California Health Officials Ask FDA to Warn Consumers on Viagra, Gonorrhea Transmission Link

San Francisco public health officials have asked the FDA to change the warning label of Viagra to indicate that the impotence drug is linked to gonorrhea transmission, the Los Angeles Times reports. Dr. Jeffrey Klausner, director of sexually transmitted disease control for the city, said that the use of Viagra leads to risky sexual behavior and therefore a greater likelihood of STD transmission, not that Viagra directly causes gonorrhea. Klausner has asked the FDA to include a warning specific to gonorrhea because the infection is more common than other STDs among men who have sex with men and is "far more infectious" than other diseases. His "unusual appeal" to the FDA comes after he led a study of 844 men at San Francisco's STD clinic that found men who have sex with men were more than four times more likely to use Viagra than heterosexual men. Klausner also said that young men who have sex with men often use Viagra as a recreational drug along with ecstacy and other illegal drugs, a combination that "lessen[s] their resolve to use condoms." The study, to be published in an upcoming issue of the journal AIDS, found that 43% of the 108 Viagra users mixed the drug with ecstasy and 28% took it with methamphetamines. In addition, nearly 33% of gay and bisexual users had at least one STD at the time of the study, compared to 23% of non-Viagra users. Finally, Viagra users averaged 5.4 sexual partners in the prior two months, compared to 3.5 partners for non-users. "The data's clear, the evidence is strong," Klausner said, adding, "There's really at this point no excuse for inaction by the FDA" or Pfizer, the drug's manufacturer. FDA spokesperson Laura Bradbard, however, said that the agency will wait until further studies are conducted on the issue before it decides whether to order a warning label change.

'Beyond Our Control'
A Pfizer spokesperson said the company believes that the issue of STD transmission is adequately addressed by Viagra's current warning label, which reads: "Viagra does not protect you or your partner from getting sexually transmitted diseases, including HIV -- the virus that causes AIDS." Pfizer spokesperson Geoff Cook said, "Nobody should think that by taking Viagra they can be protected," adding, "Clearly they need to engage in safe sex." Pfizer, in fact, has warned doctors that mixing Viagra with amyl nitrate -- known as "poppers" -- can cause a dangerous drop in blood pressure. Cook noted that "any pharmaceutical product can be abused, and that's beyond our control." However, Klausner hopes to match his successful appeal to the FDA last year to force drug makers to "tone down" ads for HIV drugs that downplayed side effects and the consequences of the disease, the Times reports. Dr. Peter Kerndt, director of STD control for Los Angeles County, agreed with Klausner's push for a warning label, saying that he has also noted recreational use of Viagra in the gay community. However, gay and bisexual men have met Klausner's Viagra warning label proposal with skepticism, the Times reports. Kevin Hunt, a 29-year-old financial analyst in San Francisco, said that he mixed Viagra with crystal meth in order to counteract the erection-inhibiting effect of the latter. "Let's place blame where it lies. It's not fair to target a pharmaceutical company because people find a legal method to cope with an illegal problem," he said (Ornstein, Los Angeles Times, 3/15).