Viagra Linked to 522 Deaths
March 14, 2000 (Anaheim, Calif.) -- New research shows that 522 patients have died while taking Viagra (sildenafil) in the first year the drug was on the market. Since its introduction in March of 1998, more than 12 million prescriptions of the blockbuster treatment for erectile dysfunction (ED) have been written. There are continued concerns that the drug could trigger heart problems in some users; already it is not recommended for patients taking nitrates for this reason.
"Our data appear to suggest that there's a relatively high number of deaths and adverse cardiovascular events associated with the use of Viagra. I want to emphasize that in no way are we trying to imply a cause-and-effect relationship," lead researcher Sanjay Kaul, MD, a critical care cardiologist at Cedars-Sinai Medical Center in Los Angeles, tells WebMD. Kaul presented his findings here Tuesday at the 49th Annual Scientific Session of the American College of Cardiology.
Kaul got his numbers by lodging a Freedom of Information Act request with the FDA. Overall, he found 1,473 major adverse events in the agency's surveillance database related to Viagra. For instance, in addition to the 522 deaths, Kaul noted 517 patients who experienced heart attack or anginal chest pain when using the drug.
However, it's difficult to interpret the data without comparing them to a similar population not taking the drug, and that's why Kaul says that additional research is necessary. In the meantime, he says there's no reason to panic.
"The most important message is that in most patients at low risk, Viagra is generally safe. However, you need to evaluate the patient's cardiac risk before you prescribe Viagra," says Kaul.
Meanwhile, another Viagra study presented here Tuesday came to a very different conclusion. This research, done in collaboration with Pfizer, Viagra's manufacturer, compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn't any real difference between the groups.
"It's reassuring that ... in general, for most patients, even those with existing coronary [heart] disease ... resuming sexual activity is very unlikely to trigger a [coronary] event," says lead researcher Murray A. Mittleman, MD, an internist and preventive cardiologist at Beth Israel Deaconess Medical Center in Boston.
Mittleman says that the FDA database is better at spotting unusual events than seeing aberrations in common conditions like heart attacks. However, the agency concedes that drug problems are drastically underreported, with perhaps only one in 10 eventually getting the FDA's attention.
"Our data appear to suggest that there's a relatively high number of deaths and adverse cardiovascular events associated with the use of Viagra. I want to emphasize that in no way are we trying to imply a cause-and-effect relationship," lead researcher Sanjay Kaul, MD, a critical care cardiologist at Cedars-Sinai Medical Center in Los Angeles, tells WebMD. Kaul presented his findings here Tuesday at the 49th Annual Scientific Session of the American College of Cardiology.
Kaul got his numbers by lodging a Freedom of Information Act request with the FDA. Overall, he found 1,473 major adverse events in the agency's surveillance database related to Viagra. For instance, in addition to the 522 deaths, Kaul noted 517 patients who experienced heart attack or anginal chest pain when using the drug.
However, it's difficult to interpret the data without comparing them to a similar population not taking the drug, and that's why Kaul says that additional research is necessary. In the meantime, he says there's no reason to panic.
"The most important message is that in most patients at low risk, Viagra is generally safe. However, you need to evaluate the patient's cardiac risk before you prescribe Viagra," says Kaul.
Meanwhile, another Viagra study presented here Tuesday came to a very different conclusion. This research, done in collaboration with Pfizer, Viagra's manufacturer, compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn't any real difference between the groups.
"It's reassuring that ... in general, for most patients, even those with existing coronary [heart] disease ... resuming sexual activity is very unlikely to trigger a [coronary] event," says lead researcher Murray A. Mittleman, MD, an internist and preventive cardiologist at Beth Israel Deaconess Medical Center in Boston.
Mittleman says that the FDA database is better at spotting unusual events than seeing aberrations in common conditions like heart attacks. However, the agency concedes that drug problems are drastically underreported, with perhaps only one in 10 eventually getting the FDA's attention.
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