Sinecatechins topical Pregnancy and Breastfeeding Warnings
Brand names: Veregen
Sinecatechins topical Pregnancy Warnings
This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
US FDA pregnancy category: C
Animal studies have failed to reveal evidence of teratogenicity or fetal harm. In the presence of maternal toxicity, subcutaneous doses of 12 and 36 mg/kg/day from gestational days 6 to 19 resulted in reduced fetal body weights and delays in skeletal ossification. A pre- and post-natal development study in rats using vaginal administration of 0.10 and 0.15 mL/rat/day resulted in increased mortality of the dams, associated with indications of parturition complications; an increased incidence of still births was also observed (0.15 mL/rat/day dose only). There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Sinecatechins topical Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2016) "Product Information. Veregen (sinecatechins topical)." Fougera
References for breastfeeding information
- (2016) "Product Information. Veregen (sinecatechins topical)." Fougera
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.