Podophyllotoxin (Condylox) use may be safe during pregnancy, according to the results of a recent study that did not find any adverse fetal outcomes associated with the therapy.
“Podophyllotoxin is an antimitotic agent primarily used in the local treatment of anogenital warts [but] data that enable the assessment of the fetal safety of podophyllotoxin use during pregnancy are lacking,” the researchers said. They investigated the risk of adverse fetal outcomes using individual-level pregnancy data from various nationwide registries in Denmark from January 1, 1997 through December 31, 2016.
The researchers compared local podophyllotoxin-exposed pregnancies with unexposed pregnancies and created 5 distinct cohorts, one for each outcome. The outcomes included major birth defects and spontaneous abortions, as well as preterm births, small-for-gestational-age (SGA) size, and stillbirths. In addition, they conducted sensitivity analyses that compared podophyllotoxin-exposed pregnancies with podophyllotoxin use before pregnancy onset.
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A total of 9229 pregnancies were included in analyses of major birth defects and 18,590 pregnancies were included in analyses of spontaneous abortions.
Major birth defects were diagnosed in 29 infants among the podophyllotoxin-exposed pregnancies cohort and in 286 infants among the unexposed cohort (3.5% vs 3.4%), the researchers observed. Among podophyllotoxin-exposed pregnancies, they found 141 ended in spontaneous abortion compared with 1626 among unexposed pregnancies (8.3% vs 9.6%).
In addition, no statistically significant associations were found between podophyllotoxin exposure during pregnancy and major birth defects (prevalence odds ratio [OR] 1.02; 95% CI, 0.69-1.50), spontaneous abortions (hazard ratio [HR] 0.87; 95% CI, 0.73-1.04), preterm births (prevalence OR 1.08; 95% CI, 0.86-1.35), SGA size (prevalence OR 1.01; 95% CI, 0.85-1.22), or stillbirths (HR 0.58; 95% CI, 0.18-1.86), the researchers stated. They found similar results in sensitivity analyses.
“Findings from this study suggest that podophyllotoxin use during pregnancy may be safe, as it did not appear to be associated with an increased risk of adverse fetal outcomes,” the researchers concluded. “These findings may help guide clinicians, patients, and drug regulatory authorities when prescribing podophyllotoxin.”
Andersson NW, Andersen JT. Association between fetal safety outcomes and exposure to local podophyllotoxin during pregnancy [published online January 08, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.4315