Following article states that 20 out of one million men have heart attacks associated with sex. With this drug, there are more men and older men with a higher risk of heart attacks.
Paper: Houston Chronicle
Date: SAT 05/23/98
Section: A
Page: 10
Edition: 3 STAR
Feds, Viagra's maker report deaths of six men who tookdrug
By JOHN SCHWARTZ
Washington Post
Six men have died after using Viagra since the popular impotence drug hit the market, federal regulators and the drug's manufacturer said Friday.
The causes of the deaths are still under investigation, and the drug's maker, Pfizer , declined to elaborate. While the deaths could prove to be unrelated to the drug, the new reports raised concerns that Viagra could be interacting with other medications, or is allowing men with pre-existing heart conditions to overexert themselves through sexual activity and bring on heart attacks.
Since the Food and Drug Administration approved Viagra in April, more than 900,000 users have received prescriptions, according to market research firm IMS America Ltd. - making Viagra the biggest launch of a new drug in recent years.
This week, Pfizer sent a letter to doctors reiterating some of the health warnings that it published at the time of the drug's approval.
Because "sexual activity generally involves an increase in cardiac work and myocardial oxygen demand," the company stated, physicians should evaluate the heart health of patients before prescribing the drug. Cardiovascular disease is the leading cause of impotence and could create health complications for users.
Pfizer also warned emergency room doctors to ask heart patients if they are taking Viagra before administering drugs that might cause a drop in blood pressure, such as the heart medicine nitroglycerin.
Because Viagra can depress blood pressure, the combination can cause dangerously low levels. Doctors also were advised to look for complications arising from Viagra's use with such drugs as amyl nitrate, which also lowers blood pressure.
"Overall, the experience to date is consistent with everything we know about Viagra," said Pfizer spokesman Andy McCormick - "that is, it's safe and effective medication." Joseph Feczko, Pfizer 's top drug safety official, said the complications reported so far are "lower than we'd expect, based on the number of prescriptions," and said the figures this far "give us a reassuring feeling."
FDA spokeswoman Lorrie McHugh said that the agency is investigating the deaths, but officials "continue to believe that the drug is safe and effective for its indications and the intended patient population."
However, doctors have been prescribing Viagra for users who do not fall within that ideal patient population - that is, men with impotence problems who have been screened for cardiovascular disease, or who are taking nitrates. Once a drug is approved for one use, doctors are free to prescribe it freely.
The risk of heart attack from having sex is generally low - only about about 20 cases per million, just 2 1/2 times greater than the baseline level of risk in daily life, said James Muller, a director of the Gill Heart Institute at the University of Kentucky.
But if a patient's impotence is caused by undiagnosed heart disease and he does not normally exercise, and if the newly regained sexual ability leads him to exert himself strenuously, Muller said, the risk could become significant.
"My guess is they'll have a one in a thousand risk of heart attack," he added.
Heart attack is "a predictable result" of using Viagra for that class of men, said James Barada, of the Center for Male Sexual Health in Albany, N.Y. Other doctors have told him about prescribing the drug over the phone, Barada said.
"I do not give Viagra unless they see me face to face" so that he can discuss the underlying disease issues, he said. |
