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Latest Research from the CWMH: More Data on the Reproductive Safety of Lurasidone and Quetiapine

The National Pregnancy Registry for Atypical Antipsychotics was created with the intention to evaluate the security of atypical antipsychotic medications taken by women while pregnant. Since its inception, we now have enrolled over 3000 women within the registry, and we now have been in a position to publish data on the reproductive safety of aripiprazole (Abilify), olanzapine (Zyprexa) and quetiapine (Seroquel). Now we now have some preliminary data on using lurasidone (Latuda) while pregnant.



The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program by which pregnant women between the ages of 18 and 45 are enrolled and interviewed while pregnant. Medical records are reviewed to substantiate the presence or absence of major malformations. 

 Of the two,293 women enrolled on the time of research, there have been 134 within the lurasidone exposure group, 264 within the quetiapine exposure group, and 886 controls. The chance of major malformations was 2.19% within the lurasidone group, 1.85% within the quetiapine group, and 1.77% within the controls. Odds ratios comparing lurasidone and quetiapine with controls were 1.24 (95% confidence interval [CI] = 0.36-4.32) and 1.04 (95% CI = 0.38-2.85), respectively. No specific patterns of malformations were observed in infants exposed to the medications. 

Reassuring Data But More Data on Lurasidone is Needed

The newer atypical or second-generation antipsychotic agents are used to treat a spectrum of psychiatric disorders, including psychotic disorders, bipolar disorder, major depression, PTSD and other anxiety disorders. Our data on the reproductive safety of those newer atypical agents is growing. 

This study provides reassuring data regarding the security of prenatal exposure to lurasidone and quetiapine in a sample of well-characterized participants followed prospectively and is consistent with previous studies assessing infants exposed to this class of medicines. Based on the findings of this study, it seems that lurasidone and quetiapine don’t look like major teratogens. No studies to date have demonstrated a rise in risk of malformations in children exposed to atypical antipsychotics.

While the preliminary data from this study is reassuring, larger numbers of participants are needed to supply more complete data regarding the reproductive safety of atypical antipsychotics as a category of medicines. These findings, taken along with other studies, suggest that prenatal exposure to atypical antipsychotics doesn’t appear to significantly increase the danger for congenital malformations, although we now have only a few documented exposures to a few of the newest atypicals, including lurasidone (Latuda), iloperidone (Fanapt), brexpiprazole (Rexulti), and cariprazine (Vraylar).

The National Pregnancy Registry for Atypical Antipsychotics continues to recruit pregnant women taking atypical antipsychotic medications. CALL TOLL-FREE to learn more 1-866-961-2388 or fill out this Patient Interest Form to be contacted by our research coordinator. All information is kept strictly confidential. Participation consists of three phone interviews.

Ruta Nonacs, MD PhD

Cohen LS, Church TR, Freeman MP, Gaccione P, Caplin PS, Kobylski LA, Arakelian M, Rossa ET, Chitayat D, Hernández-Díaz S, Viguera AC.   Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications.  J Womens Health (Larchmt). 2023 Jan 30.

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