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Citric acid / lactic acid / potassium bitartrate topical Pregnancy and Breastfeeding Warnings

Citric acid / lactic acid / potassium bitartrate topical is also known as: Phexxi

Medically reviewed by Drugs.com. Last updated on Sep 15, 2020.

Citric acid / lactic acid / potassium bitartrate topical Pregnancy Warnings

Discontinue use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no need for this drug during pregnancy.
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies are not available. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Citric acid / lactic acid / potassium bitartrate topical Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

See references

References for pregnancy information

  1. "Product Information. Phexxi (citric acid/lactic ac/potass bitart top)." Evofem Biosciences, Inc., San Diego, CA.

References for breastfeeding information

  1. "Product Information. Phexxi (citric acid/lactic ac/potass bitart top)." Evofem Biosciences, Inc., San Diego, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.