title: The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study.
abstract: OBJECTIVE
  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 supermarkets and non-ayurvedic pharmacies and product information regarding the risk of hypoglycemia, 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
  11 products fulfilled the inclusion criteria. Five products contained a single constituent and five contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycemia. 9 out of 11 products (81.8%) carried ≤3 items of the five essential factual information we expected. Hypoglycemic coma, gastrointestinal symptoms, hepatotoxicity, carcinogenesis, and interactions causing elevated drug levels of Carbamazepine were some of the safety information that was missing.
  
  
  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.
authors.affiliation: Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: Arjuna Bandara
authors.initials: AB
authors.lastname: Medagama
authors.affiliation: Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: Heshan
authors.initials: H
authors.lastname: Widanapahirana
authors.affiliation: Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: Tharindu
authors.initials: T
authors.lastname: Prasanga
keywords: Complementary and alternative medicine; diabetes mellitus; herbal remedies; safety information