Viagra Linked To 69 Deaths
The Food and Drug Administration says at least 69 Americans died after taking Viagra, the popular anti-impotence pill, but the agency continues to maintain that the drug is safe.
The agency said 66 of those who died were men and that the average age was 64 years. The cause of death was unknown in 21 cases, while 46 cases involved some sort of heart complication.
At least 12 victims took or were given nitrate medications, the FDA said. Nitrates are not supposed to be used with Viagra.
Viagra has been a huge hit for drug maker Pfizer since it won FDA approval in March. More than 3.6 million prescriptions have been written for the drug, which costs several dollars a dose.
Shares of Pfizer (PFE) fell almost $3 early Wednesday but later recovered and were up 1 3/16 to 107 11/16 in afternoon trading. Pfizer officials were not immediately available for comment.Altogether, the FDA has received reports of 123 deaths of people who obtained a prescription for Viagra. Twelve cases involved foreigners and 30 more could not be verified. In the remaining twelve cases, the agency couldn't confirm if the drug had actually been used.
Twenty-five (36 percent) of the 69 patients died or took on symptoms leading to death within four to five hours of drug use, including 18 during or immediately after sexual intercourse, the FDA said.
About three-quarters of those who died had some sort of heart problem or displayed characteristics, such as obesity, that could lead to heart trouble.
The FDA cautions that much of the information regarding the deaths is incomplete and inconclusive and stands by its view that the drug is safe if taken according to instructions.
"An accumulation of adverse event reports does not necessarily indicate that the adverse event was caused by the drug; rather, the event may be due to an underlying disease or some other factors," the agency said.
"As with all approved medications, the FDA will continue to monitor the postmarketing safety of Viagra by carefully reviewing reports of death and other serious advese events and will continue to evaluate the need for regulatory action," the agency said.
Since the drug went on sale, Pfizer has maintained that Viagra is safe. Indeed, many analysts expect European regulators to approve the drug soon.
Written By Jeffry Bartash