Pregnancy of Naldec in details
In a review of deliveries to Michigan Medicaid patients during 1980 to 1983, 1489 exposures to Naldec any time during pregnancy were recorded. A total of 128 birth defects were reported (91 expected). An association was seen between Naldec and laryngotracheal anomalies, pyloric stenosis, intestinal fixation anomalies, upper limb defects, skull/face anomalies, and musculoskeletal defects. The statistical significance of these associations is not known. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The Collaborative Perinatal Project monitored 50,282 mother-child pairs and recorded 726 first-trimester exposures and 2489 exposures to Naldec anytime during pregnancy. Possible associations between Naldec and first trimester use and Naldec include hypospadias (4), eye and ear abnormalities (7, statistically significant), polydactyly (6), cataract (3), and pectus excavatum (7). For use anytime during pregnancy a possible association was noted between Naldec use and congenital dislocation of hip (12).
Naldec has been assigned to pregnancy category C. There are no controlled data in human pregnancy. Naldec should only be used during pregnancy when benefit outweighs the risk to the fetus.
See references
Naldec breastfeeding
There are no data on the excretion of Naldec into human milk.
See references
References for pregnancy information
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
References for breastfeeding information
- "Product Information. Dexatrim (Naldec)." Thompson Medical Company Inc, West Palm Beach, FL.
- "Product Information. Propagest (Naldec)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
- "Product Information. Rhindecon (Naldec)." McGregor Pharmaceuticals Inc, Largo, FL.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
