ABSTRACT
Background: Diabetes mellitus represents a global pandemic. Various pharmacotherapy and non-pharmacotherapy measures are advocated for its control. The latest in the pharmacotherapy are Sodium Glucose Transporter -2 (SGLT-2) inhibitors, widely used. Many studies suggest adverse effects related to SGLT-2 inhibitors, evidence still not conclusive and few data from India. Hence this study was planned.Methods: Cross-sectional study over a period of 02 months, recorded demographic details and history of various adverse drug reactions reported with the use of SGLT-2 inhibitors.Results: Majority of the study participants were females (58%) and belonged to the age group of 40-70 yrs. Urinary tract infections (UTI) and genital infections was more seen in the users of dapagliflozin, followed by empagliflozin and canagliflozin.Conclusions: SGLT-2 Inhibitors offer a unique therapeutic approach to the management of Diabetes Mellitus. Further evaluation of the safety profile and the risk-benefit analysis is the need of the hour.
ABSTRACT
Background: Pharmaceutical companies used Drug Promotion Literatures (DPLs) as a major tool to advertise their new products. World Health Organization (WHO) has set some guidelines for promotion of drug literature. Thus, this study aimed to evaluate various DPLs for their accuracy and credibility as per WHO ethical criteria.Methods: This was an observational and cross-sectional study. Total 100 drugs advertisements published in various medical journals were collected from the library of the college. Advertisements were selected based on inclusion and exclusion criteria. The selected advertisements were evaluated based on the WHO ethical criteria for drug promotion.Results: From 100 advertisements, 73 were single drug whereas 27 were fixed drug combinations. Antimicrobials (16%) were the most promoted advertisements. Only 28% of the advertisements carried references to support their claim. Out of which majority (91.78%) were from journal articles. The generic name, brand name, names of active ingredients, manufacturer, distributor and dosage regimen were mentioned in majority of advertisements. Drug interactions (12%), contraindications (22%), precautions (24%) and side effects (22%) were least mentioned in the advertisements.Conclusions: It was observed that none of the advertisement followed all the guidelines laid down by WHO. Pharmaceutical companies should follow ethical regulatory measures to promote their product in various journals. The regulatory authority must ensure the pharmaceutical companies to follow ethical guidelines for publishing various drug promotional literatures.