Category C—Is not a major teratogen. One animal study has shown that fluoxetine can produce changes, perhaps permanently, in the fetal brain; may adversely affect embryonic development. Two large case-control studies did find increased risks for some birth defects, but the absolute risk appears to be small. SSRIs in general have been associated with several developmental toxicities, including spontaneous abortions, low birth weight, prematurity, neonatal serotonin syndrome, neonatal behavioral syndrome (withdrawal), possibly sustained abnormal neurobehavior beyond the neonatal period, respiratory distress, and persistent pulmonary hypertension of the newborn (PPHN).
Highest RID (1.6-14.6%) among the SSRIs; ∅AE's have been reported for majority of fluoxetine-exposed infants; conflicting reports about effects on growth curves; the American Academy of Pediatrics classified the effects of fluoxetine on the nursing infant to be unknown but may be of concern
Start low with dosage ↑ of 10 & 20 mg q several weeks; can cause agitation, sleep disturbances, & ↑CNS stimulation in elderly.
Use with caution in patients with severe renal impairment
Administer a lower dose or less frequent dosing interval due to long t½