Tretinoin / Benzoyl Peroxide (Twyneo®)

Pregnancy

The use of the combination of tretinoin / benzoyl peroxide has not been studied in pregnant humans or animals. 

However, tretinoin is best avoided during the first trimester of pregnancy because of risk of harm to the fetus. If acne treatment is needed during pregnancy, it is preferable to use other agents.

This is based on studies done on pregnant animals and some case reports of pregnant women however a direct causal association has not been established.

The effects of topical benzoyl peroxide have not been studied in pregnant animals. There are also no known studies in humans that have tested the safety of benzoyl peroxide in pregnancy. We only know that when benzoyl peroxide is applied to the skin, a small fraction of its components is absorbed and can be detected in the bloodstream. 

Category: C

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Unknown 

Caution is recommended when using tretinoin / benzoyl peroxide during breastfeeding. 

The risks of using tretinoin when breastfeeding have not been not studied, but because tretinoin is poorly absorbed by the skin after topical application the risks to the nursing infant are probably low. 

Benzoyl peroxide seems to be of low risk to the infant when used topically while breastfeeding. Although topical benzoyl peroxide use during breastfeeding has not been studied, research suggests only a small fraction of the components of topically applied benzoyl peroxide is absorbed into the bloodstream. 

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. 

If you are breastfeeding, speak with your physician before you use tretinoin / benzoyl peroxide.