E-DRUG: Alert-Renal failure associated with Chinese herbal med

[srahmad@essential.org]

E-DRUG: Alert-Renal failure associated with Chinese herbal med
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Message from Professor Breckenridge, Chairman of the U.K.
Committee on Safety of Medicines

28 July 1999 

Dear Colleague,

Renal failure associated with Aristolochia in some Chinese Herbal
Medicines.

There have been two reports recently received in the UK of patients with
end-stage renal failure associated with Aristolochia, in Chinese Herbal
Medicines. In both these cases the Chinese Herbal Medicine was used for
the treatment of skin conditions. Renal failure was described in Belgium
in 1993 where over 70 cases have been reported in association with a
slimming product containing Aristolochia. 

Aristolochia species are plants which have long been used in some
Traditional Chinese Medicines. They contain aristolochic acids, which
are genotoxic carcinogens and are associated with interstitial
nephropathy. There is evidence that Aristolochia has been a contaminant
of or used mistakenly instead of other plants, in particular Stephania
(as in the Belgian cases) and Clematis (as in the UK cases), which
themselves are not associated with such toxicity.

In 1997 Aristolochia was made a Prescription Only Medicine in order to
restrict its availability. In view of the serious adverse effects, the
Committee on Safety of Medicines has advised that the import, sale and
supply of medicinal products containing Aristolochia should be
prohibited immediately. A banning order will come into force on 28 July
1999 and will expire at the end of 27 October 1999. In the meantime, the
Medicines Control Agency is consulting on a permanent order. The
Medicines Control Agency is sampling and testing certain Chinese Herbal
Medicines to gain information on the extent of the problem of
contamination or substitution, so that appropriate provisions in respect
of such medicines can be included in a permanent banning Order.

The use of Aristolochia contained in Chinese Herbal Medicines should be
considered as a possible cause in patients presenting with unexplained
renal failure and/or interstitial nephropathy. Patients who have any
concern should be advised to consult their herbal practitioner as to the
identity of the herbal medicines they have been prescribed. We have now
been informed that, as a precaution, herbal practitioners and suppliers
are suspending the use of ingredients whose Chinese names are Mu Tong
and Fangji until appropriate quality checks are in place, because of the
risk that they may contain Aristolochia.

Health professionals who suspect that one of their patients has suffered
an adverse reaction to any herbal medicine should report this to the
Medicines Control Agency/Committee on Safety of Medicines through the
Yellow Card Scheme.

Should you require any further information, please contact Dr Charlotte
Hawkins at the Medicines Control Agency on 0171 273 0264.

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