Local case report
A 31 year-old female patient was reported to have developed symptoms of lead poisoning after the consumption of a traditional Indian medicine, Endopile® for one month. She presented with abdominal pain, nausea, vomiting, anaemia with basophilic stippling and Burton's Line (a bluish line on the free border of the gingiva). Upon hospitalisation, she was found to have a blood lead level of 4.78mmol/L (normal upper limit: 0.4mg/L or 1.93 mmol/L1).
Endopile® is produced by two firms in India, Santhigiri Ayurveda and Siddha Vaidyasala. It is available as a yellow and pink capsule. The product is indicated for the treatment of piles and related symptoms and labelled to contain herbal ingredients.
Laboratory analysis of Endopile® capsules conducted by HSA found the product to contain lead at more than 100 times the permissible limits (limit is 20ppm) and mercury at 8 times the permissible limits (limit is 0.5ppm). HSA has since taken actions to recall the affected batch of product from the local market.
Presence of heavy metals in traditional medicines
As certain branches of traditional medicine believe in using small amounts of heavy metal to treat specific ailments, it is not uncommon to find traces of heavy metals in traditional medicines such as Ayurvedic medicine. According to the principles of Ayurvedic medicine, heavy metals are used in a detoxified state in these medicinal products because of their reputed therapeutic properties. However, should the detoxification process not be strictly followed during manufacturing, it is possible for the resulting product to contain high levels of heavy metals.2
The presence of heavy metals such as lead, arsenic and mercury in traditional medicines has been reported worldwide with numerous literature published on this topic.3-7 For instance, the December 2004 issue of the Journal of the American Medical Association (JAMA) reported a study of commercially available Ayurvedic medicinal products sold in the Boston area, USA which found that 14 out of 70 (20%) of these products contained potentially harmful levels of lead, mercury and/or arsenic.8
Conclusion
With the increasing popularity of the use of traditional medicines, healthcare professionals need to be vigilant of the possible adverse effects arising from the consumption of such products. A thorough medication history inclusive of the patient's use of traditional medicines is important when evaluating a suspected adverse drug reaction. All healthcare professionals are encouraged to report suspected adverse reactions to traditional medicines to the Pharmacovigilance Unit of the HSA.
References
- Klasco RK (Ed): TOMES® System (electronic version). Thomson Micromedex.
- Media Advisory by Health Canada on Ayurvedic products containing high levels of heavy metals. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_09_e.html
- Eur J Clin Pharmcol 2002; Feb; 57(12):891-6.
- Postgrad Med J 1994; Feb; 70(820):113-4.
- Med Lav 2005; Mar-Apr; 96(2):126-33.
- Med J Aust 1992; Dec;157(11-12):835-6.
- Adverse Drug React Toxicol Rev 2002; 21(4):219-29.
- JAMA 2004; Dec; 292(23):2868-73.
- Virginia Medical Monthly 1960; Jan; 87:31-32.



