that clinical
trials have indicated that children on Prozac don't grow as well.

"This was flagged up by the FDA two years ago and the FDA asked
the company to do further work. It should give people who may be
thinking about using the drug, some cause for concern."

He said that in the past, trials on antidepressants had been carried
out and been reported by pharmaceutical firms "in very misleading
terms".

"In the Prozac children's trials there is evidence that the
children didn't grow and put on weight in the same way," he
said. "That's the kind of thing you just don't get to hear
about. For those who are in the process of development this is
potentially a very important issue.

"You'd have thought that in the first instance the company or
the MHRA, who are responsible for making sure these drugs are on the
market, would ensure that an appropriate label was placed on them so
that we would know what the risks are and know what to look out for.

"But when you look at the label for Prozac there is no mention of
concerns about the development of children. All it says is that this
product is not recommended for children. But the number of children
taking Prozac in the UK has increased hugely in the last two
years."

Dr Andrew Herxheimer, a clinical pharmacologist and founding editor
of the Drug And Therapeutics Bulletin, said: "I think the news
about the possible effect on children's growth is serious. The
effects
of antidepressants in children is a hugely under-researched area.

"When there are doubts the benefit of the doubt has to be given
to the patients and not to the drug. But both the MHRA and Eli Lilly
are not in the business of admitting doubt."

Dr Iain McClure a child and adolescent psychiatrist and spokesman for
the Royal College of Psychiatrists in Scotland, said that despite
prescribing Prozac to children for the last five years he had not
encountered problems with side-effects. He added: "Over the last
few years I've been using fluoxetine with young people and I have
not experienced any difficulties with side-effects and I've seen
genuine therapeutic results.

"All I can do is speak to my own clinical experience of using
fluoxetine with young people. I haven't had such evidence brought
to my attention."

Dr Harvey Marcovitch, a consultant paediatrician and associate editor
of the BMJ, said: "There is lots of information that is not
generally available and pharmaceutical companies have been accused of
publishing good news and burying bad news for years. As a journal
editor, I believe that every trial that's ever conducted ought to
bepublished somewhere regardless of whether the results are
embarrassing to somebody or not."

Andrew Day, a spokesman for Eli Lilly, said the company was designing
a "long-term" study into the effects of Prozac on
children's development. He added: "We have a clear and
transparent policy. Any and all clinical data that we have is shared
with all regulatory authorities."

A spokeswoman for the MHRA said: "Eli Lilly was encouraged to put
in a licence application for Prozac and that is being considered at
the moment."

SOURCE:
http://www.sundayherald.com/46216