What considerations exist regarding the safety of using aripiprazole (Abilify) during pregnancy? If the medication is withheld and the patient becomes psychotic and injures herself, the fetus or others, what are the legal ramifications for the clinician?

Similarly, what liability exists if the medication is provided and the child is born with neural tube defects? — Timothy Coogan, PA-C, Carterville, Ill.

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Aripiprazole, used to treat schizophrenia, bipolar disorder and refractory depression, is a Pregnancy Risk Factor C drug, as it has been demonstrated to cause developmental toxicity and teratogenic effects in animal models. Newborns who are exposed to antipsychotics in utero during the third trimester may experience withdrawal symptoms (e.g., feeding difficulties, agitation, somnolence, tremor, respiratory depression) as well as extrapyramidal symptoms. Like all Pregnancy Risk Factor C drugs, aripiprazole should be used only if the potential benefit outweighs the potential risks to the fetus.

Treating psychiatric illness in a pregnant woman is a balancing act. The clinician must maximize the patient’s psychological well-being while minimizing any risks to the health of her child associated with psychotropic medications. Unless a woman has been determined unfit to make decisions for herself, the provider is obligated to discuss the risks and benefits of using a drug like aripiprazole during pregnancy and then let the patient make the final decision.

Thorough documentation of this conversation, as well as ongoing monitoring and reassessment, is required to protect against future litigation if the patient were to decompensate while off medication or the newborn were determined to have a health issue caused by exposure to a prescribed medication.

In all cases involving a pregnant woman with a psychiatric illness, a mental-health professional must be involved. Such a patient is vulnerable due to hormonal changes and the profound stressors of becoming a mother. — Mary Newberry, CNM, MSN (168-2)

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