FDA Approves Green Tea Extract as Topical Drug for Genital Warts

AUSTIN, Texas—The Food and Drug Administration (FDA, www.fda.gov) has approved a special extract of green tea as a prescription drug for the topical treatment of genital warts caused by the human papilloma virus (HPV). The new drug, called Verege™ Ointment, is the first prescription botanical (herbal) drug approved by FDA under the new drug amendments of 1962 that required drugs to be proven both safe and effective prior to being marketed in the United States. Polyphenon® E Ointment will be available in the United States only by prescription.

According to the American Botanical Council (ABC, www.herbalgram.org), the active drug ingredient, Polyphenon E, is a proprietary mixture of phytochemicals derived from a partially purified water extract of green tea leaves, which are fermented less than black tea leaves and, thus, retain higher levels of antioxidant catechins.

ABC reported Polyphenon E has been shown to have significant pharmacological activities when tested both internally and externally in animals and humans. To gain FDA drug approval, the safety and efficacy of Polyphenon E Ointment was studied in two prospective, randomized, double blind clinical studies involving nearly 400 adults with external genital and anal warts (ranging in number from two to 30). Test subjects applied the ointment three times daily until all warts were completely gone. Results from both of these clinical trials showed the median time to clear warts completely was 16 weeks and 10 weeks, respectively. Researchers noted changes in the skin over the site of use were the most commonly reported side effects, which included redness, itching, burning, pain/discomfort, ulceration, swelling and local hardening of the skin.