May 23, 1998
Viagra Not Yet Linked to Deaths of 6 Users
By GINA KOLATA
ix people taking the impotence drug Viagra have died, the drug's maker and the Food and Drug Administration say. But, the FDA said, it has no information linking -- or not linking -- the deaths to the drug.
The deaths were revealed on Thursday after Pfizer Inc., the maker of Viagra, began getting calls from news organizations asking whether any people taking Viagra had died or had been seriously injured.
Andy McCormick, a Pfizer spokesman, said that there had been news reports that some men taking Viagra and the heart medicine nitroglycerin had died but that he was unable to give any details of any deaths. The drug's warning label says it is not to be used with nitroglycerin or similar drugs used to treat the chest pains of heart disease. The danger is that Viagra and nitroglycerin combined can make the blood pressure plunge to a dangerously low level.
But, of course, patients taking nitroglycerin have serious heart disease, so even if such patients died while taking Viagra that in itself would not mean that they died because they took Viagra.
McCormick said that a million prescriptions for Viagra have been written since the drug was approved in March and that 85 percent of the prescriptions were for men aged 50 and older, many of whom have other medical conditions, like heart disease. He said that the company was concerned that some people taking the drug might not have gotten it from a doctor or might not have known about the danger of taking it and nitroglycerin.
And so, McCormick said, on Thursday morning, Pfizer put out a press release reiterating the danger of taking its drug with nitroglycerin and related heart drugs, and specifically warning emergency room workers to be aware of the possible interaction of the drugs.
That same day, news organizations began asking the FDA and Pfizer how many people taking Viagra had died. In response, said Laurie McHaugh, a spokeswoman for the FDA, the agency asked Pfizer to summarize what it knew. Companies are required to report deaths or unexpected adverse events to the FDA within 15 days of learning about them, Ms. McHaugh said. Pfizer had been sending reports to the agency, Ms. McHaugh added. Pfizer said it had heard of six deaths.
McCormick said that the company followed the FDA's reporting regulations and that it was not Pfizer's practice to release details of deaths or adverse reactions to the public.
"We can't characterize anything about the events or the situation," McCormick said. But, he added, "Everything we've seen says that the safety and efficacy that the FDA approved the drug for remains consistent."
Ms. McHaugh said the FDA would "be looking into those deaths and other serious adverse-events reports, as we do with any drug." She added: "The FDA continues to believe that the drug is safe and effective for its labeled indication and intended patient population."