Ban on supply of Aristolochia
Department of Health
Press Release: 1999/0466
Date: Wednesday 28th July 1999
An emergency ban on the import, sale and supply of Aristolochia,
a prescription only medicine used in Chinese Herbal Medicines,
has been announced today following two cases of kidney failure
in the UK on the advice of the Committee on Safety of Medicines.
Aristolochia is a toxic herb associated with kidney damage.
The ban will prohibit supply of any unlicensed medicinal products
containing Aristolochia, either alone or combined with any
other substances.
The emergency ban comes into force on July 28 and will expire
at the end of October 27, 1999. In the meantime, the Medicines
Control Agency (MCA) is consulting on a permanent ban.
Organisations representing Traditional Chinese Medicine suppliers
and practitioner bodies have voluntarily suspended use of
ingredients whose Chinese names are Mu Tong arid Fangji, because
of the risk that they may contain Aristolochia.
The consultation also covers a possible permanent ban on the
supply of other herbs which are prone to contamination or
confusion with Aristolochia. In advising a ban on the supply
of Aristolochia, the Committee on Safety of Medicines also
recommended that there should be sampling of supplies of some
Chinese Herbal Medicines to check that Aristolochia is not
present. Anyone taking a herbal medicine who is concerned
should consult the practitioner who prescribed it.
Notes To Editors
I. Aristolochia is a herb used in some Traditional
Chinese Medicine for the treatment of fluid retention and
rheumatic symptoms. Aristolochia has mistakenly been used
instead of Stephania and Clematis, which are not harmful and
are used for the treatment of skin conditions including eczema,
urinary problems, fluid retention or swelling and rheumatic
conditions.
2. The herb Aristolochia is known to be
toxic, causing kidney damage. This was reported in Belgium
in 1993, where more than 70 cases of kidney failure were found
to be associated with a slimming preparation, in which the
root of Aristolochia had been used mistakenly instead of Stephania.
The problem arose because both plants are described by the
Chinese name "Fangji".
3. The recently reported UK cases of kidney
failure are associated with the herbal ingredient known by
the Chinese name "Mu Tong". Mu Tong is used to describe
at least four different plants including species of Clematis,
Akebia and Aristolochia. In both cases, the Mu Tong used was
in fact the toxic species Aristolochia rather than one of
the other harmless herbs.
4. Aristolochia has been a Prescription
Only Medicine since 1997. The immediate ban will come into
force on July 28 and will expire at the end of October 27,
1999. It will be directed at supply of medicinal products
containing Aristolochia only. During the consultation exercise
the MCA will consider the evidence. Ministers will then decide
on permanent action.
5. The action now being taken on Aristolochia
is to deal with the threat posed to the public by a specific
dangerous ingredient in unlicensed herbal remedies. This is
an entirely separate issue from the MCA's proposals on borderline
products (MLX 249) which were about the MCA's arrangements
for deciding whether a product should be classified as a medicine.
6. Under exemptions in Section 12 of the
Medicines Act, these herbal medicines are not subject to the
standard controls for licensed medicines. The Medicines Control
Agency Is currently holding constructive dialogue with a wide
range of organisations across the natural health sector about
the case for a future regulatory approach to herbal medicines
which would achieve a more effective balance between consumer
choice and consumer safety.
7. Herbal practitioners supply many herbal
medicines, including Traditional Chinese Medicines (TCM).
As a precautionary measure, organisations representing Traditional
Chinese Medicine practitioners and suppliers have advised
their members to suspend the use of medicines containing ingredients
whose Chinese names are Mu Tong (which may be Clematis or
Akebia species) and Fangji (Stephania) until appropriate quality
checks are in place. Among the organisations giving this advice
are the Register of Chinese Herbal Medicine (RCHM), the Chinese
Medicine Association of Suppliers (CMAS) and the Association
of Traditional Chinese Medicine (UK).
8. Homeopathic licensed products derived
from Aristolochia will not be affected as these are too dilute
to carry any risk of toxicity.
9. The Committee on Safety of Medicines
(CSM) is an independent committee of experts that advises
Government on the safety, quality and effectiveness of medicines.
Department of Health
Richmond House
79 Whitehall
London SW1A 2NS
Tel: +44 (0) 20 7210 5221
Fax: +44 (0) 20 7210 5433/4
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