| Andrew 2005-07-09, 5:47 pm |
| http://abcnews.go.com/US/print?id=923095
FDA Orders Warning Label on Viagra
FDA Orders Warnings Labels on 3 Impotence Drugs After Some Users
Developed Form of Blindness
The Associated Press
Jul. 9, 2005 - The government on Friday ordered warnings onto the
labels of Viagra and two other impotence drugs after some users
developed a form of blindness while cautioning that it's impossible to
know if the pills are to blame.
The Food and Drug Administration's move comes as the agency is under
intense pressure to investigate more aggressively and warn the public
about drug side effects.
At issue is sudden vision loss when blood flow to the optic nerve is
blocked, a condition called NAION or non-arteritic anterior ischemic
optic neuropathy.
NAION is considered one of the most common causes of sudden vision
loss in older people, with anywhere from 1,000 to 6,000 cases a year.
Moreover, risk factors include diabetes and heart disease, two of the
leading causes of impotence.
The FDA has 43 reports of NAION among the impotence drug users: 38 for
Viagra, four for Cialis and one for Levitra. They include varying
degrees of vision loss, including blindness.
Those are rare numbers, given that Viagra alone has been used by 23
million men worldwide since its approval in 1998, according to maker
Pfizer Inc.
"It is not possible to determine whether these oral medicines for
erectile dysfunction were the cause," or whether other health
conditions triggered NAION in the men, the FDA said in a statement
Friday.
In addition to heart disease and diabetes, risk factors include being
over age 50, high blood pressure, high cholesterol and smoking.
But FDA advised patients to stop taking the pills and call a doctor if
they experience sudden or decreased vision loss in one or both eyes
and to tell their doctor if they have ever suffered an episode of
sudden vision loss, because such patients are at increased risk of a
second episode.
Cialis is marketed by Eli Lilly & Co. and ICOS Corp. Levitra is sold
by GlaxoSmithKline PLC and Schering-Plough Corp. in the United States,
and by Bayer AG elsewhere.
Shares of Pfizer rose 39 cents, or 1.5 percent, to close at $27.14;
shares of Eli Lilly rose $1.04, or 1.9 percent, to $56.25; shares of
GlaxoSmithKline rose 2 cents to close at $48.24; and shares of
Schering-Plough rose 49 cents, or 2.6 percent, to close at $18.97, all
in Friday trading on the New York Stock Exchange. Shares of ICOS rose
84 cents, or 3.9 percent, to close at $22.15 on the Nasdaq Stock
Exchange.
On the Net:
FDA information on the three drugs:
http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm
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