The treatment of acne in pregnant and lactating patients presents a challenge to dermatologists due to concerns for maternal and fetal safety |
There is a lack of clinical studies on the safety and efficacy of common acne treatments in pregnancy and lactation |
Acne management in these populations should begin with a stepwise approach, with considerations for acne severity and trimester-specific fetal risk |
Management of mild-to-moderate acne should start with topical therapies, including benzoyl peroxide, azelaic acid, or other keratolytic agents |
Refractory acne may require systemic or procedural treatments with careful consideration of fetal risk |
Introduction
Acne Management During Preconception and Pregnancy Planning
Drug | Washout period | Pregnancy safety rating | Notes | ||
---|---|---|---|---|---|
FDA | Briggs | ||||
Contraindicated | Isotretinoin | Discontinue 1 month before conception | X | Contraindicated | Contraindicated |
Spironolactone | Discontinue 1 month before conception | C | Data suggest risk | Contraindicated | |
Tazarotene | None | X | Contraindicated | Contraindicated | |
Trimethoprim/sulfamethoxazole | None | B-C | Data suggest risk | Contraindicated | |
Not recommended | Other topical retinoids (e.g., adapalene, tretinoin, trifarotene) | None | C | Data suggest risk | Not recommended, but likely low risk |
Amoxicillin | None | B | Compatible | Not recommended during 1st trimester | |
Oral erythromycins (base and ethylsuccinate) | None | B | Compatible (estolate contraindicated) | Not recommended during 1st trimester | |
Oral metronidazole | None | B | Low risk | Not recommended during 1st trimester | |
Oral corticosteroids | None | C | Data suggest risk | Not recommended during 1st trimester |
Acne Management During Pregnancy
Category (FDA, Hale) | Pregnancy: previous FDA pregnancy risk | Lactation: Hale lactation risk |
---|---|---|
A, L1 Compatible | Adequate well-controlled studies failed to demonstrate risk in the 1st trimester | Adequate well-controlled studies failed to demonstrate risk |
B, L2 Probably Compatible but Potential Risk | Animal studies failed to demonstrate risk; no adequate studies in humans | Limited studies show no increase in adverse effects |
C, L3 Probably Compatible but Potential Risk | Animal studies showed an adverse effect; no adequate studies in humans; potential benefit may warrant use | Lack of or limited studies show minimal non-threatening adverse effects; potential benefit may warrant use |
D, L4 Likely Hazardous | Evidence of human fetal risk; potential benefit may warrant use | Evidence of risk to infant; potential benefit may warrant use |
X, L5 Contraindicated | Human or animal studies demonstrated fetal abnormalities; risks outweigh any potential benefit | Human studies demonstrated risk to infants; risks outweigh potential benefit |
Acne severity | Drug | Pregnancy safety rating | Trimester-specific safety | |||
---|---|---|---|---|---|---|
FDA | Briggs | 1st | 2nd | 3rd | ||
Mild-to-moderate | Azelaic acid | B | – | ✓ | ✓ | ✓ |
Benzoyl peroxide | C | – | ✓ | ✓ | ✓ | |
Salicylic or glycolic acids | – | – | ✓ | ✓ | ✓ | |
Topical clindamycin + BPO | B | Compatible | ✓ | ✓ | ✓ | |
Topical sodium sulfacetamide ± sulfur | C | – | ✓ | ✓ | ✓ | |
Topical metronidazole + BPO | B | – | ✓ | ✓ | ✓ | |
Topical Dapsone + BPO | C | Compatible | ✓ | ✓ | X | |
Moderate-to-severe | Oral amoxicillin | B | Compatible | X | ✓ | ✓ |
Oral cephalexin | B | Compatible | ✓ | ✓ | ✓ | |
Oral erythromycins (base and ethylsuccinate) | B | Compatible (except estolate) | X | ✓ | ✓ | |
Oral azithromycin | B | Compatible | ✓ | ✓ | ✓ | |
Oral clindamycin | B | Compatible | ✓ | ✓ | ✓ | |
Limited data: consider for fulminant or refractory | Intralesional corticosteroids | C | Data suggest risk | ✓ | ✓ | ✓ |
Oral corticosteroids | C | Data suggest risk | X | ✓ | ✓ | |
Oral metronidazole | B | Low risk | X | ✓ | ✓ | |
Oral tetracyclines | D | Contraindicated in 2nd and 3rd trimesters | ✓ | X | X | |
Light and laser therapies | – | – | ✓ | ✓ | ✓ | |
Contraindicated | Isotretinoin | X | Contraindicated | X | X | X |
Spironolactone | C | Data suggest risk | X | X | X | |
Trimethoprim-sulfamethoxazole | B-C | Data suggest risk | X | X | X | |
Tazarotene | X | Contraindicated | X | X | X | |
Other topical retinoids (e.g., adapalene, tretinoin, trifarotene) | C | Contraindicated | X | X | X | |
Clascoterone | – | – | No data available |
Acne Management During Lactation
Acne severity | Drug | Lactation safety rating | ||
---|---|---|---|---|
Hale | AAP | LactMed | ||
Mild -to-moderate | Benzoyl peroxide | L2 | – | Low risk |
Azelaic acid | L3 | – | Low risk | |
Salicylic or glycolic acids | L3 | – | Acceptable | |
Topical clindamycin + BPO | L2 | Compatible | Unlikely to be of concern | |
Topical sodium sulfacetamide ± sulfur | L2 | – | – | |
Topical retinoids | L3 | – | Low risk (limit tazarotene to < 20% BSA) | |
Topical metronidazole + BPO | L3 | Of concern | Unlikely to be of concern | |
Moderate-to-severe | Oral amoxicillin | L1 | Compatible | Acceptable |
Spironolactone | L2 | Compatible | Acceptable | |
Oral cephalexin | L2 | Compatible | Acceptable | |
Oral azithromycin | L2 | – | Unlikely to be of concern | |
Oral clindamycin | L2 | Compatible | Low risk (alternate drug preferred) | |
Oral erythromycins | L3 | Compatible | Acceptable (few cases of pyloric stenosis with use in first 2 weeks of breastfeeding) | |
Trimethoprim/sulfamethoxazole | L2/L3 | Compatible | Acceptable (avoid in hyperbilirubinemia, G6PD deficiency, and prematurity) | |
Limited data: consider for fulminant or refractory | Intralesional corticosteroids | L3 | – | – |
Oral corticosteroids | L2 | Compatible | Acceptable (short-term use only; Wait 4 h after intake before breastfeeding) | |
Oral metronidazole | L2 | Of concern | Varying concern (discontinue breastfeeding for 12–24 h after single-dose therapy) | |
Oral tetracyclines | L3–L4 | Compatible | Acceptable (short-term use only) | |
Clascoterone | – | – | – | |
light and laser therapies | – | – | – | |
Isotretinoin | L5 | – | No recommendation (alternate drug preferred) | |
Topical dapsone | L4 | Compatible | Likely of concern (alternate drug preferred) |