16/05/2005 - The Environment
Agency is asking manufacturers of the antidepressant
fluoxetine to look at whether the chemical
is finding its way into the environment and
having an effect on wildlife.
Fluoxetine hydrochloride was first introduced
in 1988 by Lilly and Company and marketed
under the trade name 'Prozac'. Since the patent
expired in 2000, the compound has been marketed
in the UK by a number of other companies.
Last year, doctors in the UK issued over 5
million prescriptions for fluoxetine – equating
to around 4.1 tonnes of the compound.
Research suggests that once fluoxetine is
in the environment it is not easily broken
down. It can also be toxic to aquatic life
at low concentrations. Up to now, however,
because of the lack of effective analytical
methods, there has been no monitoring for
fluoxetine or its major breakdown product
norfluoxetine in the UK environment.
The Environment Agency, however, is now doing
work to develop and trial methods that will
allow the levels of these chemicals in river
water and sewage effluent to be measured.
The Agency is calling on the pharmaceutical
industry to assist in environmental monitoring,
and to undertake further research on the toxicity
of fluoxetine to aquatic life.
Derek Tinsley, the Environment Agency’s Head
of Air and Chemicals Policy said: “When people
take pharmaceuticals like fluoxetine, small
quantities can be excreted. This, and the
disposal of unwanted medicines down household
drains, creates the potential for these substances
and their breakdown products to enter sewage
works and rivers.
“Although our sewage treatment plants remove
most of these products, small quantities can
remain in the effluent that is returned to
the rivers and seas. We don’t know how much
fluoxetine is finding its way into the environment.
What we do know is that it’s a widely used
substance, its toxic to aquatic life at low
concentrations, and once in the environment
it persists for quite a while.
“Previous research backed up by our own initial
calculations suggests that fluoxetine will
not be at levels in our rivers high enough
kill aquatic life. However, we are unclear
about the longer term and subtle impacts (such
as effects on reproduction and growth) that
very low but continuous concentrations might
have on our aquatic species.
“That’s why we are asking the manufacturers
to undertake some research, so that we can
make judgements about risk to the aquatic
environment based upon sound science.”
The Environment Agency is asking the manufacturers
of fluoxetine to:
assist in monitoring the levels of fluoxetine
and norfluoxetine present in rivers and sewage
works effluents in England and Wales, and,
if these substances are found to be entering
the aquatic environment in England and Wales,
then to carry out research to assess whether
the concentrations are capable of affecting
aquatic life.
Last year, incorrect reports that the Environment
Agency had found traces of fluoxetine in rivers,
groundwater and drinking water surfaced in
the media. At the time of the reports, no
monitoring for fluoxetine had been undertaken.
The Drinking Water Inspectorate is responsible
for monitoring drinking water quality. The
Inspectorate is confident that, because of
the sophisticated water treatment systems
in place, fluoxetine would not be detected
in the public water supply.