Safety Assessment of Deutetrabenazine: Real-World Adverse Event Analysis
Author Information
Author(s): Shu Yanping, Wang Yuanhe, Liu Jiaoying, Hu Lingyan, Tong Sichao, Wu Gang, Zhu Xianlin
Primary Institution: Department of Psychiatry of Women and Children, The Second People’s Hospital of Guizhou Province, Guiyang, China
Hypothesis
What are the safety signals associated with deutetrabenazine based on real-world data?
Conclusion
Deutetrabenazine may cause potential adverse effects that need to be monitored in clinical practice.
Supporting Evidence
- 3,583 adverse events were reported with deutetrabenazine as the primary suspect drug.
- Positive signals were found in psychiatric and neurological disorders.
- Common adverse events included dyskinesia, depression, and suicidal ideation.
Takeaway
This study looked at how safe a medicine called deutetrabenazine is by checking reports of side effects from many people who used it.
Methodology
Adverse events were collected from the FAERS database and analyzed using multiple data mining techniques.
Potential Biases
Consumer reports may be less accurate than those from healthcare professionals.
Limitations
The study relied on consumer reports, which may lack comprehensive information, and most reports were from the United States.
Participant Demographics
60.48% female, 29.03% male, with a majority of reports from the 45-65 age group.
Digital Object Identifier (DOI)
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