Kenalog-80 (injection) Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned
Risk Summary: There is no data in pregnant women to inform a drug associated risk of adverse developmental outcomes.
Comments:
-Infants born to mothers who have received corticosteroids, especially at higher doses for longer periods of time, should be observed for signs of hypoadrenalism.
This drug crosses the placenta. Teratogenicity including increased incidence of cleft palate have occurred in animal studies with doses equivalent to human doses; however, the relevance to humans has been questioned. Most published literature regarding corticosteroid exposure during pregnancy includes oral, topical, and inhaled formulations. There are no adequate and well controlled studies in pregnant women.
Corticosteroids may result in menstrual pattern irregularities such as changes in timing and duration of menses and increased or decreased loss of blood.
AU TGA pregnancy 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 fetus having been observed.
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
Kenalog-80 (injection) Breastfeeding Warnings
Limited data exists on the use of injectable triamcinolone during breastfeeding. Systemically administered corticosteroids are present in human milk, but is unknown if intra-articular administration could provide sufficient systemic absorption to produce detectable quantities in human milk. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression. Caution should be exercised.
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-Local injections would not be expected to cause adverse effects in breastfed infants, however, there have been reports of suppressed maternal milk production.
See references
