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Forskolin-induced Swelling in Intestinal Organoids: An In Vitro Assay for Assessing Drug Response in Cystic Fibrosis Patients
Published on: February 11, 2017
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Suicidal behaviour and CFTR modulators: A case series and WHO database disproportionality analysis.
Inès Nidegger1, Julie Macey2, Marine Ferey3
1CHU de Bordeaux, Service de Pharmacologie Médicale, Centre Régional de Pharmacovigilance de Bordeaux, F-33000 Bordeaux.
Summary
Elexacaftor, tezacaftor, and ivacaftor (ETI) therapy for cystic fibrosis is linked to increased suicidal behavior reports. Further research is needed to explore a potential dose-dependent effect.
Area of Science:
- Pharmacovigilance
- Psychiatry
- Medical Safety
Background:
- Elexacaftor, tezacaftor, and ivacaftor (ETI) is a highly effective cystic fibrosis (CF) therapy.
- Recent safety concerns highlight potential psychiatric adverse events associated with ETI.
- This study investigates suicide attempts in CF patients treated with ETI.
Purpose of the Study:
- To report cases of suicide attempts in patients receiving ETI.
- To investigate the potential causal link between ETI and suicidal behavior using a global pharmacovigilance database.
- To assess dose-dependent effects and compare psychiatric risks with other CFTR modulators.
Main Methods:
- Case series describing four suicide attempts/self-injury events post-ETI initiation.
- Disproportionality analysis using Vigibase (WHO database) to assess ETI's association with suicidal behavior.
- Calculation of Reporting Odds Ratio (ROR) and sensitivity analyses, including dose-response evaluation.
Main Results:
- Four cases of suicide attempt/self-injury were reported between 3-13 months after ETI initiation.
- ETI showed a statistically significant association with increased reporting of suicidal behavior (ROR 2.5).
- A signal for suicide attempts was observed (ROR 1.4), while ivacaftor/lumacaftor was linked only to suicidal ideation.
Conclusions:
- ETI treatment is associated with a higher likelihood of reported suicidal behavior in CF patients.
- A potential dose-dependent relationship warrants further investigation.
- This finding underscores the importance of psychiatric monitoring during ETI therapy.
Keywords:
AttemptedCystic fibrosisDrug-related side effects and adverse reactionsEpidemiologyPharmacovigilancePsychiatrySuicideMore Related Videos
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