PHARMACOVIGILANCE OFF THE BEATEN TRACK - DRUG SURVEILLANCE OF HERBAL MEDICINES

For several years, herbal medicines have been increasingly consumed by patients without prescription. They are traditionally innocuous but a s medicinal products they require drug surveillance in order to identi fy their risks. However, the first concern is to give them a legal sta tus, to evaluate their efficacy and to control their safety. Published data show that the risk is due either to a contaminant or to an added drug or falsification. Since 1985, the Regional Pharmacovigilance Cen tres have received about 341 reports of undesirable effects due to her bal medicines : among them 30 cases of hepatitis were reported associa ted with germander which has been not withdrawn from the French market . This example well illustrates the role of the national system and it s responsibility for collecting and evaluating ADRs due to herbal medi cines.