| |
2003/09/04
The probe, by the European Agency for the
Evaluation of Medicinal Products, was sparked by a major study
which pointed to increased cancer risks.
In theory, the agency has the powers to order some types of
HRT - which relieves menopause symptoms - to be taken off the
market.
Its experts are expected to report back before the end of the
year.
The recent "million women study" published in The
Lancet suggested that long-term users of certain types of HRT
had double the risk of breast cancer.
Some governments have already taken action to limit the use
of HRT as a result - in Germany, authorities say they will
restrict it to women with the most severe menopausal symptoms,
and at as low a dose and for as short a duration as possible.
Informal action
The agency cannot launch an official probe without a request
from a member government, and this has not been tabled, so
this is an informal investigation.
If the panel of experts appointment by EMEA decides that HRT
presents a "public health risk", then it can recommend
that a formal investigation is launched.
Should that go ahead, it could take anything from a few months
to well over a year.
However, the agency has sweeping powers to take pharmaceuticals
off the shelves in every EU country.
It can also place restrictions on the use of drugs which are
binding in every country.
Extra cases
Researchers estimated that HRT use caused 20,000 extra cases
of breast cancer in the UK over the last decade in women aged
50 to 64.
Three-quarters of these could be blamed on "combined" HRT
formulations - a mixture of the hormones oestrogen and progestogen.
Single hormone HRT based only on oestrogen presented less of
a risk, the study found.
In the UK, at least 1.5 million women take HRT, and half of
these are estimated to be taking "combined" versions.
EMEA spokesman Martin Harvey told BBC News Online : "We
felt this was something that the agency couldn't just ignore,
even though no-one has formally referred it to us.
"So if our panel think there are grounds for a formal
investigation, our recommendation will be a hint to the members
that this
is needed."
© BBC MMIII BBC NEWS
|