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Deflazacort Pregnancy and Breastfeeding Warnings

Deflazacort is also known as: Emflaza

Deflazacort Pregnancy Warnings

Benefit should outweigh risk US FDA pregnancy category: Not Assigned Comment: Infants exposed to higher doses in utero should be observed for signs and symptoms of hypoadrenalism.

This drug readily crosses the placenta. Teratogenicity including increased incidence of cleft palate have occurred with corticosteroid administration in animal studies, although, the relevance to humans has been questioned. There are no specific animal studies performed with this drug. A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate (increased from 1 out of 1000 to 3 to 5 out of 1000 infants). Two prospective case-controlled studies have shown decreased birth weight in infants exposed to maternal corticosteroids in utero. There are no adequate and well controlled studies in pregnant women. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Deflazacort Breastfeeding Warnings

Corticosteroids have been detected in breast milk in low amounts, however, specific information on this drug in breast milk is unknown. Theoretically, the presence of exogenous corticosteroids in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects in breast fed babies, but in doses of up to 50 mg per day, this drug is unlikely to produce a degree of adrenal suppression that would affect the breastfed infant. Higher doses may be expected to affect the degree of adrenal suppression and should be used with caution. There are no data on the effects on milk production.

Benefit should outweigh risk Excreted into human milk: Unknown Comments: Doses of up to 50 mg daily are unlikely to cause systemic effects in the breastfed infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Emflaza (deflazacort)." Marathon Pharmaceuticals, Deerfield, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Emflaza (deflazacort)." Marathon Pharmaceuticals, Deerfield, IL.

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