CARBAMAZEPINE

This section is designed to inform professionals.

(Consumers, see Fact Sheet on Carbamazepine) 

Available as Tegretol.

Carbamazepine is an anticonvulsant which is also a mood stabiliser, used in the treatment of Bipolar Affective Disorder.

Use in Pregnancy

Category D

• Carbamazepine is associated with a higher rate of congenital abnormalities, including neural tube defects (0.5% to 1% of women treated with the drug compared to a rate of 0.1% in the general population), facial anomalies (for example, malformed ears and a high palate cleft abnormalities), gastrointestinal tract problems and cardiac abnormalities
• Other abnormalities associated with carbamazepine include fingernail hypoplasia and developmental delay.
• The overall rate for major malformations associated with carbamazepine is around 2.2%.
• Carbamazepine is associated with reductions in birth weight and a reduction in the baby’s mean head circumference.
• In the neonate there have been rare reports of transient liver toxicity (cholestatic hepatitis and direct hyperbilirubinemia).
• Carbamazepine can cause a transient and reversible deficiency in vitamin K-dependent clotting factors in the neonate that may lead to intracerebral haemorrhage. This effect can be minimized by prescribing 10 to 20 mg of vitamin K orally at 36 weeks of gestation until delivery.

Use in Lactation

Category L2

• Carbamazepine is currently accepted as being generally compatible with breastfeeding.
• Concentrations of carbamazepine in breast milk are detectable but low.
• The relative infant dose has been calculated to be around 4%. Infants should be monitored for any sedative effects.
• Most infants have had no adverse reactions, but sedation, poor sucking, withdrawal reactions and 3 cases of hepatic dysfunction have been reported.

Conclusions

In light of the above mentioned risks:

• When planning a pregnancy, women taking carbamazepine careful consideration should be given to stopping the medication.
• Carbamazepine should not be routinely prescribed for women who are pregnant because of the lack of evidence of efficacy and the risk of neural tube defects in the foetus.
• If appropriate an alternative drug could be considered
• If a woman taking carbamazepine has an unplanned pregnancy: Confirm the pregnancy as quickly as possible.
• If a woman continues taking carbamazepine throughout the pregnancy, then it is important to institute additional monitoring of the woman and the foetus (inform the professional doing morphology scan).
• After delivery, a full paediatric assessment of the newborn infant is recommended. The infant should be monitored in the first few weeks after delivery for adverse drug effects, drug toxicity or withdrawal (for example, floppy baby syndrome, jaundice, irritability, constant crying, shivering, tremor, restlessness, increased tone, feeding and sleeping difficulties and, rarely, seizures)

References

(1). Kimberly A Yonkers, Katherine L Wisner, Zachary Stowe, Ellen Leibenluft, et al. (2004) Management of Bipolar Disorder during Pregnancy and the Postpartum Period. The American Journal of Psychiatry., 161 (4): 608-13

(2). Licht RW, Vestergaard P, Kessing LV, Larsen JK, Thomsen PH. (2003). Psychopharmacological treatment with lithium and antiepileptic drugs: suggested guidelines from the Danish Psychiatric Association and the Child and Adolescent Psychiatric Association in Denmark. Acta Psychiatr Scand, 108 (Suppl. 419): 1–22

(3). Gideon Koren , M.D., Anne Pastuszak , M.SC, and Shinya Ito , M.D. (1998) Drugs in Pregnancy. The New England Journal of Medicine: Review Article: Volume 338 Number 16 1129- 1137.

(4). Morrow, J., Russell, A., Guthrie, E., et al. (2006) Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register. Journal of Neurology, Neurosurgery and Psychiatry, 77, 193–198.

(5). Altshuler, L. L., Cohen, L., Szuba, M. P., et al. (1996) Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. The American Journal of Psychiatry, 153, 592–606.

(6). Matalon, S., Schechtman, S., Goldzweig, G., et al. (2002) The teratogenic effect of carbamazepine: a meta-analysis of 1255 exposures. Reproductive Toxicology, 16: 9–17.

(7). Bar-Oz, B., Nulman, I., Koren, G., et al. (2000) Anticonvulsants and breast feeding: a critical review. Paediatric Drugs, 2, 113–126.

(8). Cohen, L. S., Sichel, D. A., Robertson, L. M., et al. (1995) Postpartum prophylaxis for women with bipolar disorder. The American Journal of Psychiatry, 152, 1641–1645.

(9). Holmes, L. B., Harvey, E. A., Coull, B. A., et al. (2001) The teratogenicity of anticonvulsant drugs. The New England Journal of Medicine, 344, 1132–1138.

(10). Lumley, J., Watson, L., Watson, M., et al. (2001) Periconceptional supplementation with folate and/or multivitamins for preventing neural tube defects. Cochrane Database of Systematic Reviews, 2.

(11). Artama, M., Auvinen, A., Raudaskoski, T. et al. (2005) Antiepileptic drug use of women with epilepsy and congenital malformations in offspring. Neurology, 64, 1874–1878.

(12)Adab, N., Tudur, Smith C., Vinten, J., et al. (2004a) Common antiepileptic drugs in pregnancy in women with epilepsy. Cochrane Database of Systematic Reviews, 3. Art No: DOI: 10.1002/14651858.CD004848

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