Bateman and all, the perspective of an epidemiologist who specializes in population death rates (scroll down):
Friday May 22 4:22 PM EDT
FDA, Pfizer investigate deaths in Viagra men
By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - Six men have died after taking the blockbuster impotence pill Viagra, but it is not clear whether any of the deaths were caused by the drug, the Food and Drug Administration said Friday.
The FDA said it and Pfizer, the makers of the drug, were investigating the causes of the deaths. But Pfizer pointed out that more than a million people, most of them middle-aged, have been prescribed
the drug.
FDA spokeswoman Laurie McHugh said the FDA called Pfizer on Thursday to ask how many men had died after taking Viagra, which has been on the market since April. "They reported to us that they had learned of six deaths of people taking Viagra," she said.
"We are going to look into these reports as we do all adverse reports," she said. "We continue to believe that the drug is safe and effective for its indications and the patient population."
An epidemiologist who specializes in population death rates said nothing could be concluded from the numbers.
"With six deaths in six weeks, that is totally meaningless," said Dr. Javier Nieto of the Johns Hopkins University School of Public Health.
"I wouldn't pay any attention, because all these six men also had breakfast those days. (This figure) doesn't tell me much. I am sure more than six died in those weeks."
In fact, according to the most recent statistics on deaths among men from the National Center for Health Statistics, 335 deaths from all causes could be expected in any given week among one million men aged between 45 and 74.
According to the Center, more than 500,000 men in that age group died in 1996 from all causes.
The FDA and Pfizer will investigate whether the deaths can be linked to Viagra.
The drug's label clearly states that it should not be taken by men who are also taking nitroglycerin or other nitrate drugs prescribed for heart disease, and Pfizer has made this clear in its advertising. On Thursday Pfizer reiterated those warnings, saying it was appropriate to do so given the huge amounts of attention the drug has received.
"There are over a million men who have taken the drug," Pfizer spokeswoman Mariann Caprino said in a telephone interview.
In the clinical trials, which involved only a few thousand men, eight deaths were reported. None was attributed to use of Viagra.
"Pfizer maintains that this is an effective and safe medicine when used appropriately in men who have diagnosed erectile dysfunction," Caprino added. "Men with erectile dysfunction tend to be older and frequently suffer from serious underlying medical conditions ranging from diabetes to hypertension to cardiovascular disease."
She noted the drug did require a prescription and that men had been urged to go to specialists who would take a careful health history before prescribing the drug. "It is not something that can be prescribed over the Internet," she said.
Pfizer said it estimated about 85 percent of the men who had been prescribed Viagra were between the ages of 50 and 70. "Obviously we are vigilantly monitoring all severe adverse events including deaths," Caprino said.
Drug companies, and the FDA, always expect more side-effects and adverse reactions to be reported once a drug is used by a wider population -- and Viagra registered record sales since it went on the market last month.
"The bottom line is that we are not seeing anything beyond the experience of our clinical trials," Caprino said. "Everything is in line with what we experienced in the clinical trials."
Side-effects include headaches, flushing, nausea and an odd effect on the eyes that renders some men temporarily unable to distinguish between green and blue. |
