Review Article
Selective Serotonin Reuptake Inhibitors in Human Pregnancy: To Treat or Not to Treat?
Table 2
Shepard's amalgamation of criteria for proof of human teratogenicity (Source: shepard, 1994 [
51]) applied to SSRIs.
| Criterion | Fulfillment by SSRIs |
| (1) Proven exposure to agent at critical time(s) in prenatal development. | No |
| (2) Consistent findings by two or more epidemiologic studies of high quality: | | (a) Control of confounding factors | | (b) Sufficient numbers | | (c) Exclusion of positive or negative bias factors | No | (d) Prospective studies, if possible | | (e) Relative risk of six or more (?) | |
| (3) Careful delineation of the clinical cases. A specific defect or syndrome, if present, is very helpful | No |
| (4) Rare environmental exposure associated with rare defect | Not applicable |
| (5) Teratogenicity in experimental animals | No |
| (6) The association should make biological sense | No |
| (7) Proof in an experimental system that the agent acts in an unaltered state | Evidence of placental transfer |
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Note: items (1), (2), and (3) or (1), (3), and (4) are essential criteria. Items (5), (6), and (7) are helpful but not essential.
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