fluvoxamine and Abnormalities--Drug-Induced

General consensus exists about the need to avoid drug intake as much as possible during pregnancy due to the lack of thorough evidence about the safety of pharmacologic treatments during gestation for both mothers and fetuses. In this respect, the overall safety profile of selective serotonin reuptake inhibitors (SSRIs) in pregnancy remains unclear. This article reviews current evidence about the safety of each SSRI during pregnancy in order to describe their specific teratogenic potential, with a particular focus on major and cardiovascular malformations, and to verify whether such toxicity can be considered as a class effect. The literature review included controlled studies and meta-analyses (retrieved using PsychINFO, EMBASE, and Medline from January 1966 to May 2010) from which the risk of major and/or cardiovascular malformations associated with a specific SSRI (ie, fluoxetine, paroxetine, sertraline, citalopram, escitalopram, and fluvoxamine) could be estimated. Although there is evidence to support the association between birth defects and first-trimester exposure to paroxetine, findings from the studies reviewed suggest a teratogenic potential of the whole SSRI class, consistent with preclinical evidence. These teratogenic effects are mainly in the heart region, and they are often described as septal defects. It may be suggested that the higher frequency of teratogenic effects reported for paroxetine might depend on specific pharmacologic features of this drug compared with other SSRIs, although it is difficult to test this hypothesis. It is noteworthy that current evidence on SSRI teratogenicity stems from studies affected by several methodological weaknesses (ie, lack of investigations using control groups of untreated depressed mothers, confounding by indication, and recall bias). Accordingly, we are not yet able to rule out the possibility that positive associations, as determined in some studies, result from analyses of poor quality.

Topics: Abnormalities, Drug-Induced; Cardiovascular Abnormalities; Citalopram; Depression; Female; Fluoxetine; Fluvoxamine; Humans; Maternal-Fetal Exchange; Paroxetine; Pregnancy; Pregnancy Complications; Selective Serotonin Reuptake Inhibitors; Sertraline; Teratogens

(1) Serotonin reuptake inhibitor antidepressants are not teratogenic in animals. (2) Human data are limited, and most involve fluoxetine. (3) No data pointing to a teratogenic effect after fluoxetine exposure during the first trimester have been reported. (4) Self-resolving neurological signs have been observed in newborns exposed to fluoxetine at the end of pregnancy. (5) The paucity of data requires all prescribers of antidepressants to pregnant women to report any adverse events occurring in a child or mother to a teratogenicity or pharmacovigilance centre.

Topics: Abnormalities, Drug-Induced; Antidepressive Agents, Second-Generation; Child; Child, Preschool; Clinical Trials as Topic; Depressive Disorder; Female; Fluoxetine; Fluvoxamine; Humans; Infant; Infant, Newborn; Paroxetine; Pregnancy; Selective Serotonin Reuptake Inhibitors; Sertraline; Treatment Outcome

Although a large number of women of reproductive age use new selective serotonin reuptake inhibitors (SSRIs) and half of all pregnancies are unplanned, no data exist on the safety of these agents for the human fetus.. To assess fetal safety and risk of fluvoxamine, paroxetine, and sertraline.. A prospective, multicenter, controlled cohort study.. Nine Teratology Information Service centers in the United States and Canada.. All women who were counseled during pregnancy following exposure to a new SSRI and followed up by the participating centers. Controls were randomly selected from women counseled after exposure to nonteratogenic agents.. Rates of major congenital malformations.. A total of 267 women exposed to an SSRI and 267 controls were studied. Exposure to SSRIs was not associated with either increased risk for major malformations (9/222 live births [4.1%] vs 9/235 live births [3.8%] in the controls, relative risk, 1.06, 95% confidence interval, 0.43-2.62) or higher rates of miscarriage, stillbirth, or prematurity. Mean (SD) birth weights among SSRI users (3439 [505] g) were similar to the controls (3445 [610] g) as were the gestational ages (39.4 [1.7] weeks vs 39.4 [1.9] weeks).. The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.

Topics: 1-Naphthylamine; Abnormalities, Drug-Induced; Adult; Antidepressive Agents; Cohort Studies; Female; Fluvoxamine; Humans; Infant, Newborn; Paroxetine; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, First; Prospective Studies; Selective Serotonin Reuptake Inhibitors; Sertraline