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Botanical agent approved for topical treatment of external genital and perianal warts

Polyphenon E Ointment, 15% (Veregen)

KunecatechinsMEDIGENE AGBotanical agent approved for topical treatment of external genital and perianal warts

The active substance in this agent is kunecatechins, which is derived from the green tea leaves of Camellia sinensis (L) O Kuntze. The mechanism by which kunecatechins clears genital and perianal warts is unknown. FDA approved kunecatechins on October 31, 2006, for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients aged ≥18 years.

Safety. Kunecatechins is not a cure for external genital and perianal warts, and new warts may develop during or after a course of treatment. The safety of treating external genital and perianal warts for >16 weeks or for multiple treatment courses has not been established. Kunecatechins may weaken condoms and vaginal diaphragms. This agent should not be applied to open wounds. Contact of kunecatechins with the eyes, vagina, and anus also should be avoided. Local skin reactions are common; severe skin reactions also have been reported. Patients treated with kunecatechins in clinical trials also experienced phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes, vulvitis, skin ulcers, erosions in the urethral meatus, and superinfection of warts and ulcers. Rarely, patients experienced urethritis, peri-anal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, discoloration, cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia. The most common adverse events associated with kunecatechins treatment include erythema, erosion, edema, itching, burning, pain, induration, and vesicular rash.

Dosing. Kunecatechins should be applied 3 times per day to all external genital and perianal warts. Treatment should be continued until all warts are cleared but should not be continued for >16 weeks.

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