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CHAPTER 8

Psychotropic drugs in
pregnancy
Neelam Sisodia

Introduction
Women taking psychotropic drugs in pregnancy fall into two
groups: those who are actively being treated for a pre-existing psy-
chiatric disorder and those who develop symptoms of psychiatric
disorder during the course of their pregnancy. Of the latter group,
some will have a history of psychiatric disorder, and their symp-
toms signify relapse of the pre-existing condition and the rest will
be experiencing an illness for the first time.
The prevalence of psychiatric disorder during pregnancy is the
same as in non-childbearing women of the same age. Between
15 and 20% of all pregnant women will have a mental health
problem [1], ranging from mild to moderate illnesses such as gen-
eralised anxiety, mild depression, obsessional compulsive disorder
and anxiety with panic/phobic symptoms to severe illnesses such
as moderate to severe depression, bipolar affective disorder and
schizophrenia.
The National Institute for Health and Clinical Excellence (NICE)
guideline on antenatal and postnatal mental health [2] recom-
mends that wherever possible, psychosocial interventions and
psychological therapies (supportive psychotherapy, cognitive be-
havioural therapy and interpersonal therapy) should be first-line
treatment for mild to moderate conditions. The threshold for using
psychotropic medication should be relatively high and it should be
prescribed only if a psychological approach alone does not alleviate
symptoms.

Prescribing in Pregnancy, 4th edition. Edited by Peter Rubin and Margaret Ramsay,

c 2008 Blackwell Publishing, ISBN: 978-1-4051-4712-5.

114
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Psychotropic drugs in pregnancy 115

Severe illnesses, in which psychotic symptoms may play a part,

are more likely to severely disrupt a woman’s capacity to care for
herself during pregnancy and her baby after delivery, if untreated.
Whilst psychological approaches continue to play a positive role
in treatment of these conditions, medication plays a more impor-
tant role than in minor disorders, and the threshold for its use is
lower. As all women of childbearing age may potentially become
pregnant, these women should, as part of their treatment plan,
be informed of the importance of using adequate contraception to
avoid pregnancy whilst taking drugs that may potentially harm the
fetus, at the same time also being given information about the po-
tential adverse effects on the fetus/newborn of untreated maternal
psychiatric disorder. Wherever possible, these women should be
helped to plan pregnancy during a period of remission in illness, so
that they are able to conceive free of psychotropic medication. Ide-
ally they should be managed without psychotropic medication for
the whole of the first trimester. If this is not possible, then the aim
should be to use the lowest dose of medication that gives adequate
symptom control.
The aim of initiating or continuing treatment of significant and
enduring mental illnesses with psychotropic medication during
pregnancy is to alleviate suffering during this time but also to
prevent deterioration/relapse postpartum. A detailed discussion of
psychiatric disorder in pregnancy and postpartum is beyond the
scope of this chapter. However, it should be noted that despite the
recommendations and findings of the previous enquiry, the last
Confidential Enquiry into Maternal and Child Health [3] found
that psychiatric causes of death are the second leading indirect
cause of maternal death in the UK. If all maternal deaths, includ-
ing those ascertained by the Office of National Statistics Linkage
Study are included, then suicide emerges as the leading cause of
maternal death, accounting for 15%, and psychiatric conditions
contribute to 25% of all maternal deaths.
Every effort should therefore be made during the early antenatal
period to identify women at significant risk of developing a serious
psychiatric disorder during pregnancy or postpartum [4], because
of a pre-existing condition, new onset illness or a strong family his-
tory of serious illness. Care can then be coordinated appropriately
between primary care medical and midwifery practitioners and
secondary level general adult psychiatric and obstetric services, li-
aising wherever possible with subspecialists in perinatal psychiatry,
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116 Chapter 8

in case of need for specialist advice about medication, community

outreach services or inpatient admission to a psychiatric Mother
and Baby facility [5].
Whilst the ideal is that women should plan conception at a time
when they are psychologically well and not taking psychotropic
medication, in reality approximately 50% of pregnancies are un-
planned at the point of conception. Approximately 33% [6,7] of
women have been shown to be taking prescribed medication dur-
ing the first trimester of pregnancy and a significant proportion of
these are taking psychotropic preparations. The natural inclination
of most women in this day and age is to discontinue treatment im-
mediately on discovering a pregnancy, for fear of the adverse con-
sequences of medication on the developing fetus. However, doc-
tors and other health professionals caring for these women should
advise caution in discontinuing medication immediately.
Women suffering from a mild to moderate psychiatric disorder
who become pregnant whilst taking antidepressant preparations
prescribed in primary care should be advised to withdraw from
medication gradually, as abrupt discontinuation of treatment may
cause unpleasant withdrawal symptoms, adding to any distress and
anxiety about fetal exposure to a potential teratogen.
In the case of women receiving treatment for a severe psychi-
atric disorder, a thorough evaluation needs to be made of the risks
versus the benefits. There is potential risk to the fetus of adverse
effects of psychotropic medication at various stages throughout
pregnancy, and not just at the stage of organogenesis, which has
usually been completed by the time an accidental pregnancy is
discovered. There is also risk to the fetus, however, if the mother
has a relapse of a serious mental illness that compromises obstetric
and psychiatric care and the safety of mother and fetus. If this is
a significant risk, then it will be of greater benefit for a woman to
continue treatment, even if the psychotropic preparation has to be
changed to allow for maximal safety in pregnancy. A woman con-
ceiving accidentally whilst taking psychotropic medication with
potential for causing harm to the fetus should have early access to
detailed ultrasound scanning to determine the effects of exposure
so that a wanted pregnancy is not unnecessarily terminated.
As virtually all psychotropic drugs cross the placenta, any such
preparation administered to a pregnant woman will reach the em-
bryo and fetus. The timing of exposure to psychotropic drugs is
of particular importance to the development of the central ner-
vous and cardiovascular systems (development of central nervous
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Psychotropic drugs in pregnancy 117

system begins between day 16 and 18 and the neural tube closes
by day 30, two weeks after a missed period; the various struc-
tures within the heart are formed between day 22 and 35, five
weeks after the last period). As the central nervous system contin-
ues to develop throughout fetal life and early infancy, its structural
and functional development remains vulnerable to adverse effects
from psychotropic medication (and any other potentially noxious
substances) until the end of pregnancy and beyond [8–10].

General Principles
r Psychosocial interventions and psychological therapies should be
the first-line approach to mild to moderate (non-psychotic)
psychiatric disorder.
r Severe psychiatric disorders, especially those accompanied by
psychotic symptoms, require robust management as the
consequences of untreated severe psychiatric disorder have great
adverse consequences for mother and fetus/infant.
r If medication is felt to be necessary in addition to psychological
treatment, involve the pregnant woman in the discussion to treat.
r The evidence base is changing continuously. In general, there is
much more information available about older preparations, both in
terms of potential adverse effects and benefits, and so it is best to
avoid newer drugs.
r Physiological and pharmacokinetics changes occurring in pregnancy
affect drug metabolism and therefore the doses of medication may
need to be adjusted.
r Use the lowest effective dose, dividing it through the day if
practicable with patient compliance.
r Avoid using more than one preparation wherever possible.
r Consider tapering the doses of medication towards the end of
pregnancy, discontinuing wherever possible (i.e., as long as the risk
of deterioration in the pregnant woman’s mental state is not
greater than the risk of adverse effects in the neonate) by 36–38 wk
of gestation.

Tricyclic antidepressants
Imipramine is the prototype tricyclic antidepressant (TCA). Other
drugs in this group include amitriptyline, clomipramine, do-
sulepin, dothiepin, lofepramine, trimipramine, desipramine and
nortriptyline.
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118 Chapter 8

TCAs have been in use for over 40 years. There is no evidence

of an association between treatment with TCAs and an increased
incidence of birth defects or other adverse pregnancy outcome (al-
though a few case reports exist from the 1970s to 1980s, associating
tricyclic antidepressants with congenital limb and heart malforma-
tions, polydactyly and hypospadias) [11]. Care must still be taken
towards the end of pregnancy, however, as short-lived neonatal
withdrawal symptoms such as jitteriness, hyperexcitability, my-
oclonus, convulsions and sucking problems have been reported
very occasionally, particularly in premature or small-for-dates in-
fants. To date, there is no indication that use of TCAs in pregnancy
causes adverse effects on children in terms of neurodevelopment
such as global IQ, language and behaviour (in contrast to evidence
available linking untreated severe depression in the mother with
poor cognitive development and behavioural disorder in children,
persistent to the age of 11 yr, especially in male children).
TCAs have fallen out of favour in recent years, both in pri-
mary care and general adult psychiatry because of the potential
for acute poisoning (especially cardiotoxicity) when used to self-
harm and for possible intolerance of anticholinergic side effects.
However, if a thorough assessment of potential for self-harm is
undertaken, medication supplied in small quantities and the dose
titrated slowly, there is no reason why TCAs should not be used
where significant and disabling depressive symptoms exist.
Imipramine and amitriptyline are in fact at present considered
to be the drugs of choice when treating moderate to severe de-
pression during pregnancy [12] and can be used to control se-
vere and disabling symptoms of anxiety and panic that have not
been ameliorated by psychological interventions. TCAs also have
the advantage of being excreted in low concentrations in breast
milk and there is no evidence to suggest that they cause harm to
the neonate/infant. Treatment with TCAs can therefore be rein-
stated following delivery in breastfeeding mothers.

Selective serotonin/noradrenaline reuptake

inhibitor antidepressants
The use of selective serotonin reuptake inhibitor antidepressants
(SSRIs) such as citalopram, fluoxetine, fluvoxamine, paroxetine
and sertraline has increased over the last decade, especially as first-
line drug treatment for mild to moderate depression. It has been
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Psychotropic drugs in pregnancy 119

much emphasised that SSRIs are better tolerated than TCAs and
are safer in overdose.
Previously considered to be relatively safe in pregnancy and
breastfeeding, the SSRIs are an example of how the evidence
base may change over time for new drugs. In recent years there
have been a number of studies and case reports associating SSRIs
and venlafaxine with a variety of neonatal complications such as
prematurity, low birth weight, neonatal respiratory and neurobe-
havioural difficulties and increased admission to neonatal units.
Also, there has been an association with higher incidence of three
or more minor congenital anomalies and neonatal withdrawal
symptoms with the use of fluoxetine. The likelihood of persis-
tent pulmonary hypertension of the newborn in infants exposed
to SSRIs in late pregnancy (after 20 wk of gestation) is now thought
to be increased up to sixfold [13]. Paroxetine has been associated
with ventricular septal defects and atrial septal defects [14], with
the risk being increased approximately twofold compared to that
in the general population. It remains to be seen whether this is a
class effect of SSRIs or is specific to paroxetine, but at present the
NICE guideline on antenatal and postnatal mental health does not
recommend paroxetine in pregnancy.
There is also increasing evidence that SSRIs and venlafaxine can
be associated with troublesome neonatal withdrawal symptoms
[15], noted to be most severe with paroxetine. Though SSRIs are
not absolutely contraindicated in pregnancy, exposed neonates
may need careful monitoring in a neonatal unit as the prob-
lems (abnormal movements, hypo/hypertonia, insomnia and dys-
pnoea) can persist for up to 5 days.
SSRIs have been associated with bleeding disorders in adults, and
there are case reports involving newborns. Infants exposed to flu-
oxetine prenatally may have an increased haemorrhagic tendency.
SSRIs continue to be used at present in breastfeeding women but
some preparations such as fluoxetine and citalopram have been re-
ported to cause irritability and poor-feeding in infants, especially
those who are premature or have low birth weight. Sertraline is at
present associated with least problems in breastfeeding.

Key point
r Imipramine and amitriptyline should be considered as first-line
choice when antidepressants are required in pregnancy
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120 Chapter 8

Mood-stabilising drugs
Mood-stabilising drugs such as lithium and the anti-epileptic drugs
carbamazepine, sodium valproate and lamotrigine may be used
by psychiatrists in the treatment of acute mania, as maintenance
treatment for bipolar affective disorder and as augmentation in
the treatment of chronic resistant depression. All mood-stabilising
drugs are potentially teratogenic and fetotoxic, and the adverse
effects of anti-epileptic drugs are as applicable when used in psy-
chiatric disorder as they are when used in women with epilepsy.
Women with bipolar affective disorder particularly are likely to
use a mood-stabiliser preparation for a substantial proportion of
their reproductive life. It is therefore important that they are made
aware of the risks involved in childbearing, both from the treat-
ments used and from their discontinuation. The NICE guideline
on antenatal and postnatal mental health recommends that if a
woman with bipolar affective disorder is planning pregnancy or
is already pregnant, a low dose of an antipsychotic drug is prefer-
able to a mood-stabilising agent both for the acute treatment of
mania and as prophylaxis in those whose mental state is stable.
Anti-epileptic drugs are dealt with in Chapter 9.

Lithium
Lithium has long been known to be associated with congenital
malformations of the heart, in particular Ebstein’s anomaly, in-
volving abnormalities of the tricuspid valve. However, in recent
years, it has been established that the risk of Ebstein’s anomaly
in exposed pregnancies is not as high as previously estimated. The
current information available suggests that the increased incidence
of Ebstein’s anomaly is between 1:1000 and 1:2000, against a back-
ground incidence of 1:200,000. Although the estimated risk of Eb-
stein’s anomaly in lithium-exposed infants is 10–20 times higher
than expected, the absolute risk is small (0.05–1.00%). Analysis of
combined data from several studies indicates that the overall risk
of congenital heart disease varies from 0.9 to 12.0% in lithium-
exposed pregnancies compared with 0.5–1.0% in the general pop-
ulation [16].
Other risks associated with lithium have not been quantified,
but there have been case reports of polyhydramnios after fetal
polyuria, neonatal diabetes insipidus, arrhythmias, jaundice and
hypothyroidism. Because of rapidly changing maternal plasma
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Psychotropic drugs in pregnancy 121

volume around the time of delivery, serum lithium levels may

increase markedly, causing both maternal and neonatal toxicity. A
‘floppy infant’ syndrome has been described in this context, char-
acterised by lethargy, hypotonia, cyanosis, tachypnoea, tachycar-
dia and poor sucking.
Women accidentally conceiving on lithium should not abruptly
discontinue treatment as there is a significant risk of relapse of their
illness. An early, detailed ultrasound scan will clarify whether or
not the exposed fetus has a congenital heart defect, allowing the
pregnant woman to make an informed decision about continuing
pregnancy.
The various sources reviewed [17–19] suggest that lithium is
the drug of choice when a mood stabiliser is required in preg-
nancy. However, for many women it may not be acceptable that
in addition to the possibility of congenital cardiac malformations
from exposure in early pregnancy, there may be fetotoxic effects
with continued lithium use in later pregnancy. These individuals
may choose therefore not to use lithium and instead be monitored
closely for early signs of relapse, commencing a small dose of a typ-
ical antipsychotic such as haloperidol or trifluoperazine as soon as
necessary.
Whether lithium is used in pregnancy will very much depend on
a case-by-case consideration of the risks and benefits, and any par-
ticular woman’s past history of remission/relapse and response to
treatment. The woman should be closely involved in the decision
made.

Key points
Lithium use in pregnancy
r The pregnancy should be confirmed as early as possible and an
ultrasound scan be arranged to establish gestation.
r An urgent referral to a specialist in fetomaternal medicine should
be made.
r Lithium should not be stopped abruptly because of high risk of
relapse.
r If a woman has been previously well for 2 yr or more, lithium may
be slowly withdrawn during pregnancy by 200 mg every 4 wk.
r If the woman is judged to be at high risk of relapse if the lithium is
withdrawn, the continuation of lithium in pregnancy may be
necessary. Lithium levels should be monitored monthly until 28 wk
of gestation and weekly thereafter.
(Continued )
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122 Chapter 8

(Continued )
r Urea and electrolytes and thyroid function should be regularly
monitored.
r A further detailed ultrasound scan will be necessary to exclude
major congenital cardiac abnormalities even if the lithium has been
discontinued shortly before or after conception.
r Lithium should be tapered and withdrawn by 38 wk of gestation
wherever clinically possible.
r If for any reason, for example, deterioration in a woman’s mental
state or preterm delivery, a woman is still taking lithium at the
onset of labour, lithium levels will need to be monitored during
labour and in the immediate postpartum period because of the
dangers of a sudden rise in maternal serum levels.
r Lithium should be reinstated at 400 mg daily on day 1 postpartum,
gradually increasing to the pre-pregnancy dose over 14 days, with
initial weekly monitoring of serum levels whilst ensuring adequate
hydration.
r Lithium is excreted in significant concentrations in breast milk and
therefore not recommended in breastfeeding mothers (an
antipsychotic drug may be offered instead).

Antipsychotic drugs
Antipsychotic drugs are used in the management of acute and
chronic psychiatric disorders such as bipolar affective disorder
(depressive psychosis, hypomania, mania) and schizophrenia and
schizophrenia-like illnesses. Individuals in remission may con-
tinue to take oral or depot preparations of antipsychotic drugs.
Though some of the older ‘typical’ antipsychotic drugs, which
work by blocking dopamine receptors, could potentially reduce
fertility by increasing serum prolactin levels, the newer ‘atypical’
antipsychotic drugs do not tend to have this effect (risperidone and
amisulpiride excepted). Women taking antipsychotic preparations
may therefore become pregnant and may wish to continue with
pregnancy. The adverse effects of an acute or chronic psychotic
illness in the mother will generally outweigh the risks to the fetus
of antipsychotic medication and it is important to treat psychotic
illnesses robustly.

Typical antipsychotic drugs

Data on the use of phenothiazines (chlorpromazine, trifluop-
erazine and fluphenazine) in pregnancy is based on studies of
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Psychotropic drugs in pregnancy 123

hyperemesis gravidarum. As smaller doses of medication are used

for this condition than in psychotic illnesses, this should be borne
in mind when assessing the risks versus the benefits. There have
been case reports of congenital malformations such as micro-
cephaly, syndactyly and cardiac defects associated with phenoth-
iazine use, but larger studies have failed to demonstrate a signif-
icant risk. There is little evidence of teratogenicity linked to the
use of haloperidol, a typical antipsychotic of the butyrophenone
group.
In clinical practice, if a degree of sedation is required in an
acute psychotic illness, then chlorpromazine can be used in divided
doses. Trifluoperazine and haloperidol are the drugs of choice oth-
erwise. It is best practice to prescribe antipsychotics as oral prepa-
rations in pregnancy to allow greater flexibility in dose adjustment.
The NICE guideline on antenatal and postnatal mental health does
not recommend the routine use of depot antipsychotic prepara-
tions in pregnancy as extrapyramidal side effects can occur in the
neonate/infant several months after administration. Fluphenazine
is in any case the only antipsychotic preparation available as depot
in the UK for which data on use during pregnancy is available.
Phenothiazines and haloperidol may cause withdrawal symp-
toms or transient extrapyramidal symptoms in the neonate and
therefore wherever possible, treatment should be withdrawn by
36–38 weeks of gestation.

Atypical antipsychotic drugs

The newer ‘atypical’ antipsychotic drugs have been used with in-
creasing frequency over the last decade as they are said to be bet-
ter tolerated in terms of sedation and extrapyramidal side effects.
As dopamine receptor blockade is weaker in this group of drugs,
prolactin levels tend not to be raised and therefore fertility is not
decreased. Pregnancy may occur at times of changing over from a
typical to an atypical antipsychotic preparation.
The database for the use and effects of atypical antipsychotic
drugs is small at present. A number of case reports exist, describ-
ing the diverse outcomes of pregnancies exposed to clozapine.
These include maternal hyperglycaemia and gestational diabetes
as well as fetal and neonatal problems (floppy infant syndrome,
seizures and unspecified malformations). Clozapine cannot be rec-
ommended in pregnancy at present, associated as it is with agran-
ulocytosis in adult patients. Case reports on the use of olanzapine
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124 Chapter 8

in pregnancy do not at present link it with any specific congenital

abnormality, but gestational diabetes, fetal macrosomia, neonatal
cardiomegaly, jaundice and convulsions have been described [20].
Little is known about the use of risperidone and quetiapine in
pregnancy at present.

Key points
r The antipsychotics of choice in pregnancy are trifluoperazine and
haloperidol.
r Use oral preparations, in the lowest dose possible (this will also
reduce the risk of extrapyramidal side effects as antimuscarinic
drugs are not recommended in pregnancy).
r Taper the dose and discontinue treatment between 36 and 38 wk of
gestation wherever clinically possible.
r Observe neonates for adverse effects.
r Trifluoperazine and haloperidol may be used in breastfeeding.

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