ABSTRACT

The popularity of botanical products in the United States is reflected in a survey on complementary and alternative medicine that showed that American consumers had spent an estimated $5.1 billion on botanical products in 1997 (1). In the same year, the global market for botanical medicinal products was estimated to be approximately $20 billion (2,3). It has been estimated that currently more than 1500 botanical products are available in the U.S. market alone (4). This popularity has been fueled, in part, by the perception that botanicals are naturally derived products, and hence are safe and devoid of adverse effects. This perception appeared to be justified by a paper summarizing the fatality of pharmaceutical drugs and botanical products in the 1981-1993 period, in which statistics compiled by the National Center for Health Statistics, the American Association of Poison Control Centers, Centers for Disease Control and Prevention, the Journal of the American Medical Association, and the U.S. Consumer Product Safety Commission showed an annual mortality rate of 100,000 deaths

for pharmaceuticals and none for botanical products (5). However, because the information covered was only to the end of 1993, this report did not take into consideration the subsequent fatalities attributed to Ephedra and ephedrine products. With the increase in the number of incidents of adverse reactions being reported, a database on adverse reactions of botanical products has been created as part of the World Health Organization (WHO) International Drug Monitoring System (6).