WASHINGTON -- Nearly three months after approving Viagra, the Food and Drug Administration had received about 100 reports of men suffering serious adverse reactions or dying after taking the impotence drug, but regulators remain convinced Viagra is safe.
Altogether, as of mid-June, the FDA had received about 30 reports of men dying after taking Pfizer Inc.'s blockbuster impotence drug. Most were elderly, with other health problems. In addition to the deaths, the reports show seven men had heart attacks, eight suffered strokes, four blacked out and six had vision problems, according to government reports obtained through the Freedom of Information Act.
The reports, however, probably cover only a fraction of the cases of serious side effects suffered by the two million men who have used Viagra since it hit the market in April. The government doesn't require reports on serious adverse reactions, and public-health experts figure that the FDA typically receives reports on only 1% to 10% of these reactions. Rather than track all reactions, the government searches for signals that a drug may cause unusual effects on patients, which it says it can detect from just one or two cases.
Specialists Study Reports
The FDA has convened a team of about seven specialists to study the reports on Viagra, but has found no signals that anything unusual had occurred, said Dr. Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research.
It is clear that Viagra shouldn't be mixed with nitrates, a warning Pfizer puts on the drug's label. Still, several men have died after mixing Viagra and nitrates.
But the latest reports raise questions about whether other drugs should be taken with Viagra, said Dr. Raymond Woosley, chairman of Georgetown University's pharmacology department. "All high-blood-pressure medications are suspect," he said, since Viagra can lower blood pressure, causing a potentially dangerous drop in pressure, he said. According to the reports, at least 14 people were taking some kind of blood-pressure medication when they took Viagra, including at least four who died, three who blacked out and two who developed vision problems.
Although Pfizer's package insert states that blood-pressure medications were tested and could safely be taken with Viagra, Dr. Woosley said the numbers in the study may have been so small that the company couldn't detect any reactions. He also raised concerns about taking Viagra with Glucatrol, a diabetes drug. At least five patients taking Viagra and Glucatrol or a similar drug have had bad reactions. Two died.
Multiple Medications
To be sure, many of the patients who had adverse effects had a variety of diseases and were on multiple medications; without further study, it would be impossible to explain why they had bad reactions. One stroke victim was taking Viagra and 11 other medications.
Some of the reports sound serious but provide so little information that it is impossible to tell whether the reactions cited actually occurred. Also, some of the reports may be duplicates. Pfizer received reports that four men in West Virginia went blind after taking the drug, but Pfizer spokesman Andy McCormick said the reports came from one salesman who heard it from an osteopath, who heard about the men. The company, which is required to forward all reports of serious reactions to the FDA, couldn't find more information about the situation.
Several ophthalmologists said that the vision reactions reported to the FDA aren't cause for alarm.
-- Otesa Middleton in Washington and Robert Langreth in New York contributed to this article.
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