The availability and validity of safety information of Over the Counter herbal products for use in diabetes in Sri Lanka: a cross sectional study.

摘要

The availability and validity of safety information of Over the Counter herbal products for use in diabetes in Sri Lanka: a cross sectional study. Background: There is an increase of over-the-counter (OTC) herbal products for use in diabetes mellitus.. The aim of this study is to evaluate the safety information provided with OTC herbal remedies intended for diabetic patients in Sri Lanka and to assess the completeness of the information provided. Methods: Inclusion criteria consisted of OTC herbal remedies meant for use in diabetes. They were bought from local Sri Lankan super markets and non-Ayurvedic pharmacies and product information regarding the risk of hypoglycaemia, precautions for use, adverse events, dose and interactions were assessed using a scoring system. The accuracy of the information was then compared against published data. Results: Eleven products fulfilled the inclusion criteria. Five products contained a single constituent and 5 contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycaemia. Nine out of eleven products (81.8%)carried Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority.