What are the effects of Albuterol (Salbutamol) on pregnancy?

From the Guidelines

Albuterol is considered safe to use during pregnancy for women with asthma or bronchospasm, as it has an excellent safety profile and the greatest amount of data related to safety during pregnancy. According to the most recent and highest quality study 1, maintaining asthma control during pregnancy is crucial for the health and well-being of both the mother and her baby. Uncontrolled asthma increases the risk of perinatal mortality, pre-eclampsia, preterm birth, and low-birth-weight infants, making it safer for pregnant women to be treated with asthma medications than to have asthma symptoms and exacerbations.

Key Points

• Albuterol is the preferred short-acting beta 2-agonist for treating symptoms as needed in patients with intermittent asthma 1
• The standard dosing for acute symptoms remains 2 puffs (90 mcg per puff) every 4-6 hours as needed via metered-dose inhaler
• For maintenance therapy in pregnant women with persistent asthma, albuterol should be used as a rescue medication while controller medications like inhaled corticosteroids form the foundation of treatment
• Inhaled corticosteroids, such as budesonide, are the preferred long-term control medication, with the most data available on their safety during human pregnancy 1

Monitoring and Treatment

• Monthly evaluations of asthma are recommended to allow for stepping up therapy if necessary and stepping down therapy if possible 1
• Maintaining good asthma control should be the priority during pregnancy, as maternal hypoxia presents a far greater risk to fetal development than exposure to asthma medications 1

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category C Albuterol has been shown to be teratogenic in mice when given subcutaneously in doses corresponding to 1. 25 times the human nebulization dose (based on a 50 kg human). There are no adequate and well-controlled studies in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A reproduction study in CD-1 mice with albuterol (0.025,0.25, and 2.5 mg/kg subcutaneously, corresponding to 0.125,1.25, and 12. 5 times the maximum human nebulization dose, respectively) showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. None were observed at 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses treated with 2. 5 mg/kg isoproterenol (positive control). A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses at 50 mg/kg, corresponding to 250 times the maximum nebulization dose for a 50-kg human During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Labor and Delivery Oral albuterol has been shown to delay preterm labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop preterm labor or prevent labor at term Therefore, cautious use of albuterol sulfate inhalation solution is required in pregnant patients when given for relief of bronchospasm so as to avoid interference with uterine contractibility.

The effects of Albuterol (Salbutamol) on pregnancy are:

• Teratogenic effects: Albuterol has been shown to be teratogenic in mice and rabbits, with an increased incidence of cleft palate and cranioschisis.
• Pregnancy category: Albuterol is classified as Pregnancy Category C, indicating that it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Congenital anomalies: Various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol.
• Labor and delivery: Oral albuterol may delay preterm labor, but cautious use is required to avoid interference with uterine contractibility. According to the study 2.

From the Research

Effects of Albuterol on Pregnancy

• The effects of Albuterol (Salbutamol) on pregnancy can be understood through various studies, including those on asthma treatment during pregnancy 3.
• According to a study published in 1997, inhaled beta 2-agonists, such as Albuterol, are recommended for managing mild asthma during pregnancy 3.
• Another study from 1994 found that short-term circulatory effects of inhaled Albuterol had no significant impact on maternal and fetal circulations in 12 asthmatic patients between 33 and 39 weeks' gestation 4.

Safety and Efficacy

• A study published in 1984 discussed the pharmacology, pharmacokinetics, and clinical use of Albuterol, highlighting its effectiveness in treating asthma but also noting potential side effects such as decreased plasma potassium levels and increased plasma glucose levels 5.
• The safety of Albuterol during pregnancy is considered in the context of managing asthma, with the understanding that uncontrolled asthma poses risks to both mother and fetus 3.
• Comparisons with other treatments, like formoterol fumarate, have shown Albuterol to be effective in controlling acute asthma exacerbations, although formoterol may offer rapid and long-lasting bronchodilation 6.

Administration and Dosage

• The administration of Albuterol can vary, including inhalation, nebulizer solutions, and parenteral preparations, each with different systemic concentrations and side effect profiles 5.
• A study from 1996 compared continuous vs intermittent Albuterol administration at high and low doses in adults with severe acute asthma, finding that continuous nebulization resulted in greater improvement in FEV1 7.
• The choice of dosage and administration method for Albuterol during pregnancy should consider the need to control asthma symptoms while minimizing potential side effects 3, 4.