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Table 6 Details of subjects with severe, serious or medically important psychiatric adverse events following tafenoquine [74]

From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review

Study identification (indication) [refs.]Study designDoseEvent preferred term (severity or verbatim terms)OnsetDurationResolutionRelationship to study drug by the InvestigatorIntervention/action takenMedical history
SB252263/043 (prophylaxis) [89]R, DB, PC750 mg cumulativeSuicidal behaviour (associated with alcohol intoxication)aDay 81 day after tafenoquine discontinuedResolvedRelated (chloroquine co-suspect)bHospitalized and required corrective therapy (intervention unknown)/withdrawn due to unstable mental stateFamily reported history of marital difficulties and previous suicide threat; no other relevant history or concomitant medications reported at screening
SB252263/050 subject A (volunteers) [90]R, DB, PC350 mg single doseAcute psychotic episode (severe)Day 2425 daysRecoveredPossibly relatedHospitalized following progressive emotional distressTwo previous episodes of psychosis (not disclosed at screening)
SB252263/050 subject B (volunteers) [90]R, DB, PC500 mg single dosePsychotic episode (severe)Day 89 daysRecoveredRemotely relatedHospitalized for a pre-scheduled psychiatric admissionRecent diagnosis of schizophrenia (not disclosed at screening)
SB252263/014 (volunteers) [unpublished]R, O, PG1200 mg cumulativeParanoid hallucinotic psychosis (serious)Day 273 daysNot resolvedUnrelatedHospitalized and treated with olanzapine and lorazepam/noneHistory of “hallucinotic psychosis” 6 months earlier (not disclosed at screening); no obvious signs of psychosis at screening; negative drug screen
TAF112582 part 1 (P. vivax relapse prevention) [9]R, DB, PC600 mg single doseDepressed moodDay 6UnknownResolvedUnrelated (chloroquine co-suspect)bHospitalized (on day 88 for 2 days) with nausea, epigastric pain, diarrhoea, and depression; treated with fluoxetine; consulted with psychiatric specialist (findings unknown)History of depression but no suicidal tendencies; irregular psychiatric consults; frequent but irregular use of diazepam (10 mg)
TAF114582 (volunteers) [91]R, SB, PC, AC600 mg single doseDepressed mood (mild)Day 43 daysResolvedRelatedNoneNo relevant past medical history or concomitant medications were reported; at the time of the event, subject also reported abdominal pain, diarrhoea, and palpitations
SB252263/033 (prophylaxis) [7]R, DB, AC1200 mg cumulativeDepression (moderate)Day 2487 daysResolvedRelatedRequired corrective therapy (paroxetin)/withdrawn from studyClosed head injury 3 years prior to study
SB252263/057 subject B (volunteers) [92]R, DB, PC1600 mg cumulativeDepressed mood (mild)Day 3715 daysResolvedUnlikely relatedNoneNo relevant past history; treated for a UTI with sulfamethoxazole starting on day 13 (co-suspect)
SB252263/057 subject A (volunteers) [92]R, DB, PC5200 mgc cumulativeBipolar depression (mild); depression (mild)Day 223 (62 days since last dose)Lost to follow-upUnknownUnlikely relatedBupropion and lithium started on study day 223 (ongoing)/excluded due to a positive hepatitis/HIV screenNo relevant past history or concomitant medications
  1. UTI urinary tract infection, R randomised, SB single blind, DB double blind, PC placebo controlled, AC active controlled, O open label, PG parallel group
  2. aFamily reported that subject had taken “poison.” The event was not assigned a body system and therefore does not appear in the pooled output for adverse events within the psychiatric disorders classification
  3. bThe sponsor considered chloroquine co-suspect
  4. cLoading dose 200 mg/day for 3 days plus 200 mg weekly for 23 weeks