Identification of undeclared synthetic drugs in herbal products commercialized in Brazil

The adulteration of herbal products with undeclared synthetic drugs was recently described in many countries [1]. A product called „Indiano Talún“, with the complementary descriptions: „C. DA ÍNDIA TALÚN“, „is a plant used to treat back pain, arthritis, osteoarthritis ...“ besides „Registration free Product. Decrete 79994/77 Art.28 and 29 Law. 7.370“ was involved in several intoxications in Southern Brazil [2]. The product does not meet the obligatory declarations according to Brazilian law and was therefore declared as illegal, since it has no registration. The analysis of two „Indiano Talún“ samples was performed. The content of 15 capsules from each sample was extracted three times with methanol. The methanolic extracts were concentrated, affording 920mg residue for sample A and 1.0g for sample B. Both were analysed by TLC in different systems. Sample A presented two main compounds and sample B, four. Both extracts were fractionated by column chromatography and from each sample one compound was isolated. UV, IR and NMR spectra were obtained and the structures elucidated as piroxicam (A) and ketorolac (B). These nonsteroidal anti-inflammatory agents possess several adverse effects and drug interactions, with increased risks for elderly [3], what could explain the severe intoxications registered. The production and commercialization of „Indiano Talún“ was forbidden by the National Agency of Health Vigilance (ANVISA) in June 2006 [4], but after some time besides „Indiano Talún“ another product called „Fator P“, with similar package and labeling, could be found in the market. TLC comparative analysis allowed the identification of „Fator P“ as being similar to sample (A). Both „Indiano Talún“ and „Fator P“ are still being commercialized, mainly through internet and also in other regions of the country. These results confirm the urgent need for more intensive surveillance by health authorities and for a specific regulation concerning commerce of health products in the internet.

References: [1] Ernst, E. (2002) J. of Intern. Med. 252: 107–13. [2] Centro de Informações Toxicológicas de Santa Catarina. CIT/SC (unpublished data). [3] Lacy, C.F. et al. (2000) Drug Information Handbook. Lexi-Comp/American Pharmaceutical Association. Hudson (Cleveland). [4] http://www.anvisa.gov.br/inspecao/medicamentos/apreendido_2006.htm