FDA Details Deaths of 16 Viagra Users

The fatalities ranged from the oldest man, an 80-year-old who collapsed suddenly in the middle of having sex, to the youngest, a 48-year-old, who experienced chest pains while having sex and later died in a hospital emergency room.

The Food and Drug Administration, aware of growing public attention to reports of men dying after using the popular impotence drug Viagra, released details of the known 16 cases Tuesday but continued to stress that there is no known direct link thus far between the drug and the deaths.

Seven of the 16 men died after having sex, and most of the men who died had been suffering from some underlying disease, including heart disease, high blood pressure or diabetes, the FDA said.

Many of the deaths were attributed to heart disease, although some of the men were taking–or had been administered–other medications known to be dangerous when used with Viagra.

The agency put out the brief descriptions in response to a Freedom of Information request, and said that the deaths at this time do not represent newly identified dangers related to the drug.

“We continue to believe the drug is safe, and people should talk to their health care providers about using it,” agency spokeswoman Lorrie McHugh said. “We expect we will continue to get ongoing reports, and we will monitor them.”

Viagra, sold by prescription and made by New York-based Pfizer Pharmaceuticals, has become wildly popular since receiving FDA approval in March.

At least 1.7 million prescriptions have been written for the drug, which works by relaxing muscles and allowing increased blood flow to certain areas of the penis, leading to an erection.

But Viagra can have life-threatening interactions with other drugs, specifically heart medications containing nitrates, such as nitroglycerin. Nine men died during the clinical trials of the drug.

Physicians and others repeatedly have pointed out that many of the men seeking Viagra are middle-aged or older, whose impotence is often the result of such ailments as heart disease and diabetes.

Some doctors have complained that men seeking Viagra have failed to reveal to them that they are taking other medications. Experts also have pointed out that the physical exertion involved in sex can put a considerable strain on the heart, especially for men who have not regularly engaged in it.

The FDA, emphasizing that in many instances the information was incomplete, released the following details:

* A 63-year-old man with a history of an irregular heart beat, diabetes and high cholesterol suffered a stroke about one hour after taking Viagra and having sex.

* A 62-year-old man on the heart drug digoxin, who also was taking insulin and blood pressure medication, took Viagra and about 30 minutes later–without engaging in sex–“his head dropped and he was no longer breathing.” The man, who had a history of diabetes, congestive heart failure and heart rhythm problems, was admitted to a hospital emergency room with no respiration or pulse. The cause of death was a heart attack.

* A 64-year-old man, taking Imdur, a nitrate, and having a history of heart disease and diabetes, “took one dose of Viagra, engaged in sexual activity and passed out.”

* A 60-year-old with an unknown medical history died after he was prescribed Viagra, but “it is not known if the patient took the medication.”

* A 73-year-old man with high blood pressure collapsed during sex after his second dose of Viagra. At the hospital, he was found to have suffered a stroke and a heart attack. “He did not regain consciousness and died.”

* A 73-year-old man with heart disease was hospitalized with chest pain and heart blockage and died a few hours after admission. There was no information regarding sexual activity.

* A 48-year-old man with a history of diabetes took Viagra, experienced chest pains during sex and was given nitroglycerin in an ambulance. “Chest pain subsided, and the patient was stable for 30 minutes. Chest pain began again and the patient went into cardiac arrest. He died in the emergency room.”

* A 74-year-old man on multiple medications and suffering from diabetes, high blood pressure and malignant melanoma died suddenly in the morning after an evening dose of Viagra.

* An 80-year-old with a chronic irregular heart beat “collapsed suddenly during sexual activity” and died.

* A 57-year-old man took a dose of Viagra, engaged in sexual activity and experienced severe chest pain immediately thereafter. He was given nitroglycerin and died in the hospital emergency room.

* A 70-year-old man with a history of heart disease “used Viagra and died at an unspecified date. No information regarding sexual activity.”

* A 67-year-old man on multiple drugs, with heart disease, high cholesterol and high blood pressure, died about 90 minutes after taking Viagra and having sex. “He turned a gray color and had breathing problems.”

The agency described the remaining four cases as coming from media reports.