Pfizer's Viagra Now Associated With Four Deaths, Not Six
Bloomberg News
June 1, 1998, 12:32 p.m. PT
Pfizer's Viagra Now Associated With Four Deaths, Not Six
Washington, June 1 (Bloomberg) -- A review of medical
records shows only four of the six men who reportedly died after
using Pfizer Inc.'s Viagra impotence treatment had definitely
taken the drug, the U.S. Food and Drug Administration said.
Last week, New York-based Pfizer said there were six
reported deaths due to either improper mixing of the drug with
other heart medications or the combination of cardiovascular
weakness and sexual exertion.
Of those six reports however, only four involved men who
were confirmed to have taken the drug, agency officials said. Two
other reports have proven to be unreliable or circumstantial, the
FDA determined.
''That's why we review these things,'' said FDA spokeswoman
Susan Cruzan. ''We do encourage people to report to the agency. .
. however we do have to review the reports'' to assess their
credibility, she said. So far, the agency still believes the drug
is safe for its use, Cruzan said.
The results of the FDA investigation were first reported by
the Washington Post.
The MedWatch System
Reports of adverse or even fatal events linked to a drug are
collected through the FDA's MedWatch system, designed to ensure
all reports of problems will be seriously addressed. MedWatch
allows doctors, companies, consumers or pharmacists to file
information on possible side effects found with a drug. However,
these reports may be second- or even third-hand and are not
considered confirmed until they have been evaluated by the
agency.
In addition, more than one report may be filed for a
patient, which may make it appear more people died than was the
case. At least four different reports were filed for one 63 year-
old man who died after taking Viagra.
''It takes quite some time to gather the information to
determine the full circumstances surrounding the events,'' said
Mariann Caprino, a spokeswoman for Pfizer. Caprino said the
company was still confirming the reports.
''There is a lot of misinformation and duplication'' and the
actual number of patients ''can appear at times to be a moving
target,'' Caprino said. ''We don't want to make any kinds of
sweeping statements about these numbers.''
MedWatch records obtained by Bloomberg News through the
government's Freedom of Information Act show that in one of the
two cases that can't be verified, the initial report came from a
pharmacist passing on the comments of a customer who heard of a
Viagra-related fatality on the popular Tonight Show with comedian
Jay Leno.
In the second case, involving a 60 year-old man, there is
evidence that he had been given a prescription for the impotence
treatment, but no evidence that he had actually taken it.
No Change in Label
The label for the impotence pill already warns against
mixing Viagra with drugs in a class known as nitrates, Pfizer
said last week. Neither the drugmaker nor the FDA plan to
change the label for Viagra.
''As you get a better data base, you're better able to put
(reports) into context,'' Cruzan said. ''We continue to believe
that the drug is safe for its labeled indication and intended
patient population.''
Viagra became one of the best-selling drugs within weeks of
its April introduction, and more than 1 million prescriptions for
it have been filled. The deaths took place in men who were
between the ages of 60 and 73, according to the MedWatch reports.
--Kristin Reed in Washington (202) 624- 1858/mmw |
