US FDA calls for antipsychotic drug labels to reflect risk to newborns

The US Food and Drug Administration yesterday told health care professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs, due to concerns of their use by pregnant women risks side effects in newborns.

The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

According to a report in the February issue of Archives of General Psychiatry, prescriptions for these drugs significantly declined after the FDA warned that their off-label use in the treatment of dementia in older adults was linked to more deaths, and already carry a Black Box warning to this effect.