Viagra, Heart Attacks: What's The Bottom Line?

Debate Renewed Over Which Men With Heart Ailment Should Avoid Sex Drug

By Tony Cappasso, Contributing Writer
June 23, 2000, 2:59 p.m. EDT

Men under treatment for certain types of heart disease have already been warned that using Viagra increases their risk of heart attack. But now some researchers are arguing that the "risky" category should be broadened to warn more people off the drug, which is intended to help men who suffer from "erectile dysfunction," or impotence.

Conflicting views were presented at a recent meeting of the American College of Cardiologists.

A research team from Cedars-Sinai Medical Center examined reports of bad side effects from Viagra collected by the Food and Drug Administration in its "adverse event reporting system." In an analysis of 1,473 reported major adverse events, 522 people died -- the majority of cardiovascular causes, according to the researchers.

• The majority of deaths -- 70 percent -- were associated with the standard Viagra dosage, 50 milligrams, and were attributed to cardiovascular causes.
• In two-thirds of the deaths, the victim had taken Viagra within four to five hours before the death was reported.
• The majority of deaths occurred in men who were younger than 65 and who had no reported heart disease risk factors.

Don't Blame The Nitrates?

What was at issue, though, was the role of nitrates -- drugs taken by people with chest pain or angina.

The Cedars-Sinai study confirmed the well-documented increase in heart risks when nitrate use is combined with Viagra. Of the 90 patients who were on nitrates and taking Viagra, 68 percent died, and another 20 percent suffered non-fatal heart attacks. Viagra's manufacturer, Pfizer, officially discourages mixing Viagra and organic nitrates such as nitroglycerin.

Is that the culprit? Other researchers tended to confirm that view at the American College of Cardiologists meeting. Researchers from Sweden told the group that Viagra is safe for men with cardiovascular disease as long as they are not taking nitrates.

However, the Cedars-Sinai study showed that of the deaths recorded by the FDA, a whopping 88 percent occurred in patients who were not taking nitrates.

That led investigators to speculate that there are some individuals who are susceptible to harmful effects of Viagra without nitrates.

Sound Familiar?

It's not the first time that the heart-risk worry has been raised -- and put back down again -- since Viagra was approved in late March 1998.

Within a few months, the FDA said that most Viagra users who died had died of cardiovascular ills. In August 1998, major cardiology associations in the U.S. issued a warning about combining Viagra with nitrates. The next month, European researchers called for more testing after a 65-year-old man in the Netherlands suffered a heart attack shortly after ingesting the drug.

Experts speculated about a possible physical reaction that could explain a link. Pfizer at the time said Viagra users' deaths from heart attacks or strokes could be related to other cardiovascular risk factors or the exertion of renewed sexual activity.

In November 1998, the FDA and Pfizer changed the drug's warning label to say that Viagra should be used with caution by people with high blood pressure, unstable angina or retinitis pigmentosa, as well as those who had recently suffered a heart attack, stroke or life-threatening arrhythmia.

In January 1999, the U.S. cardiology associations issued a broader list of cardiovascular conditions that would make taking Viagra risky.

But in May 1999, University of Florida researchers tried to calm worries, saying there was "no solid scientific evidence that patients with cardiovascular disease face a higher risk of death when they take Viagra. Still, the researchers urged intensive study of the theoretical connection.

The recent debate shows that the medical establishment needs to work for greater consensus on whether risk factors for Viagra extend beyond nitrates.

Related Links:

• Health News, March 14, 2000: Viagra Linked To Cardiovascular Problems
• From Channel 6000, March 15, 2000: Does Viagra Hurt Your Heart?

From the American Heart Association:

• August 1998: Summary Statement on the Use of Sildenafil (Viagra ™) in Patients at Risk of Cardiovascular Effects
• Quiz: Are you at risk for heart attack or stroke?
• What’s the risk? Sexual activity and heart disease or stroke

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