Treatment of Acne in Pregnancy

Anna L. Chien; Ji Qi; Barbara Rainer; Dana L. Sachs; Yolanda R. Helfrich

doi:10.3122/jabfm.2016.02.150165

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Table 1. Food and Drug Administration Pregnancy Risk Categories

Category A	Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
Category B	Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women.
	or
	Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.
Category C	Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.
	or
	No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
Category D	Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
Category X	Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.
NA	A US Food and Drug Administration pregnancy rating is not available.

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Table 2. Treatment Algorithm for Acne in Pregnancy

Type of Acne	Treatment	FDA Pregnancy Drug Class	Evidence Rating
Noninflammatory
Comedonal	Azelaic acid	B	Likely to be beneficial
Inflammatory
Mild to moderate	Azelaic acid +	B	Likely to be beneficial
	Benzoyl peroxide or	C	Beneficial
	Topical erythromycin or	B	Beneficial
	Topical clindamycin +	B	Beneficial
	Benzoyl peroxide	C	Beneficial
Moderate to severe	Oral erythromycin or	B	Likely to be beneficial
	Oral cephalexin +	B	^*
	Benzoyl peroxide with or without	C	Beneficial
	Azelaic acid or	B	Likely to be beneficial
	Intralesional steroid injections	C	^*
Fulminant	Oral erythromycin +	B	Likely to be beneficial
	Benzoyl peroxide +	C	Beneficial
	Azelaic acid +	B	Likely to be beneficial
	Oral prednisone(short-term)	C	^*

Data from Ref. 37.
↵* Evidence of a drug's benefit is not discussed in Ref. 37.

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Table 3. Selected Topical Agents for Acne

Agent	FDA Category	Mechanism of Action	Available Formulations	Notes
Azelaic acid	B	Antimicrobial Comedolytic Anti-inflammatory Antityrosinase activity	Cream (20%; approved for acne) Gel (15%; approved for rosacea)	Monotherapy is possible No known bacterial resistance Can improve postinflammatory hyperpigmentation
Benzoyl peroxide	C	Antibacterial Comedolytic Anti-inflammatory	Wash, bar, pad, gel, mask, foam, lotion, cream (2.5–10%)	Monotherapy is possible No known bacterial resistance Can cause bleaching
Salicylic acid	C	Comedolytic Keratolytic	Lotion, cleanser, gel, cream, foam, soap, toner, pads (0.5- 6%)	Generally well-tolerated by patients Less effective than azelaic acid or benzoyl peroxide
Erythromycin	B	Antibacterial	Gel, solution, pad, ointment (2%) Erythromycin/benzoyl peroxide gel (3%/5%)	Should not to be used as monotherapy Bacterial resistance is diminished by combining with benzoyl peroxide
Clindamycin	B	Antibacterial	Gel, lotion, solution, foam, swab (1%) Clindamycin/benzoyl peroxide gel (1%/5%, 1.2%/2.5%)	Should not to be used as monotherapy Use with caution in patients with a history of gastrointestinal disease Bacterial resistance is diminished by combining with benzoyl peroxide
Tazarotene	X	Comedolytic Anti-inflammatory	Cream, gel, foam (0.05%/0.1%)	Contraindicated in pregnancy
Tretinoin	C	Comedolytic Anti-inflammatory	Gel (0.01%/0.025%/0.05%), microsphere gel (0.04%/0.08%/0.1%), cream (0.02–0.1%), topical solution (0.05%)	Not recommended in pregnancy
Adapalene	C	Comedolytic Anti-inflammatory	Lotion, cream (0.1%) Gel (0.1%/0.3%) Adapalene/benzoyl peroxide gel (0.1%/2.5%)	Not recommended in pregnancy
Dapsone	C	Anti-inflammatory Antimicrobial	Gel (5%)	Low risk of maternal anemia, neonatal hyperbilirubinemia, and hemolytic anemia in patients with G6PD deficiency (for topical dapsone)

FDA, US Food and Drug Administration; G6PD, glucose-6-phospate dehydrogenase.

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Table 4. Selected Oral Antibiotics for Acne

Agent	FDA Pregnancy Category	Dosage	Notes
Erythromycin	B	250–500 mg, 2–4 times/day	Long-term use in pregnancy has not been studied Bacterial resistance is diminished by combining with topical benzoyl peroxide Hepatotoxicity is associated with erythromycin estolate; not recommended for pregnancy
Azithromycin	B	Dosing routine may vary, eg, 250 mg, 3 times/week	Off-label indication More flexible dosing regimen for less compliant patients
Cephalexin	B	500 mg twice daily	Concern for Staphylococcus resistance
Amoxicillin	B	250–500 mg twice daily	Use in early pregnancy may increase risk of oral clefts
Trimethoprim/sulfamethoxazole	C	160/800 mg twice per day	Exposure during the first trimester is associated with miscarriage
Tetracycline	D	250–500 mg twice daily	Toxic effects on fetal teeth and bone Avoid in pregnancy
Minocycline or doxycycline	D	50–100 mg	Toxic effects on fetal teeth and bone
		once or twice per day	Avoid in pregnancy

FDA, US Food and Drug Administration.

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Table 5. Strength of Recommendation Taxonomy: Key Recommendations for Acne in Pregnancy

Clinical Recommendation	Evidence Rating^*	References
Topical azelaic acid (15% or 20%) and benzoyl peroxide (2.5–5%) are effective baseline agents.	B	36, 37
Topical erythromycin in combination with benzoyl peroxide (5% maximum) can be used as alternative treatment for inflammatory acne.	C	36
Topical clindamycin in combination with benzoyl peroxide can be used as alternative treatment for inflammatory acne.	C	37
Topical dapsone is a newer anti-acne agent with less available safety data and should be used with caution in pregnant patients.	C	18
Topical and oral antibiotics (eg, erythromycin) should be used in combination with benzoyl peroxide to reduce the risk of bacterial resistance.	C	11
Oral cephalexin can be used in moderate to severe inflammatory acne.	C	25
Intralesional steroid injections can be used to treat moderate to severe inflammatory acne.	C	33
Oral glucocorticoids can be used short term to treat fulminant acne after the first trimester.	C	36

↵* B = inconsistent or limited-quality patient-oriented evidence; C = consensus, disease-oriented evidence, usual practice, expert opinion, or case series. For information about the Strength of Recommendation Taxonomy evidence rating system, go to http://www.aafp.org/afpsort.xml.

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Table 6. Costs of Agents

Topical Treatments		Oral Treatments		Procedures
Agent	Cost	Agent	Cost	Agent	Cost
Benzoyl peroxide	$	Azithromycin	$	Glycolic acid peel	$$$
Salicylic acid	$	Amoxicillin	$	Photodynamic therapy	$$$
Topical erythromycin	$	Cephalexin	$
Topical clindamycin	$	Prednisone	$
Benzamycin (erythromycin/benzoyl peroxide)	$$	Zinc	$
Benzaclin (clindamycin/benzoyl peroxide)	$$	Erythromycin	$$
Azelaic acid	$$$
Topical dapsone	$$$

Estimated costs (actual costs may vary depending on insurance plans, pharmacy, location, and other variables): $ = $0–$50; $$ = $50–$150; $$$ = ≥$150.