FDA, Pfizer Say There Is No Direct Link Between Viagra, 16 Deaths
June 09, 1998 3:58 PM
WASHINGTON -(Dow Jones)- The Food and Drug
Administration and Pfizer Inc. said Tuesday they
continue to back the impotence drug Viagra, saying the
deaths of 16 men taking the drug haven't been linked to
the blockbuster pill.
FDA spokeswoman Susan Cruzan said the deaths don't
change the agency's opinion about Viagra. "We believe
the drug is still safe and effective for the patient
population it is intended for.
"We cannot identify a direct link betwen Viagra and
these reports of deaths," Cruzan said. "We will continue
to monitor these and other reports for trends that show
any change in the drug safety profile just as we do for
any other drug."
An additional eight people died during the drug's clinical
trials.
Of the 16 postmarketing reports, some contain
incomplete information, and Cruzan said the deaths
could have been the result of an underlying disease.
The 16 deaths are listed on the agency's World Wide
Web site. According to information at the site, most of
the men had suffered from conditions ranging from
diabetes to congestive heart failure to high blood
pressure, among others. Most of the men were in their
60s and 70s, although one man was 48 and another was
80.
In several of the cases, the reports said the men
collapsed during or shortly after sexual activity.
"We also have to put this into perspective with the
number of prescriptions written for Viagra," Cruzan said.
Pfizer spokesman Andy McCormick said 1.7 million
prescriptions have been written since the FDA cleared
the drug March 27. He more than one million men have
used the drug and 80% are over age 50.
"There is guidance to the physicians on the label that
says in this age population a thorough medical evaluation
should be done because sexual intercourse is a form of
physical exertion," McCormick said.
Last week Pfizer sent letters to 600,000 doctors who
may prescribe Viagra explaining that the drug shouldn't
be given to patients taking nitrates. Of the 16 deaths
reported to the FDA, two patients were given
nitroblycerin after experiencing chest pains.
When a patient dies or has a complication while using a
drug, the FDA requires companies to report the case to
the agency within 15 days.
The company is continuing to study Viagra in different
groups of patients, McCormick said.
Since Viagra hit pharmacy shelves in April, sales have
totaled more than $130 million, according to
Scott-Levin, a health-care marketing company.
Dr. Barney Rosen, an analyst who follows the
pharmaceutical industry for Argus Research Corp., said
he doesn't think the reports of deaths will stop men from
asking for Viagra.
"Sex sells," Rosen said. "People will say 'it's not going to
hurt me.'"
Men will discover that Viagra doesn't work for
everyone, he said. The company estimates it works for
about 70% of impotent men.
Other impotence products will eventually benefit from
Viagra's success.
"Viagra is getting people out of the woodwork," Rosen
said. "People who can't use it because they have heart
conditions or people it doesn't work in will turn to the
other products."
-Otesa Middleton; 202-862-6654
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