Fran Lowry

June 07, 2016

SCOTTSDALE, Arizona ― The use of atypical antipsychotics during pregnancy is associated with a modest level of risk for fetal malformations, according to an analysis of information contained in a large and ever-expanding registry.

"Despite the widespread use of atypical antipsychotics in women of childbearing age, data about reproductive safety has been sparse," Lee S. Cohen, MD, from Massachusetts General Hospital, Boston, told Medscape Medical News.

"To address this knowledge gap, we formed the National Pregnancy Registry for Atypical Antipsychotics ― NPRAA ― at the Mass General in 2008, and the information it contains is telling us that there does not appear to be a major teratogenic signal with using the atypical antipsychotics during the first trimester, and there is no particular pattern of malformation using this family of compounds during pregnancy," Dr Cohen said.

The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) 2016 Annual Meeting.

"This is an extension of the work we have been doing now for several years in this registry. Its goal was to assess risk for malformations associated with the use of atypical antipsychotics during the first trimester of pregnancy and to do it in a much more rigorous fashion than could be done by using large administrative databases, where separating signals from noise is very difficult," he said.

"This does not mean that they are absolutely safe, because we continue to grow the numbers in the registry. But our confidence intervals are getting tighter and tighter, and we are becoming more confident that the risk is modest with the use of these agents, which may be reassuring for both clinicians and women trying to make risk-benefit treatment decisions about using these drugs during pregnancy," he said.

Pregnant women between the ages of 18 and 45 years are eligible to enroll in the NPRAA. Exposed women are those who have taken one or more atypical antipsychotics during pregnancy; the comparison group comprises women who have not taken this class of drug during pregnancy.

The women are prospectively followed throughout their pregnancy with three interviews conducted by phone, one at baseline or close to the time of enrollment, one at 7 months' gestation, and one 3 months post partum.

Each woman provides consent to obtain their obstetric history, newborn history, and pediatric records. Potential major malformations are identified, and relevant records are sent to a dysmorphologist who is blinded to drug exposure for adjudication.

As of December 2015, data on 351 women had been analyzed.

Of 240 live births with first-trimester exposure to atypical antipsychotics, three major malformations were confirmed.

Among 111 live births for women not receiving atypical antipsychotics during the first trimester of pregnancy, one major malformation was confirmed.

The absolute risk for major malformations was 1.3% for infants exposed to an atypical antipsychotic during the first trimester, and 0.9% for unexposed infants.

In a comparison of exposed infants to unexposed infants, the odds ratio for major malformations was 1.39 (95% confidence interval [CI], 0.14 - 13.54).

Women who are interested in enrolling in the registry are invited to telephone 1-866-961-2388 (a toll-free number) and to visit the NPRAA website, Dr Cohen said.

"The NPRAA is a wonderful contribution to public health, addressing a big, unmet need," Alan J. Gelenberg, MD, professor emeritus at the University of Arizona, Tucson, who was not involved in the research, told Medscape Medical News.

Dr Cohen has financial relationships with AstraZeneca, Bristol-Myers Squibb/Otsuka, Ortho-McNeil Janssen, Pfizer, Inc, Sunovion Pharmaceuticals, Cephalon, Inc, GlaxoSmithKline, the National Institute on Aging, the National Institutes of Health, the National Institute of Mental Health, Takeda/Lundbeck, Noven Pharmaceuticals, PamLab LLC, and JDS Therapeutics LLC. Dr Gelenberg has disclosed no relevant financial relationships.

American Society of Clinical Psychopharmacology (ASCP) 2016 Annual Meeting: Abstract 3000502, presented June 2, 2016.

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