Budesonide in Pregnancy and Breastfeeding
      
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Budesonide (Pulmicort Turbuhaler ®)

SUMMARY: Budesonide is considered to be safe for use in pregnancy. Budesonide is the drug of choice for the maintenance treatment of asthma.

Corticosteroid. Molecular weight: 430.5.
CATEGORY: B

"Budesonide produced fetal loss, decreased pup weight, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg/day in rabbits (approximately 1/3 the maximum recommended daily inhalation dose in adults on a mcg/m 2 basis) and 500 mcg/kg/day in rats (approximately 3 times the maximum recommended daily inhalation dose in adults on a mcg/m 2 basis).

No teratogenic or embryocidal effects were observed in rats when budesonide was administered by inhalation at doses up to 250 mcg/kg/day (approximately 2 times the maximum recommended daily inhalation dose in adults on a mcg/m 2 basis)" [1]

Analysis of data in the Swedish Medical Birth Registry showed no increase in the incidence of congenital defects in a population of 2014 infants whose mothers used budesonide during early pregnancy [2].

Data from the same registry compared 2,968 mothers who reported use of inhaled budesonide during early pregnancy with those reporting no asthma medication usage. The mothers who reported use of inhaled budesonide during early pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths or multiple births compared to the unexposed controls [3].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) consider beclomethasone and budesonide to be the inhaled steroids of choice for use during pregnancy [4].


BREAST FEEDING: "Corticosteroids are secreted in human milk. Because of the potential for adverse reactions in nursing infants from any corticosteroid, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Actual data for budesonide are lacking" [1].


SEARCH LITERATURE

1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2003: 638
2. Kallen B, Rydhstroem H, Aberg A. Congenital malformations after the use of inhaled budesonide in early pregnancy. Obstet Gynecol. 1999 Mar;93(3):392-5. MEDLINE
3. Norjavaara E and de Verdier MG. Normal pregnancy outcomes in a population-based study including 2,968 pregnant women exposed to budesonide.J Allergy Clin Immunol. 2003;111:736-42. MEDLINE
4. The use of newer asthma and allergy medications during pregnancy. Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE

Created: 1/10/2003
Update: 12/10/2003
Update: 6/26/2007 Mark Curran, M.D. FACOG

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