Adverse reactions to herbal products: An analysis of spontaneous reports in the database of the Pharmacovigilance Programme of India

Abstract Herbal products (HPs) are widely used as pharmaceutical and neutraceutical agents in India. The existing Pharmacovigilance Programme of India (PvPI) encourages reporting of adverse events related to HPs to monitor their safety. To analyze the reported adverse reactions suspected with the use of HPs all reports submitted to the National Coordination Centre (NCC) for PvPI during the period July 2011–December 2013 were assessed on the probability of a causal link between the use of the medication and the reported adverse reaction. An overview was compiled of all reports relating to severe adverse reactions. The NCC-PvPI database contained 39 reports of suspected adverse reactions to HPs in which 16 of them were classified as serious, 12 were non serious and 11 were unassessable. The cases were further categorized by system organ classification (SOC) and it was found that 52.5% were related to skin and appendages disorders. The suspected HPs were Gudmar Ameda, Shankhpushpi, Mahavat Vidhwansan, Dashmool Kwath, Shemar Yesaka, Melas cream, Senna Extract, Aloe Vera, Mustard oil, Digitalis, Garlic, Menthol and Turmeric. Causality assessment as per the WHO scale revealed that five cases were probable/likely, 17 were possible, one was unlikely and the rest of them were unassessable or blank. Healthcare providers and consumers must be educated to ensure the safe use of herbal products. Also rigorous monitoring to ensure the safe use of HPs through PvPI is essential to safeguard public health.