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San Francisco health official seeks to make Viagra a controlled substance

San Francisco health official seeks to make Viagra a controlled substance

San Francisco's director of sexually transmitted disease control, Jeffrey Klausner, is petitioning the Food and Drug Administration to reclassify Viagra as a controlled substance, because he says the drug is commonly abused and has been linked with high rates of unprotected sex and STD transmissions, the San Francisco Chronicle reports. Klausner is requesting that the FDA reclassify Viagra as a Schedule III controlled substance, putting it in the same category as steroids and other drugs commonly abused, which would make prescriptions of the drug easier to track because of detailed reporting requirements by physicians and pharmacists. He also seeks a warning label on Viagra to state that it has been linked with higher risk for such STDs as syphilis and HIV. Klausner says label warnings--and possibly drug reclassification--also are needed for similar erectile dysfunction drugs Cialis and Levitra. Klausner says several studies have linked erectile dysfunction drugs with higher rates of risky sexual behavior, particularly among gay and bisexual men who may use the medications to have sex with multiple partners or to counter the effects of illegal drugs like crystal meth. A study presented by the San Francisco health department at the International AIDS Conference in Bangkok, Thailand, in July showed that Viagra users are twice as likely to be HIV-positive as nonusers. A 2002 study coauthored by Klausner also shows that 31% of gay men who engage in risky sex were taking Viagra that they had purchased illegally or without their doctor's knowledge. The FDA has 180 days to seek comment and rule on Klausner's request, which was filed with the agency as a citizen's petition on August 4 with the approval of the city's health department. Klausner has been trying to persuade FDA officials to add a warning to Viagra's label for the past two years. "While the FDA was not actively opposed to a label change, they were not making any effort to do anything about it,'' he told the Chronicle. "I met with them in February, and there was just no response.'' The National Coalition of Sexually Transmitted Disease Directors has sent a letter to the FDA in support of Klausner's proposal. Viagra maker Pfizer opposes Klausner's request, calling the petition filed with the FDA "grandstanding." Pfizer spokesman Daniel Watts says the company has been in talks with Klausner about his concerns and that the company has already agreed to prepare educational programs and a Web site to urge gay and bisexual men who use Viagra to talk with their doctors about the STD risks associated with unprotected sex.

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