Antipsychotic Medication During Pregnancy Does Affect Babies

A 7-year study of women who take antipsychotic medication while pregnant, proves it can affect babies.

The observational study, published in the journal PLOS ONE, reveals that whilst most women gave birth to healthy babies, the use of mood stabilisers or higher doses of antipsychotics during pregnancy increased the need for special care after birth with 43% of babies placed in a Special Care Nursery (SCN) or a Neonatal Intensive Care Unit (NICU) - almost 3 times the national rate in Australia.

As well as an increased likelihood of the need for intensive care, the study showed that antipsychotic drugs affects babies in other ways, with 18% being born prematurely, 37% showed signs of respiratory distress, and 15% developed withdrawal symptoms.

Jayashri Kulkarni, MD, Monash Alfred Psychiatry Research Centre (MAPrc), Monash University, Melbourne, Australia, said the study highlights the need for clearer health guidelines when antipsychotic drugs are taken during pregnancy.

“There’s been little research on antipsychotic medication during pregnancy and if it affects babies,” he said. “The lack of data has made it very difficult for clinicians to say anything conclusively on how safe it is for babies. This new research confirms that most babies are born healthy, but many experience neonatal problems such as respiratory distress.”

With no existing data to draw on, MAPrc established the world-first National Register of Antipsychotic Medications in Pregnancy (NRAMP) in 2005. Women who were pregnant and taking antipsychotic medication were recruited from around Australia through clinical networks in each state and territory. In all 147 women were interviewed every 6 weeks during pregnancy and then followed until their babies were aged 1 year.

The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.

Antipsychotic drugs are used to treat symptoms of psychiatric disorders, such as bipolar disorder and schizophrenia.

The new labeling standards are for older antipsychotic drugs as well as newer ones. The FDA says its labeling change is intended to address the potential risk for abnormal muscle movements, called extrapyramidal signs (EPS), and withdrawal symptoms in newborns whose mothers were treated with antipsychotic drugs in the third trimester of pregnancy.

The FDA says the labeling change affects these antipsychotic drugs:

Abilify
Clozaril
FazaClo
Fanapt
Geodon
Haldol