ABSTRACT
CONTEXT: 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. OBJECTIVE: To assess fetal safety and risk of fluvoxamine, paroxetine, and sertraline. DESIGN: A prospective, multicenter, controlled cohort study. SETTING: Nine Teratology Information Service centers in the United States and Canada. PATIENTS: 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. MAIN OUTCOME MEASURES: Rates of major congenital malformations. RESULTS: 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). CONCLUSION: The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.
Subject(s)
Abnormalities, Drug-Induced/etiology , Antidepressive Agents/adverse effects , Selective Serotonin Reuptake Inhibitors/adverse effects , 1-Naphthylamine/adverse effects , 1-Naphthylamine/analogs & derivatives , Adult , Antidepressive Agents/therapeutic use , Cohort Studies , Female , Fluvoxamine/adverse effects , Humans , Infant, Newborn , Paroxetine/adverse effects , Pregnancy , Pregnancy Outcome , Pregnancy Trimester, First , Prospective Studies , Selective Serotonin Reuptake Inhibitors/therapeutic use , SertralineABSTRACT
Compared to maternal exposures, little attention has been paid to the possibility of paternally induced adverse effects on fetal development. There is increasing concern, however, about the potential for male-mediated developmental toxicity brought about by exposure to teratogenic agents. This is evidenced by the number of calls regarding paternal exposures that are received by teratogen information services. In this paper, we report the experience of the state of Florida's Teratogen Information Services regarding questions asked about paternal exposures, and briefly review what is known about the risk of paternal exposure to the 10 agents which are most frequently queried.
Subject(s)
Abnormalities, Drug-Induced/etiology , Paternal Exposure/adverse effects , Abnormalities, Drug-Induced/epidemiology , Antineoplastic Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions , Environmental Pollutants/adverse effects , Female , Florida/epidemiology , Humans , Information Centers/statistics & numerical data , Male , Pesticides/adverse effectsABSTRACT
OBJECTIVE: Our purpose was to examine the potential teratogenicity of calcium channel blockers. STUDY DESIGN: Six teratogen information services prospectively collected and followed up 78 women with first-trimester exposure to calcium channel blockers. Pregnancy outcome was compared (by paired t text of chi2 analysis) with that of a control group matched for maternal age and smoking. RESULTS: There was no increase in major malformation (2/66=3.0% [calcium channel blockers] vs 0% [nonteratogenic controls], p=0.27); a fivefold increase was ruled out (baseline 2%, alpha = 0.05, beta = 0.20). The defects reported were attributable to maternal diabetes or coingestion of teratogens. The increase in preterm delivery 28% [calcium channel blockers] vs 9% [nonteratogenic controls], p=0.003), attributed to maternal disease by stepwise regression, was the most important factor responsible for the observed decrease in birth weight (mean -334 gm vs nonteratogenic controls, p=0.08). CONCLUSION: This study suggests that calcium channel blockers do not represent a major teratogenic risk.
