A new safety warning
regarding the use of antipsychotics (APs) during pregnancy has been issued by
the FDA. With this announcement, the overall safety of prescribing
antipsychotic drugs during pregnancy is under suspicion once again.
The peak age of onset of
psychiatric disorders in women occurs during the childbearing years from 20 to
40. A significant proportion of affected women are exposed to psychotropic
medication at some point during their pregnancy. Ethical complications limit
the number of studies regarding the safety of APs during pregnancy. Little is
known about the risks to the unborn when the mother is on antipsychotic drugs.
The Food and Drug
Administration (FDA) has asked health
care professionals to update the labeling for all APs. An enhanced
'pregnancy section' that provides more detailed information about the safety of
drug usage during pregnancy is to be included in the labels.
Newborns of mothers
taking antipsychotics may develop abnormal movements, called extrapyramidal symptoms (EPS).
EPS is a common side effect seen in adults on APs. The abnormal movements in
newborn are also thought to be due to a withdrawal syndrome. The
antipsychotic exposure received by the fetus while inside the mother's uterus
is lost at birth and thus may cause withdrawal syndrome. 69 cases of neonatal
EPS or withdrawal were reported in October 2008. Some newborns required
intensive care and prolonged hospitalization. Recovery following a few hours
after birth was noted in others.
antipsychotic medications has been on a rise. Depression, agitation seen with
concurrent co-morbid disorders, sleep disorders are all routine indications for
atypical antipsychotics. The FDA has consistently worked to develop and include
more comprehensive information in drug labels about the drug's effects during
Pharmacists must be
familiar with the risks and benefits of medications used to treat mental
illness in women of childbearing age. The new FDA recommendation lays
more stress on this requirement. Physicians should be fully aware of the risks
of the drugs prescribed to pregnant women. Therapeutic goals should be
discussed with the patient. Risks should always be weighed against benefits.
Pregnancy is a critical
period when the body undergoes a lot of metabolic changes that alter the way
drugs get utilized and metabolised. This means the choice of prescribed drug should
be made with utter care, considering the condition of the patient. It should be
highly customised to the bodily state of the pregnant patient.
Physicians should prescribe antipsychotics to pregnant women
only after ensuring that the benefit of medications is truly greater than the
risk. If at all
pregnant women take antipsychotic drugs, it should be only under the
supervision of a physician who can manage any potential adverse effects in the
is worth to note that the new model of mental health care delivery stresses on
the concept of community and family support to tackle psychiatric symptoms.
Institutional hospitalizations are as shortened as possible. Nondrug therapy is
considered whenever possible. When drug therapy is indicated, the prescriber
should be familiar with the risks and the patient must be educated about the
Reference: Labeling Guidelines for Antipsychotics During Pregnancy; Tammie Lee Demier
et al; US Pharmacist; 2011