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Beclomethasone Pregnancy and Breastfeeding Warnings

Beclomethasone is also known as: Beclovent, Qvar, Qvar RediHaler, Vanceril, Vanceril DS

Beclomethasone Pregnancy Warnings

Benefit should outweigh risk AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Hypoadrenalism may occur in neonates exposed to glucocorticosteroids in utero; carefully observe neonates for signs and symptoms of hypoadrenalism. -Fetal growth should be monitored.

Systemic administration of relatively high doses in animals has shown abnormalities of fetal development including growth retardation and cleft palate. Epidemiologic data on a large number of human pregnancies has not shown adverse effects on mother or on the health of the baby with inhaled drug at 1 mg per day. Epidemiologic data is lacking on the oral administration of this drug. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Beclomethasone Breastfeeding Warnings

Most experts consider inhaled corticosteroids acceptable during breastfeeding as the presence in breastmilk is expected to be low and infant exposure negligible. No studies have specifically described the presence of this drug in animal milk or breast milk; however, it is reasonable to assume it is excreted in milk. Due to lack of specific data, benefits to the mother should be weighed against any potential risk to the breastfed infant.

Benefit should outweigh risk Excreted into human milk: Unknown Excreted into animal milk: Unknown Comment: At therapeutic doses minimal effects are expected with inhaled drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Qvar (beclomethasone)." Teva Pharmaceuticals USA, North Wales, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Qvar (beclomethasone)." Teva Pharmaceuticals USA, North Wales, PA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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