Tuesday, June 07, 2011

Georgia June 7, 2011 - SSRI/Zoloft and birth defect information and update

ZoloftImage via Wikipedia
An interesting find - a published report that expands on yesterday's blog post: 

"Over the last 5 years, several studies analyzing the reproductive safety of the selective serotonin reuptake inhibitors (SSRIs), individually and as a group, have been published in the United States and elsewhere. Earlier studies that failed to show an association between first-trimester exposure to SSRIs and an overall increased risk of major congenital malformations were typically small cohort studies; subsequent meta-analyses of the available cohort studies have also failed to show an increased risk, which has been reassuring.

The cohort study, which prospectively follows both exposed and unexposed people longitudinally, is the gold standard for evaluating the teratogenic potential of drugs. However, such a study is limited by the difficulty in enrolling enough exposed subjects to demonstrate a statistically significant difference between the two groups (which is particularly true for relatively rare outcomes that can easily be missed).

Recently, several large case-control studies have been published that questioned the safety of SSRIs with respect to teratogenic risk. Case-control studies identify cases of an outcome of interest, such as a certain birth defect, and analyze case and control groups of patients to determine if an association exists between various exposures and the outcome. Such studies have included an analysis of records from a large managed care organization, which found an increased risk of heart defects in the babies of women who were prescribed paroxetine (Paxil) during pregnancy, compared with the babies of women prescribed other antidepressants during pregnancy. "

Link here