Analysis of products suspected of containing Aristolochia or Asarum species

Risk assessment of plant food supplements and other herbal products containing aristolochic acids using the margin of exposure (MOE) approach

“…The amount of AAs detected in the positive samples was comparable and within the range of what was reported based on an analysis of samples on the Dutch market 9 years ago (Martena et al 2007) and also for samples collected in other countries including China, Australia, Japan, Korea, Taiwan and the United States (Hashimoto et al 1999;Lee et al 2002;Schaneberg & Khan 2004;Cheung et al 2006;Chan et al 2007;Vaclavik et al 2014). The levels detected were also comparable with the levels of AAs found in the weight-loss regimen given to Belgian patients who developed AAN resulting in EDIs of 7-31 µg kg -1 bw day -1 (Vanhaelen et al 1994;Bieler et al 1997).…”

“…In total, 206 out of 573 (36.0%) samples were positive for the presence of AAI, AAII or both AAs (see the supplemental data online). From 573 samples, 55 were purchased via online markets (Schaneberg & Khan 2004;Vaclavik et al 2014), of which 12 samples (22%) tested positive for the presence of AAI and/or AAII. The other samples were purchased from local markets in different countries, including Belgium (Vanhaelen et al 1994;Bieler et al 1997), China and/or Japan, Korea and Taiwan (Hashimoto et al 1999;Huang et al 2005;Wei et al 2005;Hsieh et al 2006;Koh et al 2006;Zhou et al 2006;Kuo et al 2010;Lee et al 2002;Xu et al 2013), Australia (Cheung et al 2006), Hong Kong (Zhao et al 2008;Wang & Chan 2014), the Netherlands (Martena et al 2007), and Switzerland (Ioset et al 2003).…”

“…The MOE values thus obtained for S2, S4 and S9, presented in Table 5, were below 10,000, indicating a priority for risk management (EFSA 2005). In addition, MOE values were also calculated for the collected literature data presented in the supplemental data online (Vanhaelen et al 1994;Bieler et al 1997;Hashimoto et al 1999;Lee et al 2002;Schaneberg & Khan 2004;Huang et al 2005;Cheung et al 2006;Hsieh et al 2006;Zhou et al 2006;Martena et al 2007;Zhao et al 2008;Kuo et al 2010;Xu et al 2013;Vaclavik et al 2014;Wang & Chan 2014). Figure 4 shows the calculated MOEs based on the three samples analysed in the present study and the 159 samples reported in the literature for which actual levels of AAs were available enabling calculation of the respective EDIs.…”

“…The sale of AA-containing botanical products was also prohibited in several other countries such as Australia, Canada and New Zealand, and in many Asian countries (e.g., Japan) (IARC 2002;Medsafe 2003;Martena et al 2007). In spite of this, PFS and traditional medicines containing AAs appear to be still available in markets (Lee et al 2002;Schaneberg & Khan 2004;Chan et al 2007;Martena et al 2007;Vaclavik et al 2014).…”

<b>Editorial:</b> Safety of Traditional Medicines, Complementary and Alternative Medicines in Africa

“…Cases of nephropathy involving substitution of Aristolochia fangchi and Stephania tetrandra, and substitution of Aristolochia manshuriensis stem for the stem of Clematis and Akebia species (EMEA, 2001) have been reported. Recent report of the detectable amounts of aristolochic acid I and II in 24.0% of the Traditional Chinese Medicines containing either Aristolochia or Asarum as an ingredient despite the fact that FDA has advised industry to remove products on the market thought to contain aristolochic acid since 2001, products are still present on the market for consumption (Schaneberg and Khan, 2004). There is evidence that "where poisoning from traditional medicines has been reported, it is usually because the plants used have been misidentified in the form in which they are sold, or incorrectly prepared and administered by inadequately trained personnel" (Fennell et al, 2004).…”