There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy or lactation. However, studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.
Pregnancy: There are no relevant clinical data on the use of Innovair in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Because of the tocolytic actions of β2-sympathomimetic agents particular care should be exercised in the run up to delivery. Formoterol should not be recommended for use during pregnancy and particularly at the end of pregnancy or during labour unless there is no other (safer) established alternative.
Innovair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Lactation: There are no relevant clinical data on the use of Innovair in lactation in humans. Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids.
While it is not known whether formoterol passes into human breast milk, it has been detected in the milk of lactating animals. Administration of Innovair to women who are breastfeeding should only be considered if the expected benefits outweigh the potential risks.