|
||
Clobrate BG Pregnancy |
||
Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Clobrate BG has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse effects were attributed to Clobrate BG. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to Clobrate BG and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reduction, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between first-trimester Clobrate BG use and birth defects.
Clobrate BG has been assigned to pregnancy category C by the FDA when given as oral troches, and pregnancy category B when used intravaginally or topically. Animals given high doses intravaginally and orally have not shown evidence of teratogenicity. In clinical trials involving women in their second and third trimester, Clobrate BG treatment of vaginal candidiasis has not been associated with fetal harm. Clobrate BG use has not been well studied during the first trimester. Clobrate BG is only recommended for use during pregnancy when benefit outweighs risk.
See references
There are no data on the excretion of Clobrate BG into human milk.
See references
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
|