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Update on Congenital Eye Malformations Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting J PowerPoint Presentation
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Update on Congenital Eye Malformations Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004. Solomon Iyasu, MD, MPH Medical Team Leader Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration.

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Update on Congenital Eye MalformationsPediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004

Solomon Iyasu, MD, MPHMedical Team Leader

Division of Pediatric Drug DevelopmentCenter for Drug Evaluation and Research

Food and Drug Administration

acknowledgment
Acknowledgment

Kathleen Phelan

DDRE, Office of Drug Safety

background
Background
  • Feb 2-3, 2004 Pediatric Advisory Subcommittee Meeting
    • Reported one case of eye malformation during the one-year post-exclusivity AE review for citalopram (Congenital ptosis, eye muscle paresis, nystagmus)
  • Today’s update:
    • Review of all reports of congenital eye malformations for citalopram and its enantoimer, escitalopram since market approval (1998)
    • Review of AEs for other newer antidepressants
background4
Background
  • WHO Upsala Monitoring Center Drug Safety Bulletin (March, 2002):
    • 3 case reports of Congenital Eye Malformations
      • Optic nerve hypoplasia (2),
      • Eye malformation NOS (1)
    • Suspect drug: Citalopram maternal exposure during the first trimester
relevant product labeling
Relevant Product Labeling
  • Citalopram: Pregnancy Category C
    • Animal studies show teratogenic effects at maternally toxic dose in rats.
  • Fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine (all pregnancy category C)
relevant product labeling6
Relevant Product Labeling
  • Bupropion: Pregnancy Category B
  • Desipramine: No Pregnancy Category included in labeling; statement under “Warnings” about use in pregnancy
aers search
AERS Search
  • ODS searched AERS database for reports of “eye disorders, congenital” in relation to citalopram, escitalopram and other newer antidepressants
aers search results for citalopram
AERS Search Results for Citalopram
  • 5 unduplicated pediatric eye malformations (1 US, 4 international)
    • Congenital optic nerve hypoplasia (other meds: cefuroxime, nitrofurantoin for UTI about the 5th month of pregnancy)
    • Non-specific eye malformation (multiple meds)
    • Congenital ptosis and nystagmus (no other meds reported)
    • Bilateral retinal coloboma, right hydronephrosis, respiratory distress syndrome, collapsed lung (other meds: multivitamins)
    • Downward deviation of gaze without paralysis (no other meds reported)
  • No reports with escitalopram use
  • 1 case of congenital optic nerve hypoplasia reported in the WHO bulletin was not found in AERS
aers search of other anti depressants
AERS Search of Other Anti-depressants
  • Bupropion: lacrimal duct obstruction (1), eyelid malformation (1)
  • Fluoxetine: optic nerve anomaly (1), congenital lacrimal passage anomaly (1)
  • Paroxetine: retinopathy (1), congenital cataract (1)
  • Sertraline: eye deformity (1), anomaly of orbit (1), lacrimal passage anomaly(1)
  • Desipramine, fluvoxamine, venlafaxine: No case reports
comments
Comments
  • Reported AEs of congenital eye malformations do not constitute a recognizable pattern attributable to use of citalopram or other antidepressants during pregnancy
  • Monitoring of AERS for pediatric reports of eye malformations will continue