From the Guidelines
Breo Ellipta (fluticasone furoate/vilanterol) should be used with caution during pregnancy and only when the potential benefits outweigh the risks, as there is limited data on its safety during pregnancy 1.
Key Considerations
- The safety of Breo Ellipta during pregnancy has not been well established, and animal studies have shown some adverse effects at high doses.
- Inhaled corticosteroids, such as fluticasone, are generally considered safe during pregnancy, but the combination with vilanterol in Breo Ellipta may pose additional risks 1.
- Alternative asthma or COPD medications with better-established safety profiles during pregnancy, such as certain inhaled corticosteroids alone, may be considered by healthcare providers.
- It is essential to maintain good control of asthma or COPD during pregnancy, as uncontrolled respiratory conditions can pose risks to both mother and baby 1.
Recommendations
- Pregnant women or those planning to become pregnant should consult with their healthcare provider before using Breo Ellipta.
- Healthcare providers should weigh the benefits of treating respiratory conditions against potential risks to the pregnancy and consider alternative medications with established safety profiles.
- If Breo Ellipta is prescribed during pregnancy, patients should be closely monitored for any adverse effects, and the medication should be used at the lowest effective dose.
- Patients should not stop taking their prescribed medication without consulting their healthcare provider first, as this can lead to uncontrolled respiratory conditions and pose risks to both mother and baby 1.
From the FDA Drug Label
- 1 Pregnancy Risk Summary There are insufficient data on the use of BREO ELLIPTA or its individual components, fluticasone furoate and vilanterol, in pregnant women to inform a drug-associated risk.
The FDA drug label does not provide sufficient information to directly support the use of Breo Ellipta in pregnant patients. Insufficient data exists on the use of Breo Ellipta in pregnant women, and therefore, its use in pregnancy should be approached with caution. The decision to use Breo Ellipta in a pregnant patient should be made on a case-by-case basis, considering the potential benefits and risks, and under the guidance of a healthcare provider 2.
From the Research
Safety of Breo Ellipta in Pregnant Patients
There are no research papers provided that directly address the safety of Breo Ellipta (fluticasone furoate and vilanterol) in pregnant patients.
Available Information on Breo Ellipta
- The provided studies focus on the safety and efficacy of Breo Ellipta in patients with asthma and chronic obstructive pulmonary disease (COPD) 3, 4, 5, 6, 7.
- These studies demonstrate that Breo Ellipta is well-tolerated and effective in improving lung function in patients with asthma and COPD 3, 4, 6, 7.
- Common adverse events associated with Breo Ellipta include oral/oropharyngeal candidiasis, dysphonia, and cough 4, 5.
Considerations for Pregnant Patients
- Pregnant patients should consult their healthcare provider before taking any medication, including Breo Ellipta.
- The safety of Breo Ellipta in pregnant patients has not been established in the provided studies.
- Healthcare providers may consider the potential benefits and risks of Breo Ellipta in pregnant patients, as well as alternative treatment options.