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[End-stage renal insufficiency associated with Chinese herbal consumption in France]
Abstract:
In May 1994 in Toulouse, there were two cases of end-stage renal failure (ESRF) related to Chinese herbs similar to those incriminated in the case series reported in Belgium in 1992-93, they led to an epidemiologic investigation aimed at evaluating the risk linked to these plants in France. Studies carried out by the Pharmacy Inspection showed that powders labelled Stephania Tetrandra, but consisting instead of Aristolochia Fangji and containing aristolochic acid, were sold in France between 1989 and May 1994. A systematic attempt to ascertain cases of ESRF associated with ingesting Chinese herbs was carried out by analysing data from the ERA-EDTA Registry of ESRF as well as from the French adverse drug reaction monitoring system. Registry data showed no significant increase over previous years in the number of new ESRF cases caused by tubulo-interstitial nephritis (TIN) between 1990 and 1993. In eight regions of France, the files of 85 ESRF cases were examined, and all patients whose nephropathy began after 1989 were interviewed using a very detailed questionnaire. No association with Chinese herb use was found in any of these cases. In 1996, two new ESRF cases were reported in Nice; the regional adverse drug reaction monitoring center considered the relationship with Aristolochia Fangji to be as possible (I2) for one case and dubious (I1) for the other. Despite a lack of sensitivity of the methods used to detect cases, it seems clear that no phenomenon as extensive as that observed in Belgium occurred in France, although the same drugs prescribed at the same doses have been widely distributed in our country. A possible explantation for the difference in the number of cases in Belgium and France is that of an unrecognised factor, promoting the toxicity of aristolochic acid or peculiar to the Belgian clinic and causative. The precautionary principle led the authorities to ban Stephania Tetrandra and Aristolochia Fangji from the market permanently.