From the Guidelines
Symbicort can be used during pregnancy when the benefits outweigh the risks, particularly for women who need it to control their asthma. Symbicort contains budesonide (a corticosteroid) and formoterol (a long-acting beta-agonist). According to the most recent and highest quality study 1, budesonide has more safety data in pregnancy than other inhaled corticosteroids and is generally considered acceptable to use. The study notes that at usual doses, inhaled corticosteroids like budesonide have not been associated with increased risk of major malformations, intra-uterine growth restriction, pre-term delivery, or low birthweight.
Key Considerations
- Poorly controlled asthma during pregnancy poses greater risks to both mother and baby than the potential risks of medication 1.
- The lowest effective dose of Symbicort should be used to maintain asthma control.
- Women who become pregnant while using Symbicort should consult their healthcare provider, but should not abruptly stop their medication as this could lead to worsening asthma symptoms.
- Regular monitoring during pregnancy is recommended to adjust dosing as needed.
- For women with mild asthma or those concerned about medication use during pregnancy, their healthcare provider might consider alternative management strategies.
Safety of Components
- Budesonide is preferred due to its extensive safety data in pregnancy 1.
- Formoterol, as a long-acting beta-agonist, has a pharmacologic and toxicologic profile similar to short-acting beta-agonists, which have been used safely during pregnancy 1.
Conclusion is not needed as per the guidelines, the above information is sufficient to make a decision.
From the FDA Drug Label
There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide In animal reproduction studies, budesonide and formoterol fumarate dihydrate, administered by the inhalation route, was teratogenic, embryocidal, and reduced fetal weights in rats at less than the maximum recommended human daily inhalation dose (MRHDID) on a mcg/m2 basis Because of the potential for beta-agonist interference with uterine contractility, use of budesonide and formoterol fumarate dihydrate during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
The FDA drug label does not provide direct information on contraindications of Symbicort (budesonide and formoterol) in pregnancy. However, based on the available information:
- Pregnancy category: There are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate in pregnant women.
- Animal studies: Budesonide and formoterol fumarate dihydrate was teratogenic, embryocidal, and reduced fetal weights in rats.
- Use during labor: The use of budesonide and formoterol fumarate dihydrate during labor should be restricted to those patients in whom the benefits clearly outweigh the risk due to the potential for beta-agonist interference with uterine contractility. It is recommended to exercise caution when using Symbicort in pregnant women, especially during labor, and to weigh the benefits against the potential risks 2, 2, 2.
From the Research
Contraindications to Symbicort in Pregnancy
There are no research papers provided to directly answer the question about contraindications to Symbicort (budesonide and formoterol) in pregnancy.
Available Information on Symbicort
- The provided studies discuss the use of Symbicort in the treatment of asthma and COPD, but do not mention its use in pregnancy 3, 4, 5, 6, 7.
- These studies focus on the efficacy and safety of Symbicort in patients with asthma and COPD, and do not address its contraindications in pregnancy.
- The studies suggest that Symbicort is a safe and effective treatment option for patients with asthma and COPD, but do not provide information on its use in pregnant women 3, 4, 5, 6, 7.
Lack of Relevant Information
- There is no information available in the provided studies to assist in answering the question about contraindications to Symbicort in pregnancy.
- Further research would be needed to determine the safety and efficacy of Symbicort in pregnant women.