Psychoactive drug exposure during breastfeeding: a critical need for preclinical behavioral testing.

Breastfeeding women are excluded from clinical trials of psychoactive drugs because of ethical concerns. Animal testing, which often is predictive of adverse effects in humans, represents the only avenue available for assessing drug safety for human offspring exposed to drugs during lactation. I determined whether behavioral outcomes for children exposed during breastfeeding to antidepressants, anxiolytics, antipsychotics, anti-seizure medications, analgesics, sedatives, and marijuana can be predicted by rodent studies of offspring exposed to drugs during lactation. Animal data were available for only 10 of 80 CNS-active drugs canvassed. Behavioral deficits in adolescence or adulthood in rats and mice after various drug exposures during lactation included reductions in sexual behavior, increased anxiety, hyperactivity, and impaired learning and memory. Whether similar adverse effects will emerge in adulthood in children exposed to drugs during breastfeeding is unknown. Rodent research has the potential to forecast impairments in breastfed children long before information emerges from post-marketing reports and should be prioritized during preclinical drug evaluation by the FDA for new drugs and for drugs currently prescribed off-label for lactating women.