Risks Associated with Vortioxetine in the Established Therapeutic Indication

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Vortioxetine is an approved medication for Major Depressive Disorder (MDD).
• The comprehensive safety profile of vortioxetine across diverse populations requires further elucidation.
• Analysis of vortioxetine's risk profile is crucial for understanding its safety.

Purpose of the Study:

• To systematically analyze the risk profile of vortioxetine.
• To identify and categorize adverse drug reactions (ADRs) associated with vortioxetine.
• To assess the causality of unlisted ADRs linked to vortioxetine.

Main Methods:

• Systematic literature review of vortioxetine safety data from PubMed (January 2014 - May 2019).
• Categorization of adverse drug reactions (ADRs) into listed and unlisted based on innovator's Summary of Product Characteristics (SmPC).
• Causality assessment of unlisted ADRs using the Naranjo Scale.

Main Results:

• Unlisted ADRs including galactorrhea, hyperprolactinemia, glycolimia, anxiety exacerbation, weight gain, edema, itching, petechiae, and ecchymoses were identified.
• A probable relationship was found between vortioxetine and galactorrhea, hyperprolactinemia, edema, itching, petechiae, and ecchymoses.
• Common ADRs include nausea, diarrhea, constipation, vomiting, pruritus, abnormal dreams, and dizziness. Weight gain, glycolimia, and anxiety exacerbation showed a possible relationship.

Conclusions:

• The study identified several unlisted adverse drug reactions associated with vortioxetine.
• Further investigation is warranted to establish definitive causal links between vortioxetine and the observed unlisted ADRs.
• Continued pharmacovigilance is essential for a complete understanding of vortioxetine's safety.