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Pregnancy of Progeffik in details
Progeffik has been not formally assigned to pregnancy category by the FDA. Progeffik vaginal inserts can be used as part of in vitro fertilization treatment for luteal phase support during the first months of pregnancy. Animal studies have revealed little to no evidence of impaired fertility or fetal harm. Studies in women have not demonstrated significant increases in fetal malformations. Progeffik is only recommended for use during pregnancy when benefit outweighs risk.
A single case of cleft palate was observed in the child of a woman using Progeffik in early pregnancy, however, causality has not been established. Rare instances of fetal death have been reported in pregnant women receiving Progeffik for unapproved indications.
Detectable amounts of Progeffik have been identified in the milk of nursing mothers, however, the effect on the nursing infant has not been determined. The manufacturer recommends that Progeffik be administered to nursing mothers only when clearly necessary.
- Human Metabolome Database (HMDB). "Progesterone: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB00018... (accessed September 18, 2017).
- FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/DataStan... (accessed September 18, 2017).