Is Flonase (fluticasone) safe during pregnancy?

From the Guidelines

Flonase (fluticasone propionate) is generally considered safe during pregnancy, as evidenced by a study published in 2016 1, which suggests that modern nasal corticosteroids, including fluticasone, can be used for CRS maintenance during pregnancy at recommended doses.

Key Points to Consider

• The study published in 2016 1 provides the most recent and highest quality evidence, and it supports the use of fluticasone propionate during pregnancy.
• Flonase has minimal systemic absorption, which reduces potential risks to the developing fetus.
• It is essential to use the lowest effective dose for the shortest duration necessary to control symptoms.
• Before using Flonase during pregnancy, it is crucial to consult with a healthcare provider to evaluate specific situation and symptoms.
• Non-medication approaches, such as saline nasal sprays, humidifiers, or avoiding allergen triggers, may be recommended first.

Important Considerations

• The 2016 study 1 found no detectable influence on maternal cortisol or fetal growth, and no difference in pregnancy outcome was reported.
• Another study published in 2008 1 also supports the use of intranasal corticosteroids, including fluticasone propionate, during pregnancy, citing their safety and efficacy profile.
• The decision to use Flonase during pregnancy should be made in consultation with a healthcare provider, taking into account the benefits and risks of treatment.

Recommendations

• Use Flonase at the lowest effective dose for the shortest duration necessary to control symptoms.
• Consult with a healthcare provider before using Flonase during pregnancy to evaluate specific situation and symptoms.
• Consider non-medication approaches first, such as saline nasal sprays, humidifiers, or avoiding allergen triggers.
• Follow the prescribed dosage carefully and report any unusual symptoms to the healthcare provider promptly.

From the FDA Drug Label

Pregnancy Teratogenic effects Pregnancy Category C Subcutaneous studies in the mouse and rat at 45 and 100 mcg/kg, respectively (approximately equivalent to and 4 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m basis) revealed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification 2 In the rabbit, fetal weight reduction and cleft palate were observed at a subcutaneous dose of 4 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/m basis) 2 However, no teratogenic effects were reported at oral doses up to 300 mcg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mcg/m basis), of fluticasone propionate to the rabbit. No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration (see ) 2CLINICAL PHARMACOLOGY Fluticasone propionate crossed the placenta following oral administration of 100 mcg/kg to rats and 300 mcg/kg to rabbits (approximately 4 and 25 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m basis). 2 There are no adequate and well-controlled studies in pregnant women Fluticasone propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Flonase Safety During Pregnancy:

• The FDA drug label indicates that fluticasone propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Pregnancy Category C means that there is a potential risk to the fetus, but the benefits of the medication may outweigh the risks in certain situations.
• Key Points:
  • No adequate and well-controlled studies in pregnant women
  • Potential risk to the fetus, including fetal toxicity and teratogenic effects
  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus 2 2

From the Research

Safety of Flonase During Pregnancy

• The safety of Flonase (fluticasone propionate) during pregnancy has been evaluated in several studies 3, 4.
• A study published in 2018 found that intranasal fluticasone propionate might be a safe option during pregnancy, although its efficacy is questionable 3.
• Another study published in 2003 compared the effectiveness of fluticasone propionate nasal spray with a combination of loratadine and montelukast in treating seasonal allergic rhinitis, but did not specifically address pregnancy 4.
• There is no significant association between congenital organ malformations and the intranasal use of fluticasone propionate, according to the 2018 study 3.
• The risk-benefit ratio should always be considered before prescribing any intranasal corticosteroid sprays, including Flonase, during pregnancy 3.

Comparison with Other Treatments

• Studies have compared the effectiveness of fluticasone propionate with other treatments, such as loratadine and montelukast 4, and bilastine versus loratadine 5.
• However, these studies did not specifically address the safety of Flonase during pregnancy.
• A study published in 2006 found that adding levocetirizine to fluticasone propionate did not provide significant additional benefits in treating seasonal allergic rhinitis 6.

Overall Safety

• The available evidence suggests that fluticasone propionate, the active ingredient in Flonase, is generally safe to use during pregnancy, but its efficacy is questionable 3.
• As with any medication, the risk-benefit ratio should be carefully considered before prescribing Flonase to pregnant women 3.