No longer just for drinking, green tea is now part of an ointment used for the topical treatment of genital warts. The Food & Drug Administration recently approved the new therapy for both external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years of age and older. Called Veregen, the Rx botanical was developed by German company MediGene. It contains 15% kunecatechins, a defined green tea extract.
"It is unknown how the kunecatechins work," said Jennifer L. Donovan, Ph.D., research assistant professor, Clinical Neuroscience Division, Medical University of South Carolina. The kunecatechins are a defined mixture of catechins derived from a water extract of green tea leaves, and catechins are potent antioxidants that have anti-inflammatory activities-although these properties may not be responsible for their effects, she explained. "At high concentrations, one of the main catechins, epigallocatechin-3-gallate, has considerable effect on cell signaling, which controls the rates of cell proliferation and cell death. However, more work is needed to determine if changes in cell signaling are responsible for the clearance of the warts."
According to the prescribing information, pharmacists should remember to remind patients that Veregen is approved for external use only and should not be used to treat warts caused by the human papilloma virus in the vagina, cervix, or inside the anus. Patients should also be advised not to use the ointment on any open wounds or to expose the area treated with Veregen to sunlight, sunlamps, or tanning beds.
The ointment, which is brown in color, is also known as Polyphenon E by its manufacturer. It will be available in 15-gm tubes that must be stored at 2° C to 8° C until dispensed. Patients should then store the tube in their refrigerator (up to 25° C). The product will be marketed in the United States by Bradley Pharmaceuticals, under license from MediGene AG, and should be available in the second half of 2007.
TIPS TO REMEMBER Veregen