Pharmacovigilance of medicinal plants used for alimentary tract and metabolism disorders

SEREMETA, KP; TAUGUINAS, AL; BAEZ, M; GRUSZYCKI, MR

Rosario

Otro; 4ta Reunión Internacional de Ciencias Farmacéuticas (RICIFA); 2016

Universidad Nacional de Rosario/Universidad Nacional de Córdoba

In recent years the interest in medicinal plants has increased due to a trend toward the "natural"; however, they can cause adverse effects. The aim of this study was to evaluate the reports on adverse effects caused by the use of medicinal plants for alimentary tract and metabolism disorders in the adult population, received as Peripheral Provider (Department of Pharmacology, UNCAUS) of the National Pharmacovigilance System within National Administration of Drugs, Food and Medical Technology (ANMAT) of Argentina. The reports received during 2010-2015 period were analyzed using the Herbal Anatomical Therapeutic Chemical (ATC) classification. Causality of adverse events was determined using the Naranjo et al. algorithm. Severity was classified as mild, moderate and severe. Adverse/toxic effects were compared with bibliographic data. From a total of 120 reports, 75 corresponded to the adult population and according to the Herbal ATC classification, 61% were related to the HA group (alimentary tract and metabolism). Among this group, the observed distribution was: laxatives, 44%; drugs for functional gastro-intestinal disorders, 26%; bile and liver therapy, 15%; antidiarrheals, intestinal antiinflammatory/antiinfective agents 9%; antiobesity preparations, 3%; and drugs used in diabetes, 3%. Consumption was higher in women (85%) than men (15%). The most reported species were Cassia senna L. (24%), Peumus boldus (12%), Rhamnus purshiana D.C. (9%) y Psidium guajava L. (9%), among others. Concerning the causality of adverse events 69% were probable, 22% possible and 9% unlikely. Regarding the severity 62% were mild, 33% moderate and 5% severe. Adverse effects were mostly related to disorders of the gastro-intestinal system (68%), cardiovascular, general (10%), central and peripheral nervous system (9%), body as a whole, general (7%), among others. Within the group analyzed there was a predominant use of medicinal plants with laxative properties, being the most of adverse reactions probable, mild and related to gastro-intestinal system disorders.