Pulmicort Use In Pregnancy & Lactation

Turbuhaler: Pregnancy: Data from approximately 2000 pregnancies have not revealed any increased risk of malformations as a result of treatment with budesonide. Animal studies have shown that glucocorticosteroids can induce malformations, but this is judged not to be relevant for humans with the recommended dosage.
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
During pregnancy the aim must be the lowest effective dose of budesonide while taking account of the risk of a worsening of the asthma.
Lactation: Budesonide is excreted in breast milk. However, at therapeutic doses of Pulmicort Turbuhaler no effects on the suckling child are anticipated. Pulmicort Turbuhaler can be used during breastfeeding.
Respules: Use in pregnancy - Category A*: The benefits of asthma control outweigh any potential for an adverse pregnancy outcome.
Results from a large prospective epidemiological study and from world-wide post marketing experience indicate that inhaled budesonide during pregnancy has no adverse effects on the health of the foetus or new born child.
Inhaled glucocorticosteroids, such as budesonide, should be considered because of the lower systemic effects of doses, compared to those of oral glucocorticosteroids, required to achieve similar pulmonary responses.
*Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Use in lactation: Budesonide is excreted in breast milk. However, due to the relatively low doses used via the inhalational route the amount of drug present in the breast milk, if any, is likely to be low. Breastfeeding can be considered if the potential benefit outweighs any potential risks.