VIAGRA: FDA Says 16 Men Have Died While Taking The Pill

      Sixteen men have died while taking Pfizer's wildly popular impotence drug Viagra since it was approved by the Food and Drug Administration in March, but FDA officials say "there is no known direct link thus far between the drug and the deaths." The FDA released descriptions of the deaths yesterday, but the Los Angeles Times reports that the agency stressed that it is not concerned about new dangers associated with the drug. "We continue to believe the drug is safe, and people should talk to their health care providers about using it," said FDA spokesperson Lorrie McHugh. "We expect we will continue to get ongoing reports, and we will monitor them" (Cimons, 6/10). Seven of the men died during or after Viagra-aided sexual activity. Nine of the men "already had heart disease," AP/USA Today reports. While the FDA emphasized that Viagra is not dangerous, it reiterated warnings that mixing the impotence pill with the heart disease medication nitroglycerin "can be deadly." Two of the cases reported yesterday suggest that the combination could have been a factor in the deaths (Neergaard, 6/10).

Stand By Your Drug
      Pfizer officials are "not alarmed" by the reported deaths associated with their blockbuster drug, which has been prescribed to 1.7 million men since it was introduced commercially (Vedantam/Uhlman, Philadelphia Inquirer, 6/10). "We concur in (the FDA's) position that the drug is safe and effective if used properly," said Pfizer spokesperson Andrew McCormick. He said the manufacturer will join the FDA in looking "to see if there's something about the drug that's unknown that could be contributing to any strange side effect" (Sisk, New York Daily News, 6/10).

To Make Matters Worse
      In addition to the nine men with a history of heart disease, the Wall Street Journal reports that seven of the men who died while on Viagra "had blood pressure problems and five were diabetic" (Sharpe, 6/10). The popularity of Viagra has "led to concern that some patients at high risk may be getting" the drug, the Inquirer reports. And that could be dangerous -- "[t]he pill can fool men with heart problems into believing they are fine." A man with heart disease who refrains from sexual activity "may have 'built in' a defacto protective mechanism by not overstressing his heart," said cardiothoracic surgeon Andrew Wechsler of Allegheny University of the Health Sciences. Wechsler urges men to have a thorough physical before taking the impotence drug. But Director of the University of Pennsylvania's Center for Male Sexual Dysfunction Gregory Broderick emphasizes that "doctors don't have any way of figuring out exactly who's going to keel over during sex" (6/10).

Testing 1-2-3
      An article in today's Wall Street Journal "Marketplace" section asks: "What if Viagra is hazardous when taken with other medications, which Pfizer and the FDA have yet to identify?" The Journal reports that in several of the 16 deaths reported yesterday, patients were taking drugs that "hadn't been formally tested with Viagra in human trials." Experts say the "astounding launch" of Viagra "makes the emergence of unforeseen side effects and drug interactions ... inevitable." Georgetown University Medical Center Chief of Pharmacology Raymond Woolsley said: "Just because the FDA says a drug is safe and effective, don't be surprised when problems crop up" (Jeffrey/Langreth, 6/10).

Dishing It Out
      Alan Greenberg, chair of Bear, Stearns Companies, pledged $1 million yesterday to provide "Viagra prescriptions for people who cannot afford them," the New York Times reports. "I guess you could say I'm kind of into basics," he said. "And I think it's something that will give a lot of pleasure to a lot of people." Greenberg said he decided to donate the money after reading articles about the debate over covering the impotence drug under state health programs and some insurance plans (Fisher, 6/10).

Drug Mix
      The Wall Street Journal looks at drug safety in light of the announcement by Roche Holdings AG that it would withdraw Posicor, its "popular hypertension drug" introduced 10 months ago, because of "potentially adverse interactions with two dozen other medications." While Roche did test the drug for interactions with other popular medications, "[t]he company contends that it is simply impossible to test for everything before a drug is approved." However, some experts argue that drug companies need to conduct more extensive testing for drug interactions. Biostatistician Lemuel Moye, one of three dissenting members on the FDA advisory panel that recommended approval of Posicor, said, "There's a stampede for efficiency in getting drugs approved, and it may be getting in the way of safety." Public Citizen's Dr. Sidney Wolfe agreed that Posicor should not have been approved without additional studies. He said, "There were a lot of safety problems, and there was no evidence it was better than other drugs for high blood pressure." However, Robert Pordy, director of clinical research for Roche's Hoffman-LaRoche unit, argued that "[n]o company could study the whole myriad of other medicines for possible drug interactions." He said, "We studied the drugs that were most likely to have interactions or were most commonly used," adding that it is very difficult to answer questions as to "whether the problems could have been predicted (Langreth, 6/10).