By John Schwartz
Washington Post Staff Writer
Friday, May 29, 1998; Page A02

Case No. 4 took Viagra on April 28. The impotence drug had the desired effect -- before long he was able to have sexual intercourse. But during the act, something went terribly wrong for the 73-year-old man: He collapsed. After he was taken to the hospital, doctors found that the man had suffered both a heart attack and a stroke. "He never regained consciousness and died."

So reads one of six cases reported to the Food and Drug Administration by Viagra's maker, Pfizer Inc., and physicians describing deaths possibly associated with the popular drug. The deaths were announced late last week, and the FDA made the reports available to The Washington Post in response to a Freedom of Information Act request. Such reports are required by law. The agency did not release the names or locations of patients and doctors.

A senior FDA official noted that only four of the deaths described in the reports clearly occurred after individuals took the drug. That number is too small to draw any conclusions, especially because about 1 million prescriptions for the drug have been filled since it went on the market, the official said.

"This does not seem to represent a trend or a signal or something worrisome to us at this point," said the official, who asked not to be identified. The official added, however, that the agency expects to receive more reports over time -- in part because of news media attention to the drug. "We will continue our ongoing monitoring" to "see if something begins to say there is a signal here. Based on what we've got here, we're not at that point," the official said.

Nine patients taking Viagra died during clinical trials, compared to one patient who took a fake pill as part of the test and died of a self-inflicted gunshot wound. The company and the agency determined that those deaths were "plausibly not related" to the drug.

The FDA approved the drug for use by many of the 30 million Americans who suffer from impotence, with a warning that it should not be used by patients taking heart drugs known as nitrates, which in combination with Viagra can drive blood pressure down to dangerously low levels. The company and the FDA warned doctors and patients to look for evidence of cardiovascular or other health problems that might pose a threat to patients' health if they overexert themselves.

The reports to the FDA are mixed. Some provide full descriptions of the patient's physical condition and treatment, describing patients with prior cardiovascular disease, diabetes, high blood pressure or a combination of the three. Case No. 5, on the other hand, simply states that a patient died after receiving a Viagra prescription, but does not say whether he used it or why he died. Case No. 6 recounts that a pharmacist "heard from a customer that 1 male patient died while taking viagra. . . . The customer's source of this report is a television show (Jay Leno)."

In case No. 3, a 62-year-old man was admitted to a hospital emergency room "DOA" -- dead on arrival. He was taking medications for diabetes and high blood pressure. According to the sketchy handwritten report, the man's wife said he became ill about an hour after taking his first dose of the drug. "In car on way to town, his head suddenly dropped & he was no longer breathing and was slobbering/drooling. On arrival No respiration, No Pulse."

In a statement released yesterday, Pfizer said that after reviewing the deaths of patients, the company had no plans to change the drug's label. "The information available in the cases does not suggest any risk to patients" that the company has not already warned patients and doctors about, the company said. It appears, the company said, that the cases "were attributed to either cardiovascular events associated with sexual activity in older men" or patients taking Viagra along with nitrates.

Many patients who might want the drug may have the undiagnosed medical problems that put them at risk, according to Randall M. Zusman, associate professor of medicine at Harvard Medical School.

"The patients who are very likely candidates for therapy and have the risk factors for erectile dysfunction are the same patients who are at the most risk for having an event" such as heart attack or stroke, he said. But Zusman, who has served as an adviser to Pfizer on Viagra, said that the drug "certainly can be used safely by the vast majority of patients."

The senior FDA official said that if a pattern does emerge from Viagra reports over time, it is less likely to show a side effect than a foreseeable risk. He compared the situation to that of a person with arthritis who takes an anti-inflammatory drug. What if, the official asked, the person's joints stop hurting and "they go out and shovel snow, so that they have a heart attack. Did the drug cause the heart attack?"