Antipsychotics and pregnancy.(GUEST EDITORIAL)

Data on the reproductive safety of certain psychotropics such as selective serotonin reuptake inhibitors, anti-epileptics, and some antipsychotics have increased over the last few years. But information on risks of fetal exposure to atypicals remains more sparse.

This is particularly true for the newer atypical antipsychotics--although they are increasingly being used in women of reproductive age for a range of psychiatric disorders, including schizophrenia, bipolar disorder, and depression. It is therefore critical that clinicians have good information upon which to base decisions about continuing treatment during pregnancy.

So far, few prospective studies on atypicals in pregnant women have been published. In a study comparing pregnancy outcomes in 151 subjects exposed to different atypicals--60 to olanzapine (Zyprexa), 49 to risperidone (Risperdal), 36 to quetiapine (Seroquel), and 6 to clozapine (Clozaril)--with nonexposed controls, major malformation rates were not significantly different between the two groups (J. Clin. Psychiatry 2005;66:444-9). However, this is a relatively small sample. (The other two atypicals available are aripiprazole [Abilify] and ziprasidone [Geodon].)

The other available safety data on atypical antipsychotics in pregnant women are derived mainly from case reports or small case series, which have not identified an increased risk for major malformations.

Most of the prospectively identified cases of exposure are to olanzapine (133), risperidone (over 500), and quetiapine (42), with very few to aripiprazole and clozapine, and possibly none to ziprasidone. In March, some of the first registry data on atypicals were reported at a meeting, from the Australian Pregnancy Registry. Among 38 pregnancies exposed to atypical antipsychotics, no major malformations were found.

The association of the atypicals with weight gain, diabetes, and hypertension raises another potential safety issue. Weight gain and adiposity in pregnant women also have been associated with an increased risk of neural tube defects, independent of folate status (Am. J. Psychiatry 2002;159:136-7).

As is often the case when considering the use of psychotropics during pregnancy, the specific clinical approach depends on when the patient sees the clinician.

For a patient who presents for evaluation before pregnancy on a low dose of an atypical as an adjunct to a mood stabilizer, it might make sense to switch to an antipsychotic for which more reproductive safety data are available, such as perphenazine.

Because of the absence of indicting data, we have tended to maintain patients on atypicals if they are already pregnant because of our concerns about clinical destabilization. However, we do recommend close follow-up for safety issues such as weight gain and diabetes. It is important to work with the obstetrician.

Another consideration is that some patients appear to derive particular benefit from an atypical antipsychotic.

However, the limited data that are available suggest that there does not appear to be a glaring reproductive safety signal for the atypicals. Given the prevalence of use of these medicines in psychiatry, more quality data are needed on this drug class, similar to those we have for antidepressants and antiepileptic drugs (AEDs), so that that the atypicals can be safely integrated into the treatment algorithms.

At Massachusetts General Hospital, we are establishing an atypical antipsychotic pregnancy registry that will be similar to the North American AED registry This registry, along with other global AED registries, has produced invaluable data on the reproductive safety of antiepileptics. We hope that data on atypicals will make it possible for women and their physicians to make more informed decisions about use of this drug class during pregnancy.

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Dr. Cohen directs the perinatal psychiatry program at Massachusetts General Hospital, Boston, which provides information about pregnancy and mental health at www.womensmentalhealth.org. He is a consultant to manufacturers of atypical antipsychotics.

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