Antipsychotic Use During Pregnancy Results in High Adverse Event Rates: Study

While a new study suggests that pregnant women who take atypical antipsychotics, such as Seroquel, Zyprexa, Risperdal, Abilify or other related drugs, do not experience higher rates of certain complications, they do have a slightly higher risk of labor induction and complications that should raise some concerns. 

Canadian researchers published a study on May 13 in BMJ, which examined outcomes for women who used antipsychotics during pregnancy with non-users who had other similar risk factors. Overall, the study found that antipsychotics during pregnancy does not appear to impact rates of gestational diabetes, preterm births, hypertension and blood clot risks. However, women who took these drugs did have a higher rate of other adverse events that resulted in a need for operative vaginal delivery.

The study looked at data on women who delivered a child between 2003 and 2012 in Ontario, Canada. It compared 1,021 women who used one of the three antipsychotic drugs against 1,021 non-users with other similar risk factors.

The risk of labor induction and operative vaginal delivery was about 70% higher among women taking the antipsychotic drugs.

“Antipsychotic drug use in pregnancy had minimal evident impact on important maternal medication and short term perinatal outcomes,” the researchers determined. “However, the rate of adverse outcomes is high enough to warrant careful assessment of maternal and fetal wellbeing among women prescribed an antipsychotic drug in pregnancy.”

The study was partially inspired by a 2011 FDA drug safety communication, which warned that atypical antipsychotics taken during pregnancy may increase the risk of abnormal muscle movements and withdrawal symptoms in newborns. The FDA found a seven-fold increased risk of such events among antipsychotic users.

However, the researchers in the latest study say that when the 69 women who were part of the study are compared with women with similar confounding factors who did not take the drugs, the risk mostly disappeared, leaving only an increased risk that is non-statistically significant.

The findings conflict with those of a similarly-sized study published in March in the Journal of Clinical Psychiatry. French researchers found that expecting mothers who took antipsychotics like Risperdal and Seroquel, faced a 74% increased risk of neonatal hospitalization.

Antipsychotic Health Risks

Antipsychotics are a broad class of medication used to treat psychiatric problems such as bipolar disorder and schizophrenia, but they are also often used by doctors to treat a variety of off-label ailments that have not been approved by the FDA. The drugs are known to have the ability to cross the placenta and affect unborn children.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that was a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales at its peak. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has also been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism. AstraZeneca reached a $520 million settlement with the Department of Justice (DOJ) over off-labeling charges in 2010.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen. The atypical antipsychotic is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism.

Use of Risperdal by young boys has been linked to a risk of gynecomastia, which is a rare medical disorder where the males develop full breasts. Some boys and young men using Risperdal have experienced the development of breasts up to a D-cup, often resulting in the need for surgical removal.

In the United States, a growing number of Risperdal lawsuits are currently being pursued against the drug makers, alleging that inadequate warnings about the gynecomastia risk were provided for families and the medical community. In addition to the physical injury, the complaints often allege that the young boys who experienced breast growth face humiliation, bullying and other psychological problems as a result of Risperdal-induced gynecomastia.