Risks associated with vortioxetine in the established therapeutic indication

Background: Vortioxetine is approved for the treatment of Major Depressive Disorder (MDD). However, the safety of this drug in a large group of populations is still unclear. Thus, we have tried to analyze the risk profile of vortioxetine.

Material and methods: The data related to the risk profile of vortioxetine has been extracted from Pub-Med from January 2014 to May 2019. The adverse drug reactions (ADRs) have been categorized into a listed and unlisted categories as per Summary of product characteristics (SmPC) of the innovator. Further, unlisted ADRs have been analyzed as per Naranjo Scale.

Results: The galactorrhea, hyperprolactinemia, glycolimia, exacerbation of anxiety, weight gain, edema, excessive itching, petechiae, and ecchymoses have been observed with the use of vortioxetine and falls under the unlisted category. Further, the causality assessment results have shown probable relation between vortioxetine and galactorrhea, hyperprolactinemia, edema, excessive itching, ecchymoses, and petechiae. The weight gain, glycolimia and exacerbation of anxiety have a possible relationship with vortioxetine. The common ADRs observed with the use of vortioxetine are nausea, diarrhea, constipation, vomiting, pruritus including pruritus generalized, abnormal dreams, and dizziness.

Conclusion: In conclusion, more data is required to establish the strong relationship between vortioxetine and reported unlisted ADRs.

Keywords: Adverse drug reactions; Major Depressive Disorder (MDD); Marketing Authorization Holder(MAH); Regulatory Authorities (RAs); Summary of Product Characteristics (SmPC).; Vortioxetine.