On August 5, 2004, the San Francisco Department of Public Health, STD Prevention Section, exercised its right to file a Citizen Petition to the Food and Drug Administration asking that the FDA take action to reduce the risks associated with Viagra use.
City public health officials have since been encouraging researchers, physicians and other public health experts to submit written testimony during the FDA’s 180-day comment period.
The move comes after years of trying to convince the FDA and industry to address the problems of Viagra abuse. Multiple research studies have demonstrated that Viagra is commonly used outside of medical supervision for purposes not medically indicated. In some populations, its use is associated with increased risk for sexually transmitted diseases (STDs), including HIV infection. Since 2001, the STD Section has reported hundreds of cases of new STDs and HIV infections in Viagra users to the FDA.
Jeffrey D. Klausner, MD, MPH, Director of San Francisco’s STD Prevention Section, who filed the petition on behalf of the Department of Public Health, has been The City’s leading voice in bringing the topic of recreational Viagra use before the industry and the public. “We are requesting that the FDA take action to reduce the problem of Viagra abuse and the subsequent risk for STDs, including HIV infection. One such action is to change the labeling of Viagra and other drugs in its class to specifically state that, ‘Viagra use may increase the risk for sexually transmitted diseases and HIV infection.’ Additionally, the FDA should encourage doctors and patients to talk about risk reduction, including condom use with new or multiple partners.”