Pfizer's Viagra Used by 69 Who Died; FDA Says Drug Still Safe
Bloomberg News
August 24, 1998, 6:11 p.m. ET
Pfizer's Viagra Used by 69 Who Died; FDA Says Drug Still Safe
Washington, Aug. 24 (Bloomberg) -- Pfizer Inc.'s blockbuster
impotence drug Viagra was taken by 69 patients in the U.S. who
later died, the U.S. Food and Drug Administration said, adding
its opinion of the drug's safety hasn't changed.
In an update posted on its web site, the FDA said between
March and July it received reports of 123 patients who died after
receiving a prescription for Viagra. However, in 42 of those
cases, either the information couldn't be confirmed, because it
came from a rumor or other unverifiable source, or the agency
couldn't be sure the patients actually took Viagra, the FDA said.
Another 12 reports involved patients outside the U.S.
''This posting does not suggest a change in FDA's
perspective concerning the safety of Viagra,'' the agency said on
the web site. ''The intent is simply to provide easier access for
those who have requested this information.''
Officials at the FDA had no further comment. Officials at
New York-based Pfizer couldn't be reached. In the past, the FDA
has said it hasn't found Viagra to be the direct cause of
previously reported death and both the agency and the company
have repeatedly said the drug is safe when used properly.
The latest safety update comes after Public Citizen, a
Washington-based consumer watchdog group, last week petitioned
the FDA to convene an expert advisory panel to review the drug.
Unlike most other new therapies, Viagra didn't pass through an
FDA panel before approval.
Public Citizen said the dangers of the drug aren't fully
understood. Both the FDA and Pfizer said the drug is safe. Viagra
has seen unprecedented demand and garnered sales of more than
$400 million in its first three months on the market.
Shares of New York-based Pfizer fell 11/16 to 105 3/8
earlier. The company has recently faced several lawsuits from men
who claimed they suffered heart attacks after taking the drug,
The 69 deaths include 39 reported July 21, the last time the
FDA issued an official update.
Of the 69 U.S. patients who died after taking Viagra, two
had strokes, 46 suffered some kind of heart problem and 21 died
from unknown or unconfirmed causes, the FDA said.
While the Viagra label doesn't contain a specific warning
for heart patients, it does advise doctors that sexual activity
carries risks, and ''physicians may wish to consider the
cardiovascular status of their patients before prescribing the
drug.''
At least 66 of the patients who died were men, the agency
said. The average age of the patients in 55 reports which
included that information was 64, the FDA said. The ages of
patients who died ranged from 29 to 87, the agency said.
At least 12 of the patients took Viagra along with a heart
medication that the company and the FDA have warned can have a
dangerous interaction with Viagra, the agency said. Most of the
69 patients were also found to have at least one risk factor for
heart disease, the FDA 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 adverse events and will
continue to evaluate the need for further regulatory action,''
the agency said.
--Kristin Jensen in the Washington newsroom (202) 624-1843 with
quote.bloomberg.com |
