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FDA: Deaths likely not linked to Viagra

graphic May 22, 1998
Web posted at: 7:16 p.m. EDT (2316 GMT)

WASHINGTON (CNN) -- Six men taking the new impotence drug Viagra have died, but the Food and Drug Administration says there is no reason to believe that the deaths are linked to the drug.

The FDA routinely requires the makers of all newly approved drugs to file reports of any deaths among users. Pfizer Inc., which makes Viagra, reported the six deaths among more than a million men who have taken the drug.

About 85 percent of the men taking Viagra are between the ages of 50 and 70 and many suffer from serious medical problems that are the underlying cause of their impotence.

"We are going to look into these reports as we do all adverse reports," said FDA spokeswoman Lorrie McHugh. "We continue to believe that the drug is safe and effective for its indications and the patient population."

In clinical trials of Viagra, which involved only a few thousand men, eight deaths were reported. None of those was attributed to the use of the drug.

"Pfizer maintains that this is an effective and safe medicine when used appropriately in men who have diagnosed erectile dysfunction," said company spokeswoman Mariann Caprino. "Men with erectile dysfunction tend to be older and frequently suffer from serious underlying medical conditions, ranging from diabetes to hypertension to cardiovascular disease."

However, in the wake of the reports, the FDA has asked Pfizer to reiterate safety information to Viagra patients in order to make sure the drug is being used properly.

The company advises that Viagra only be taken by men who have erectile dysfunction diagnosed by a doctor after a medical exam. It also notes that sexual activity among older patients with known heart disease can be risky, which their doctors should take into consideration.

The FDA has warned since approving the drug in March that it is dangerous to take Viagra together with nitroglycerin or related heart drugs. Such a warning appears on the drug's label.

Reuters contributed to this report.

 
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