Adverse Drug Reaction Associated with Vitamins: An Analysis of Spontaneous Reports from Pharmacovigilance Programme of India Database

Abstract

The objective of this study was to describe adverse events with the use vitamins and to identify risk factors. A retrospective study was carried out from the spontaneous adverse drug reaction (ADR) reports for the period April 2011 to March 2013 by National Coordination Centre, Pharmacovigilance Programme of India (PvPI). 29 reports of vitamins were received by NCC-PvPI, which comprised approximately 0.064% of the total 45,297 reports received at NCC-PvPI. Among the different types of vitamins for which ADRs have been reported are vitamin A (11.43%), vitamin D (22.86%), vitamin E (14.28%), vitamin K (22.86%), vitamin B-complex (25.71%) and vitamin C (2.86%). Out of these 29 reports, 17 (58.62%) were of females and 12 (41.38%) of males. Only four cases (13.79%) were reported to be serious and rest of the cases (86.21%) were non-serious. Most of the reactions reported were recovered with 32%. The causality assessment of each ADR observed due to vitamin was done as per WHO-UMC. Vitamins are just like any other healthcare intervention – they have potential risks and benefits and it is best to follow the evidence.

Keywords: vitamin supplement, adverse drug reaction, health effects

Cite this Article

Kalaiselvan Vivekanandan, Kumar Ranvir, Thota Prasad et al. Adverse drug reaction associated with vitamins: An analysis of spontaneous reports from pharmacovigilance programme of India database. Research & Reviews: Journal of Pharmacology. 2015; 5(3): 12–18p.