Evaluation of the reproductive toxicity potential of herbal medicine


Siti Amrah Sulaiman


Traditional & Complementary Medicine Exhibition 2007 (TCME 2007), Putra World Trade Centre (PWTC), Kuala Lumpur, Malaysia




Data not available


Reproductive toxicity study is one of the requirements in drug development. Testing of new drugs on animals for their effects on reproduction has been mandatory since the thalidomide disaster, even though the extrapolation of the findings to humans is uncertain. Reproductive studies have to be extensive because of the diversity of physiological processes that may be affected, and because of error in this field are potentially horrific. Herbal medicine contains various macro- and micro-molecules that could be hazardous to male and female reproductive systems, the gonads, the zygotes or the growing fetuses. These may lead to infertility or impaired libido to the couple, fetal death or abnormal physical or neurological development to the offspring. The preclinical reproductive toxicity evaluation of herbal products therefore should be incorporated into the research and development of herbal medicines. The conduct and interpretation of animal studies should be in accordance with the international agreements. Our experience in evaluating the reproductive toxicity potential of local herbal products indicates that some of these products are teratogenic and toxic to the reproductive system in rats. A complete preclinical safety evaluation of herbal medicine including assessment on reproductive system therefore should be performed to help practitioners and public understand the level of safety of each herbal product.