What does this research mean for the field?

Amisulpride, cyamemazine, and olanzapine are associated with a potential risk of torsadogenicity, representing newly identified safety signals for these antipsychotics. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

April 3, 2013Drug SafetyOpen Access

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database

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Why the study?

Do antipsychotics increase the risk of torsades de pointes and related arrhythmias in patients reported to the FAERS database?

Population

4,794 cases of arrhythmia reported in the US FDA Adverse Event Reporting System database between 2004 and…

Comparison

Antipsychotics (37 different drugs) vs Other drugs in the FAERS database

Design

Other

Follow-up

7-year period (2004-2010)

Authors

EPElisabetta PoluzziUniversity of Bologna EREmanuel RaschiUniversity of Bologna AKAriola KociUniversity of Bologna

Discussion

Member takes

Implication

May warrant ECG monitoring with these antipsychotics; hypothesis-generating and requires prospective validation.

Structured PICO

Do antipsychotics increase the risk of torsades de pointes and related arrhythmias in patients reported to the FAERS database?

Population

4,794 cases of arrhythmia reported in the US FDA Adverse Event Reporting System (FAERS) database between 2004 and 2010 where antipsychotics were recorded as suspect or interacting.

Intervention

Antipsychotics (37 different drugs)

Comparator

Other drugs in the FAERS database (background reporting rates)

Outcome

Signal of torsadogenicity based on reporting odds ratio (ROR) for 4 groups of events: (1) TdP, (2) QT-interval abnormalities, (3) ventricular fibrillation/tachycardia, and (4) sudden cardiac death.safety

A pharmacovigilance analysis of the FAERS database identified new potential signals of torsadogenic risk for the antipsychotics amisulpride, cyamemazine, and olanzapine.

Cite This Study

Poluzzi et al. (2013) studied this question.

synapsesocial.com/papers/6a1d237aba65f5ee325ddf48 https://doi.org/10.1007/s40264-013-0032-z

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Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Also Consider

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