 |
Year
2007 |
|
Archives
|
|
|
Call for FDA to address Viagra abuse
Posted By: News-Medical in Pharmaceutical News
Published: Monday, 23-Aug-2004
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.”
While Dr. Klausner has in the past called on the industry to educate doctors and the public about the risks associated with Viagra use, Pfizer, the maker of Viagra, has responded with plans for a general education campaign about patient-doctor communication. Klausner wants manufacturers to specifically address the issue of recreational Viagra use, use of Viagra with other drugs such as methamphetamine and widespread abuse among younger men and men who have sex with men.
“It is mind boggling that a patient could request Viagra, a doctor prescribe it and there be silence about sexual activity or sexual risk behavior. This is irresponsible and must change,” Klausner observed.
Exacerbating the problem has been a shift in the marketing of these drugs from elder statesmen such as Bob Dole, to young sports heroes or vibrant, attractive men strolling through an office. Manufacturers are clearly selling sexual performance, which goes beyond the approved indication of the drug.
Mark Kleiman, MD, Professor of Policy Studies at UCLA School of Public Policy and Research and Editor of the Drug Policy Analysis Bulletin, has suggested that one way to reduce the misuse of Viagra is to make it a controlled substance—a move the Department may pursue. source :-http://www.news-medical.net/ | 
