What are the guidelines for using budesonide (corticosteroid) formoterol (long-acting beta-agonist) in pregnancy?

Budesonide/Formoterol Use During Pregnancy

Budesonide/formoterol combination therapy can be safely continued during pregnancy in women who were well-controlled on this medication prior to pregnancy. 1

Safety Profile of Components

Budesonide

• Budesonide is the preferred inhaled corticosteroid (ICS) during pregnancy with the most safety data and is classified as FDA Pregnancy Category B 1
• Studies including over 6,600 infants exposed to budesonide during pregnancy show no increased risk of congenital malformations or adverse fetal outcomes 2, 3
• At usual doses, budesonide has not been associated with increased risk of major malformations, intrauterine growth restriction, preterm delivery, or low birth weight 1

Formoterol

• Limited human data exists on formoterol use during pregnancy, but animal data suggest low risk 1
• The FDA label for formoterol notes potential risks at very high doses in animal studies, but these occurred at exposures far exceeding therapeutic human doses 4
• If a woman was well-controlled on formoterol before pregnancy, it is acceptable to continue with the same medication during pregnancy 1

Recommendations for Asthma Management During Pregnancy

General Principles

• Poorly controlled asthma poses greater risks to mother and fetus than potential medication risks 1
• Maintaining good asthma control during pregnancy is critical for maternal and fetal well-being 1

Specific Recommendations for Budesonide/Formoterol

• For moderate persistent asthma, a combination of low-dose ICS and long-acting beta-agonist (LABA) is a preferred treatment option 1
• While salmeterol has historically been preferred due to longer experience during pregnancy, continuing formoterol is acceptable if the patient was previously well-controlled 1
• A comparative safety study found no statistically significant differences in low birth weight, preterm birth, or small for gestational age infants between women using formoterol versus salmeterol during pregnancy 5

Dosing Considerations

• Use the lowest effective dose necessary to maintain asthma control 1
• Regular monitoring of asthma symptoms is recommended throughout pregnancy 1
• Exacerbations during pregnancy should be managed aggressively due to potential fetal risks 1

Clinical Algorithm for Management

1. For patients already on budesonide/formoterol before pregnancy:

   • Continue the medication if asthma is well-controlled 1
   • Monitor asthma control regularly throughout pregnancy 1

2. For patients requiring initiation of therapy during pregnancy:

   • Consider budesonide as the preferred ICS component 1
   • If LABA is needed, salmeterol has more pregnancy data but formoterol is acceptable 1

3. For patients with worsening symptoms during pregnancy:

   • Increase the dose of budesonide/formoterol before considering medication changes 1
   • For severe persistent asthma, increasing to high-dose ICS is recommended before adding systemic corticosteroids 1

Common Pitfalls to Avoid

• Discontinuing asthma medications during pregnancy due to unfounded safety concerns, which can lead to poor asthma control and increased risks to mother and fetus 1
• Failing to aggressively manage asthma exacerbations during pregnancy, which can lead to maternal hypoxia and adverse fetal outcomes 1
• Switching from formoterol to salmeterol unnecessarily if the patient was previously well-controlled on formoterol 1