Study Finds No Link Between Antipsychotics and Birth Defects Following Pregnancy Use

Although concerns persist about a potential link between antipsychotic medications and birth defects, researchers indicate that they have failed to find any link between use of the drugs during pregnancy and the rate of problems among children born to those mothers. 

In a study published this week in the medical journal JAMA Psychiatry, researchers from Harvard Medical School and Brigham and Women’s Hospital say that the rate of children born with birth defects was not statistically different between women who took antipsychotics during pregnancy and those who did not, with potentially the exception of the drug Risperdal.

Researchers noted that over the past decade, the use of antipsychotics (APs), such as Seroquel, Geodon, Zyprexa, Risperdal and Abilify, during pregnancy has doubled. However, there is little data available on the risk that these drugs could cause birth defects when taken during pregnancy.

The study looked at data on more than 1.3 million pregnant Medicaid recipients from January 1, 2000, through December 31, 2010. They looked for pregnant women who used antipsychotics during the first trimester of pregnancy.

According to their findings, just under one percent of the subjects filed a prescription for either a newer, atypical antipsychotic or an older antipsychotic, with the vast majority being for one of the newer atypical antipsychotic drugs. They determined that 3.8% of women who took a typical antipsychotic gave birth to a child with birth defects, and 4.45% of women who took atypical antipsychotics had a child with birth defects. That compared to a birth defect rate of 3.27% among non-antipsychotic users; a difference the study authors deemed to be statistically insignificant.

The one standout was Risperdal (risperidone), which researchers found was associated with a 26% increased risk of overall malformations and cardiac malformations.

“Evidence from this large study suggests that use of APs early in pregnancy generally does not meaningfully increase the risk for congenital malformations overall or cardiac malformations in particular,” the researchers concluded. “The small increase in the risk for malformations observed with risperidone requires additional study.”

The findings contradict some previous studies and confirms others. However, in February 2011, the FDA issued a safety alert for Seroquel, Zyprexa, Risperdal, Geodon, Invega and Abilify, all newer antipsychotics, indicating that pregnant mothers who take these drugs may give birth to children who suffer from abnormal muscle movements, known as extrapyramidal signs (EPS) and drug withdrawal symptoms. However, the warning was for mothers who used the drugs in their third trimester.

A study by Canadian researchers published in May in The BMJ warned that the use of atypical antipsychotics led to a higher rate of adverse events during delivery.