FDA approves topical treatment for external genital warts

March 31, 2011

The US Food and Drug Administration has approved imiquimod (Zyclara) 3.75% cream to treat external genital and perianal warts in patients 12 years of age and older. The cream is applied once daily for as long as 8 weeks, a shorter, simpler regimen than most other topical prescription treatments.

The US Food and Drug Administration has approved imiquimod (Zyclara) 3.75% cream to treat external genital and perianal warts in patients 12 years of age and older. The cream is applied once daily for as long as 8 weeks, a shorter, simpler regimen than most other topical prescription treatments.

In clinical studies, imiquimod cream safely and effectively cleared visible genital warts; the recurrence rate for patients who achieved complete clearance was 15% 12 weeks after treatment. Imiquimod treats genital warts by boosting immune response to human papillomavirus (HPV), but doesn’t eliminate it. The cream’s effect on transmission of external genital warts is unknown.

Common side effects include skin reactions in the application area: redness, swelling, sores or blisters, and weeping. New external genital warts may develop during treatment. Patients shouldn’t use the cream in or on the anus or vagina and should avoid sexual contact while it is on the skin. The cream may weaken condoms and diaphragms.