NEW YORK -- Pfizer Inc., seeking to allay concerns about its blockbuster impotence medication Viagra, said the deaths of six men taking the drug resulted from known risks of increased cardiac stress related to sex or of combining the drug with nitrate medications.
Pfizer said it concluded that three of the deaths were cardiovascular -- heart attack or stroke -- following sexual activity, while the others were attributed to the combination of Viagra and nitrates. Nitrate medications, such as nitroglycerin, are often used to treat chest pain in heart patients.
Pfizer said it is making no changes to the drug's label as a result of its findings. The label currently warns against combining Viagra with nitrates. It mentions the increased cardiac risk associated with sex and advises physicians to consider the cardiovascular health of their patients before prescribing the drug.
Pfizer reported the six deaths to the Food and Drug Administration in recent weeks.
At least some of the six men had serious conditions such as diabetes or high blood pressure and the three men whose deaths were cardiovascular were over the age of 60, a Pfizer spokeswoman said.
In a statement, the company said: "Pfizer believes that the information available in the cases does not suggest any risk to patients which is not already described in the product label or known for the population being treated with Viagra."
While sexual activity does increase the risk of a heart attack for those taking the drug, that risk is still relatively low, experts say. But they stressed that men with a history of heart problems, especially if they are sedentary, should consult their physicians before resuming sexual activity.
More than a million men have filled prescriptions for Viagra since the drug was approved March 27.
Pfizer refused to discuss the specific circumstances of any of the deaths. It also left open the question of whether the deadly combination of Viagra and nitrates resulted from a doctor inappropriately prescribing Viagra for a patient on a nitrate medication, or whether emergency room doctors or paramedics might have administered nitrates to a patient complaining of chest pain without first ascertaining whether the patient was on Viagra.
An FDA spokeswoman said the agency hasn't identified a direct link between Viagra and the reported deaths and continues to believe the drug is safe and effective. The FDA currently has no plans to change the drug's safety profile, she said. "We will continue to monitor these and other reports we receive," she said.
Experts say the reported deaths come as no surprise, because men taking Viagra tend to be older and often have serious conditions such as heart disease or diabetes. About 85% of men taking Viagra are over the age of 50, according to Pfizer.
Nevertheless, the advent of Viagra has put some men at increased risk of heart attack simply by enabling them to resume sexual activity they were forced to abandon by heart disease, diabetes and other conditions that left them impotent, experts say.
Meanwhile, the University of Florida Health Science Center in Jacksonville is looking into the death of a Florida man who went into cardiac arrest shortly after taking Viagra, according to David Vukich, the hospital's chief of emergency medicine.
The man, in his 50s and with a history of serious heart disease, collapsed during intercourse and was brought to the emergency room this month. He had been taking heart and blood-pressure medications but wasn't on nitrates, Dr. Vukich said.
The hospital will decide whether the death should be reported to Pfizer. The FDA requires drug makers to report serious or unexpected adverse events of patients on the drug to the FDA within 15 days of its learning about them. Pfizer says it got news of the six deaths from doctors, hospitals and its sales representatives.
Cardiologists said it is unlikely the reports of the death will -- or should -- discourage most men from taking Viagra to treat impotence problems.
Although sexual activity nearly triples the risk of a heart attack for a 50-year-old man with a history of heart disease, that risk is still less than 30 in a million compared with a baseline risk of 10 in a million, says James Muller, director of the Gill Heart Institute of the University of Kentucky Medical Center in Lexington, Ky.
"Cardiac patients have to weigh that against the desirability of having sex," Dr. Muller says. "My guess is almost everyone will decide in favor of sexual activity." A 50-year-old healthy man has a baseline risk of heart attack of one in a million, a risk that goes up to 2.5 in a million as a result of sexual activity.
Pfizer has moved aggressively to hammer home safety warnings about Viagra. Last week, the company reissued guidelines that reiterated the cardiovascular risk related to sex as well as the warning about nitrates. The company has issued warning letters about combining Viagra and nitrates to 21,000 emergency room doctors and plans to send similar letters to emergency room nurses and paramedics.
-- Robert Langreth and Rochelle Sharpe contributed to this article.
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