From the Guidelines
Azelaic Acid Topical Safety During Pregnancy
Azelaic acid topical is considered safe for use during pregnancy. According to the guidelines of care for the management of acne vulgaris published in the Journal of the American Academy of Dermatology 1, the risk of fetal harm from topical azelaic acid is not expected due to limited systemic absorption.
- The recommended use of azelaic acid topical during pregnancy involves applying a 15% or 20% azelaic acid gel or foam to the affected area twice daily.
- It is crucial to use azelaic acid topical under the guidance of a healthcare provider, especially during the first trimester, and with careful monitoring for any potential adverse effects 1.
- While the guidelines do not specify a maximum duration for azelaic acid topical use during pregnancy, it is generally recommended to limit the use of any topical medication to the shortest duration necessary to achieve the desired therapeutic effect.
- Salicylic acid, another common topical acne treatment, can be used in pregnancy but with limitations, such as limited area of exposure and duration of therapy 1.
From the FDA Drug Label
Pregnancy Teratogenic Effects Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Azelaic acid topical safety during pregnancy is not well established due to the lack of adequate and well-controlled studies in pregnant women. Although animal studies showed embryotoxic effects at high doses, no teratogenic effects were observed. However, as a precaution, this drug should be used during pregnancy only if clearly needed 2.
From the Research
Safety of Azelaic Acid Topical During Pregnancy
- The safety of azelaic acid topical during pregnancy is supported by a study published in the Journal of the American Board of Family Medicine, which recommends topical azelaic acid or benzoyl peroxide as baseline therapy for acne in pregnancy 3.
- This study suggests that topical azelaic acid is a safe option for pregnant women, as it does not have any known teratogenic effects.
- Another study published in Postepy dermatologii i alergologii discusses the multiple uses of azelaic acid in dermatology, including its anti-inflammatory, antioxidant, and antimicrobial properties, but does not specifically address its safety during pregnancy 4.
- However, the study published in the Journal of the American Board of Family Medicine provides evidence that azelaic acid is considered safe for use during pregnancy, and its use is recommended as a first-line treatment for acne in pregnant women 3.
Potential Side Effects and Interactions
- The studies reviewed do not report any significant side effects or interactions associated with the use of azelaic acid topical during pregnancy.
- However, as with any medication, it is essential to follow the recommended dosage and consult a healthcare provider before using azelaic acid topical during pregnancy.
- The study published in Expert opinion on pharmacotherapy reports that azelaic acid 15% gel is well-tolerated and has a favorable safety profile, with mild and transient local skin irritation being the most common side effect 5.
Comparison with Other Treatments
- A study published in Archives of dermatology compares the efficacy and safety of 15% azelaic acid gel with 0.75% metronidazole gel in the treatment of papulopustular rosacea, but does not specifically address its use during pregnancy 6.
- Another study published in Dermatology compares the efficacy of 20% azelaic acid cream with a sequential therapy in the treatment of melasma, but excludes pregnant women from the study population 7.
- The study published in the Journal of the American Board of Family Medicine provides the most relevant information on the safety of azelaic acid topical during pregnancy, and its use is recommended as a first-line treatment for acne in pregnant women 3.