Study Suggests Risperdal in Early Pregnancy Might Increase Birth Defects Risk

Published on August 26, 2016 by Sandy Liebhard

The findings of a new study suggest that babies born to women who take Risperdal during the early months of  pregnancy may be more likely to suffer from birth defects. However, other antipsychotic medications do not appear to be associated with a similar risk.

More Pregnant Women Using Antipsychotic Drugs

According to a paper published this month in JAMA: Psychiatry, the frequency of antipsychotic use during pregnancy has approximately doubled during the last decade. However, little is known about their effects on a developing fetus. To investigate the possible link between birth defects and first-trimester antipsychotic use, the authors of the report reviewed medical records on 1,341,715 women. The records were obtained from the pregnancy cohort of the Medicaid Analytic Extract database, which included data from January 1, 2000, to December 31, 2010.

The research team was able to identify 9,248 women who had filled a prescription for atypical antipsychotics, such as Risperdal, during their first trimester of pregnancy. Another 733 had filled a prescription for a typical antipsychotic during the same period.  Those subjects were matched to similar women who were not taking antipsychotics during their pregnancy.

After adjusting for other factors that might make congenital abnormalities more likely, the researchers concluded that the majority of antipsychotic medications were not associated with an increased birth defect risk. The only exception was risperidone, the active ingredient in Risperdal. The analysis suggested that pregnant women who used this medication were 26% more likely to have a baby with birth defects compared to women who did not.

The authors of the study could not explain why risperidone might increase the risk for birth defects while other antipsychotics did not.

“It definitely needs more study,” lead author Krista Huybrechts, of Brigham and Women’s Hospital and Harvard Medical School in Boston, told Reuters. “We did a lot of analyses to see if we could explain that observation and we couldn’t.”

Risperdal Gynecomastia Litigation

Risperdal is approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. The medication is currently the focus of a massive products liability litigation over its alleged association with gynecomastia, or excessive male breast development.

Just last month, a state court jury in Philadelphia, Pennsylvania, awarded $70 million to a teenager who developed female-like breasts after he began taking Risperdal in 2003. The case was the fifth gynecomastia lawsuit to go to trial in a mass tort litigation that involves more than 1,700 claims. All but one trial has concluded with a finding in favor of plaintiffs.