Fran Lowry

June 24, 2014

HOLLYWOOD, Florida — An evaluation of women exposed to a range of atypical antipsychotic medications during pregnancy has found that the risk for major malformations in their offspring was very low and virtually identical with that of women who were not exposed to these medications.

The results of the evaluation, conducted by the National Pregnancy Registry for Atypical Antipsychotics at Massachusetts General Hospital in Boston, are preliminary but important, Lee S. Cohen, MD, director, Center for Women's Mental Health at Massachusetts General and professor of psychiatry at Harvard Medical School, Boston, told Medscape Medical News.

"Bipolar women who are either planning pregnancy or who are pregnant frequently use atypical antipsychotics, and up until very recently, we've had very sparse data on the reproductive safety of these drugs," Dr. Cohen said here at the American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting.

"These are really the first prospective data that have systematically followed these women who take this class of medicines during pregnancy, and importantly, there doesn't appear to be a major teratogenic signal for this class of molecules compared to, for example, sodium valproate, which has a 10% risk of neural tube defects," he said.

Dr. Cohen presented data obtained from 211 women exposed to an atypical antipsychotic in the first trimester (mean age, 32 years; 71% married; 91% white) and 79 women who had bipolar disorder but who were not taking atypical antipsychotics (mean age, 33 years; 90% married; 97% white).

Dr. Lee Cohen

All medical records, including obstetric, labor and delivery, and pediatric (from birth to 6 months), were obtained, and cases of malformations were reviewed by a dysmorphologist.

In the exposed group of 200 live births, there were 3 major malformations (risk, 1.5%; 95% confidence interval [CI], 0.31% - 4.30%).

In the unexposed group, comprising 84 live births, there was 1 major malformation (risk, 1.2%; 95% CI, 0.03% - 6.53%).

"The confidence interval is still pretty big, so we are going to look to narrow that down so that we can be even more confident about that estimate," Dr. Cohen noted. "But we met with our scientific advisory board just before the ASCP meeting, and the consensus was that, since patients know so little about the reproductive safety of these medicines, even with relatively small numbers, we should report our findings."

Dr. Cohen stressed that the Registry has been very systematic in its approach.

"We have looked at all of the medical records and had a dysmorphologist adjudicate the outcome to make sure that a malformation is really a malformation," he said. "I think that patients can be at least moderately reassured that these drugs are not major teratogens. Our hope is, as we grow the sample, that we will be able to refine the risk estimate and be able to tell women more definitively about the teratogenicity both of the medicines as a class but also about the individual molecules."

A Heartening Report

Medscape Medical News invited Holly A. Swartz, MD, professor of psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, to comment on the Registry results.

Dr. Holly Swartz

"Thanks to Cohen and colleagues, we now have a better estimate of risk of atypical antipsychotics in pregnancy, and, at least when considering the risk of major malformations, that risk appears to be quite low," Dr. Swartz, who was not part of the study, said.

"Although this is an interim analysis and additional information will emerge as the investigators continue to enroll pregnant women in the Registry, this preliminary report is heartening news for both patients and providers," she said.

The Registry was established in 2008 and is ongoing. Its Web site is available at, and its toll-free telephone number is 1-866-961-2388.

The Registry is funded by Pfizer, AstraZeneca, Bristol-Myers Squibb, Sunovion, and Ortho-McNeil Janssen. Dr. Cohen reports financial relationships with AstraZeneca, Bristol-Myers Squibb, Cephalon Inc, GlaxoSmithKline, the National Institute of Mental Health, the National Institute on Aging, Noven Pharmaceuticals, Ortho-McNeil Janssen, PamLab LLC, and Sunovion Pharmaceuticals Inc. Dr. Swartz reports no relevant financial relationships.

American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting. Abstract 79. Presented June 17, 2014.


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