WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Close this folderDrug surveillance
View the documentAcetylsalicylic acid and NSAIDs - OTC availability: increased potential for adverse reactions
View the documentDrug-induced depression - review
View the documentMidazolam - paradoxical reactions in children
View the documentSelective serotonin reuptake inhibitors (SSRIs) - neonatal disorders
View the documentSumatriptan - fatal outcomes
View the documentVenlafaxine - review of adverse reactions
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine

Selective serotonin reuptake inhibitors (SSRIs) - neonatal disorders

Australia. The Adverse Drug Reactions Advisory Committee has received several reports of effects on the neonate associated with the use of selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, fluvoxamine, paroxetine and sertraline.

Four reports describe withdrawal reactions in neonates whose mothers had taken SSRIs throughout their pregnancies. These reactions were generally characterized by tachypnoea, irritability, jitteriness, fever anorexia, cyanosis and possibly convulsions. The effects in all four cases appeared to resolve spontaneously.

Another four reports relate to probable breast milk transfer since they all refer to breast-fed babies. These reports include one case of hyperglycaemia and glycosuria; two cases of agitation and one case in which the baby became somnolent, with low muscle tone, hearing problems and suspected developmental difficulties.

Reference: Australian Adverse Drug Reactions Bulletin 16(4): 14 (1997).

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