Aripiprazole during Pregnancy

Schizophrenia is a serious mental disorder that most commonly arrives inside the 20s. The good news is there are medications that can help individuals experiencing this mental condition live a fairly normal life. One of the challenges, however is that this time of life is also the most likely for having and growing your family with children.

Aripiprazole during pregnancy is a common question for women who have been diagnosed with schizophrenia. Maintaining this normal life through medication while trying to conceive or discovering you are pregnant leaves many with questions about the wellness of the baby. Will medications that keep the mental mind in check cause any harm to the developing baby?

Brand name: Abilify

Manufacturer: Bristol-Myers Squibb

Therapeutic Effect: Abilify is indicated for:

  • The treatment of schizophrenia.
  • The acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder.
  • Use as an adjunctive therapy to either lithium or valporate for the acute treatment of manic and mixed episodes associated with bipolar I disorder.
  • Use as an adjunctive therapy to antidepressants for the treatment of for the treatment of major depressive disorder.
  • The treatment of irritability associated with autistic disorder.

Pregnancy Safety Rating: Category: C

Pregnancy Recommendation: Limited human data- Animal data suggest risk

Side Effects:

  • Frequent: (11%-5%) Weight gain, headache, insomnia, vomiting.
  • Occasional: (4%-3%) Light-headedness, nausea, akathisia, drowsiness.
  • Rare: (2% or less) Blurred vision, constipation, asthenia, (loss of energy/strength), anxiety, fever, rash, cough, rhinitis, orthostatic hypotension.

Lifespan Considerations

Pregnancy/Lactation: Unknown if drug crosses placenta. May be distributed in breast milk. Breast-feeding not recommended. Pregnancy Category C.

Pregnancy Summaries

Briggs, Freeman, & Yaffe – Only three reports have described the use of aripiprazole in human pregnancy. No developmental toxicity was observed in these cases. The animal data suggests a risk of developmental toxicity and possibly teratogenicity, but the very limited human pregnancy experience prevents a complete assessment of the embryo-fetal risk. Until such data are available, the safest course is to avoid the drug in pregnancy. However, if the mother’s condition requires treatment with aripiprazole, the lowest effective dose, avoiding the 1st trimester if possible, should be used. In addition, long-term evaluation of the infant is warranted. If aripiprazole is used in pregnancy, health care professionals are encouraged to call the toll free number (800-670-6126) for information about patient enrollment in the Motherisk study.

Physicians’ Desk Reference – There are no adequate and well-controlled studies in pregnant women. It is not known whether aripiprazole can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Aripiprazole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. For further information, please refer to the Physicians’ Desk Reference or contact your Healthcare Provider.

Reprotox Toxicology Center – In rats, aripiprazole caused diaphragmatic hernia at maternal levels 10 times the recommended human dose. There are two case reports of use in human pregnancy without adverse consequences. There are no data on human lactation. Aripiprazole, like other antipsychotics, may cause hyperprolactinemia which is associated with galactorrhea, menstrual irregularities, and infertility.

If you are pregnant and have questions related to medication use during pregnancy, the Reprotox Database is the most comprehensive resource on medication use during pregnancy.  You can subscribe for only $17.00 – Subscribe Now.

The American Pregnancy Association does not prescribe medication nor do we serve as a consult for medication use during pregnancy.  It is imperative that you discuss the use of any medication during pregnancy with your health care provider.  The purpose of this document is to provide you with information to support discussions with your health care provider.

Sources:

  1. Hudgson, Barbara and Kizior, Robert, Saunders Nursing Drug Handbook 2012, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2.
  2. Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & 3. Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.
  3. Physicians’ Desk Reference (PDR), PDR Network, LLC, Motvale, NJ 07645 ISBN: 978-1-56363-780-3
  4. Reproductive Toxicology Center, http://www.reprotox.org, agent # 4246