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.

See references

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 references

Further information

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