ARIPIPRAZOLE
This section is designed to inform professionals
(Consumers, see Fact Sheet on Aripiprazole)
Available as Abilify
- Aripiprazole is a unique atypical antipsychotic quite unlike other current antipsychotics in chemical structure and pharmacological properties
- It is used to treat schizophrenia including for maintenance treatment.
- It is also used to treat episodes of mania or mixed episodes in patients with bipolar disorder but is not yet approved by Pharmac for this use, in NZ.
USE IN PREGNANCY
Category B3
- Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
- In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.
- There are no adequate and well-controlled studies of aripiprazole in pregnant women.
- As human experience is limited, administration of aripiprazole should be used in pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus.
USE IN LACTATION
Category L3
- There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed infant is possible.
- Drugs should be given only if the potential benefit justifies the potential risk to the infant.
- Patients should be advised not to breastfeed an infant while receiving aripiprazole.
- It is not known whether aripiprazole or its metabolite are excreted in human milk.
References
1. Medsafe: Information for the Health Professional.
2. Medline Plus: Trusted Health information for you.
3. Bristol- Myers Squibb (NZ) Limited: Product information Document for Abilify.
4. Drugs and Pregnancy: Pharmacy Department, The Royal Women’s Hospital, Women’s and Children’s Health, Melbourne, Australia 2001.
5. Thomas W. Hale (2004). Eleventh Edition.Medication and Mothers’ Milk.
6. Salvatore Gentile (2004): Clinical utilization of Atypical Antipsychotics in Pregnancy and Lactation.
The Annals of pharmacotherapy: vol. 38, No. 7 pp. 1265-1271.
7. Deborah Yaeger, Healey G. Smith, LoriL.Altshuler:Atypical Antipsychotics in the treatment of Schizophrenia during pregnancy and the postpartum. Am J Psychiatry 163:12, December 2006.
8. Mendhekar D, Sharma J, Srilakshami P: Use of Aripiprazole during late pregnancy in a woman with psychotic illness.
Ann Pharmacother. 2006 March; 40(3): 575.
9. Mendhekar D, Sunder KR, Andrade C: Aripiprazole use in a pregnant schizoaffective woman. Bipolar Disord. 2006 Jun: 8(3):299-300.
10. Doulgeraki G, Karadima D, Kalogiratos G et al. Pregnancy, aripiprazole, and psychotherapy (abstract).Eur Psychiatry 2007; 22(Suppl.1): S206, abstract P369- 15th Association of European Psychiatrists (AEP) congress..
11. Mervak B, Collins J, Valenstein M. Case report of aripiprazole usage during pregnancy.Arch Womens Ment Health; 2008 Jun 26.
12. Schlotterbeck P, Leube D, Kircher T, Hiemke C, Grunder G. Aripiprazole in human milk. Int. J. Neuropsychopharmacol. 2007 10:3 (433)
13. Gentile S. Infant safety with antipsychotic in breast-feeding: A systemic review.J Clin Psychiatry 2008; 69: 666-673.
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