Is ciclopirox (antifungal medication) safe during pregnancy?

From the Guidelines

Ciclopirox is generally considered safe for use during pregnancy when applied topically, as it has limited systemic absorption and is classified as FDA Pregnancy Category B. When considering the use of ciclopirox during pregnancy, it's essential to weigh the benefits of treating the fungal infection against any potential risks to the fetus. The provided evidence does not directly address the safety of ciclopirox during pregnancy 1. However, based on the general properties of topical antifungal medications and their limited systemic absorption, ciclopirox is likely to pose minimal risk to the fetus when used as directed. Key points to consider when using ciclopirox during pregnancy include:

• Topical application reduces systemic absorption and potential fetal exposure
• Use only when clearly needed and under healthcare provider supervision
• Benefit of treating the fungal infection should outweigh any potential risks
• Alternative antifungals like clotrimazole or miconazole may also be considered in some cases It's crucial to note that while azole antifungals have been associated with teratogenic effects, particularly when used in high doses during the first trimester 1, ciclopirox is not an azole antifungal, and its safety profile is more closely related to its limited systemic absorption when used topically. Therefore, topical ciclopirox can be a reasonable option for pregnant women requiring treatment for fungal infections, but its use should always be guided by a healthcare provider to ensure the benefits outweigh any potential risks.

From the FDA Drug Label

Pregnancy Category B Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77,23, or 38. 5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14,8,17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92. 4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Ciclopirox is classified as Pregnancy Category B. Although teratology studies did not indicate significant fetal malformations, there are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 2.

From the Research

Safety of Ciclopirox during Pregnancy

• There is limited information available on the safety of ciclopirox during pregnancy 3, 4.
• Ciclopirox is a topical antimycotic agent that is not related to azoles or any other class of antifungal agents, and its mechanism of action is different from that of other topical antifungal drugs 4.
• The safety features of ciclopirox are well known, and the topical drug is devoid of systemic adverse reactions 4.
• Mild local reactions characterized by a burning sensation of the skin, irritation, redness, pain or pruritus, generally in less than 5% of treated patients, can be observed following skin and vaginal application 4.
• There is no direct evidence available on the use of ciclopirox during pregnancy, but its topical application and lack of systemic absorption suggest that it may be safe to use during pregnancy 4.

Comparison with Other Antifungal Agents

• Other antifungal agents, such as oral antifungals, have been associated with congenital abnormalities and spontaneous abortions 3.
• The use of antifungal drugs during pregnancy needs careful consideration, and the benefits and risks of treatment should be weighed 3.
• Ciclopirox has a unique mechanism of action and a low potential for the development of resistance in pathogenic fungi, which may make it a safer alternative to other antifungal agents during pregnancy 4.

Clinical Use of Ciclopirox

• Ciclopirox is effective in the treatment of various superficial fungal infections, including tinea corporis/cruris, tinea pedis, cutaneous candidiasis, pityriasis (tinea) versicolor, and seborrheic dermatitis 5.
• The lotion and cream formulations of ciclopirox are effective in many types of infection, and the new ciclopirox gel 0.77% formulation is also indicated for the treatment of seborrheic dermatitis of the scalp, interdigital tinea pedis and tinea corporis 5.