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New Safety Warnings for Antipsychotic Drugs in Pregnancy

by Dr. Nithin Jayan on  December 17, 2011 at 12:44 PM Health In Focus   - G J E 4
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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. 
New Safety Warnings for Antipsychotic Drugs in Pregnancy
New Safety Warnings for Antipsychotic Drugs in Pregnancy

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.

Prescription of 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 pregnancy.

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 fetus.

It 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 same.

Reference: Labeling Guidelines for Antipsychotics During Pregnancy; Tammie Lee Demier et al; US Pharmacist; 2011

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