Bloomberg - Pfizer's Viagra Not Direct Cause in Deaths, FDA Says (Update6)
Bloomberg News
June 9, 1998, 2:07 p.m. PT
Pfizer's Viagra Not Direct Cause in Deaths, FDA Says (Update6)
(Closes shares, changes wording in first and last
paragraphs.)
Washington, June 9 (Bloomberg) -- Pfizer Inc.'s impotence
drug Viagra hasn't been found to be the direct cause of death in
any of the 16 reports involving users of the drug who died, the
Food and Drug Administration said, sending shares soaring.
Most of the men in the reports were between the ages of 60
and 80, and had a history of cardiovascular problem, according to
reports listed by the FDA in an update on its monitoring of the
Pfizer drug.
''They're not related directly to use of the drug,'' said
Susan Cruzan, a spokeswoman for the FDA. ''They do not change the
FDA's perspective on the use or safety of the drug.''
Pfizer shares rose 4 to close at 112 7/16 today, following
news of the reports. More than 6.4 million shares changed hands,
making Pfizer one of the 15 most actively traded stocks in the
U.S. The rally boosted Pfizer shares above where they were
trading three weeks ago, before the first reports of deaths among
the drug's users sent shares plunging.
The FDA will continue to monitor and investigate all new
reports as they are submitted, as it does with all drugs and
medical products it approves, Cruzan said. If some direct link
between the drug and these deaths or future deaths emerges, the
FDA will take action, she said.
Medical experts said they were not surprised by the number
of deaths. Many of the medical conditions related to impotence --
such as diabetes, high blood pressure and smoking -- also put a
patient at a higher risk for heart attacks and other problems,
whether patients are taking Viagra or not, said Ira Sharlip, a
practicing urologist in San Francisco, California.
''It doesn't seem to me to be out of line for the number of
deaths for that group, whether they are taking Viagra or not,''
Sharlip said.
Warnings on Label
The label for the impotence pill already warns against
mixing Viagra with a common class of heart drugs known as
nitrates. At least three of the deaths in the reports involved
men who were treated with nitroglycerin, a nitrate drug, after
they took Viagra and experienced heart problems.
Viagra is also among the some 25 drugs known to have
potentially dangerous reactions when taken with the heart drug
Posicor, made by Roche Holding AG, which withdrew it from the
market yesterday.
The drug labeling also warns doctors to assess how able
their patients may be to undertake the stress of sexual activity.
About 1.7 million prescriptions for the drug have been
filled, said Andrew McCormick, a spokesman for Pfizer.
The reports so far do not indicate any new side effects of the
drug, he said.
''Everything has been in line with the clinical
experience,'' McCormick said.
In one case report, a 74-year-old man taking four drugs to
treat his high blood pressure, diabetes and cancer died the
morning after taking Viagra. In another case, a 73-year-old man
died during sexual activity after taking a second dose of the
drug. The man had a history of high blood pressure, the report
said.
Worth the Risk?
Patients who are elderly or who have heart problems are at
greater risk when they engage in the physical activity required
by sex. Still, the risks are not alarming, said Sharlip, who also
sits on the American Urological Association's impotence guideline
committee.
''Even though there is an increase in the risk, the risk is
still very small,'' he said. ''I think it makes sense to tell
people that and to then let them make the choice as to whether
having sex is worth that risk.''
In the more than 400 patients he has treated with Viagra,
Sharlip has yet to find a patient who was deterred by the risk of
having sex, he said.
Still the record-breaking popularity of the drug has played
some role in the number of incidents because it is likely many
men are taking the drug who for a number of reasons should not be
because of poor health or conflicting medications, Lisi said.
''These are small numbers in contrast to the amount of
patients using the drug,'' said Steve Lisi, an analyst with Mehta
Partners. Still, ''we're probably going to continue to see this
as people use this drug like aspirin,'' he said.
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 initial reports were filed for one
63 year-old man who died after taking Viagra. That death is only
counted once among the 16 now listed by the FDA, though.
The FDA sorts the reports to eliminate duplicates and is now
posting them on a page on its home page to make the numbers
publicly available, Cruzan said.
The FDA has held its position since the earliest death
reports, saying that any relationship between the deaths and the
drug is unproven, she said.
--Kristin Reed in Washington (202) 624-1858 with reporting by |
