Pregnancy
Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide.
However, there is no data on the use of the combination of topical tretinoin and benzoyl peroxide in pregnant women.
There are reports of malformations in newborns affecting the brain with maternal use of topical tretinoin, but the significance of these human case reports in terms of risk to the fetus is not known.
Animal reproductive studies have not been conducted with the combination of tretinoin / benzoyl peroxide. However, topical administration of tretinoin in pregnant rats during early pregnancy was associated with malformations at doses greater than 1 mg tretinoin/kg/day, which is approximately 5 times the maximum recommended topical human dose.
Be sure to talk to your doctor before using tretinoin / benzoyl peroxide when pregnant or planning to become pregnant.
>> More on How to Treat Acne During Pregnancy
Breastfeeding
It is not known whether tretinoin / benzoyl peroxide is excreted in human milk. Because many drugs are excreted in human milk, a woman and her doctor should decide whether to discontinue nursing before using tretinoin / benzoyl peroxide, taking into account the importance of the drug use to the mother.
Do not apply tretinoin / benzoyl peroxide to the nipple area and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with tretinoin / benzoyl peroxide. Make sure to wash your hands after the application of tretinoin / benzoyl peroxide.
References
- DailyMed (2024). TWYNEO® – tretinoin and benzoyl peroxide cream. [online] Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27208dff-e376-4c18-b56e-0a260f685a39. [Accessed 19 Sept. 2024].
- Food and Drug Administration (FDA). (2024). TWYNEO® (Tretinoin and Benzoyl Peroxide). [online] Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214902s000lbl.pdf. [Accessed 19 Sept. 2024].
- Epocrates.com. (2024). Tretinoin and Benzoyl Peroxide. [online] Available at: https://www.epocrates.com/online/drugs/10282/twyneo#adult-dosing. [Accessed 19 Sept. 2024].