ELI LILLY DRUG.................(Eli Lilly makes thimerosal)
Sharing with you this startling news report on Prozac [aka FLUOxetine]
(these drugs are fluoride based drugs - see list of some at the end........)
Sunday Herald - 21 November 2004
Trial finds that Prozac may stunt children's growth
25,000 young Britons prescribed drug
By Liam McDougall, Health Correspondent
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
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
"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 be published 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."
Copyright © 2004 smg sunday newspapers ltd. no.176088
Avoid fluoridecontaining drugs : If you are taking the following, contact
for a fluoride-free alternative:
(fluoxetine), Rohypnol (flunitrazepam), Diflucan
(fluconazole, Flixonase or Flixotide
(fluticasone), Stelazine (trifluoperazine, Fluanxol or
Depixol (flupenthixol) or Floxapen
(flucloxacillin) and asthma drugs that use propellants
containg fluoride: Ventolin and Becotide
CIPRO: another nasty fluoroquinolone
Two antimalarial drugs quinacrine and chloroquine