 FDA Asked To Require Blindness Label
on Viagra - Viagra ®, Cialis ®, Levitra ® Linked to Blindness
Viagra & Erectile
Dysfunction News Alerts, Lawsuits and Lawyer Updates
The U.S. Food and Drug Administration has been asked to add the most
serious of warnings to Viagra’s label because of new reports linking
the medication to vision loss. Some of the more than 23 million men
who have used Viagra have gone blind, and a recent study shows that
Viagra increases blood circulation to the optic nerve, causing a
type of vision loss called NAION, for non-arteritic anterior
ischemic optic. NAION occurs when small arteries surrounding the eye
do not get enough blood, causing a spontaneous stroke in the optic
nerve.
In a petition filed with the FDA, the prominent consumer advocacy
group Public Citizen noted that Viagra accounts for more cases of
NAION than any other drug (19 percent) and more than double the
percentage of the next most often-reported drug. Public Citizen
obtained these results by analyzing data from the FDA’s Adverse
Event Reports database. The group also found that the number of case
reports of NAION per million prescriptions was 18-fold higher for
patients taking Viagra and 25 times higher for Cialis compared to
patients taking Lipitor, another drug used by people with similar
cardiovascular risk factors.
After nearly 50 reports of temporary or permanent blindness stemming
from Viagra use, in July 2005 the FDA updated the labeling for
Viagra and other impotence drugs to reflect the post-marketing
reports of sudden vision loss attributed to NAION. The FDA advised
patients to stop taking the medicines and call a doctor or
healthcare provider right away if they experience sudden or
decreased vision loss in one or both eyes.
Viagra was originally approved by the FDA on March 27th 1998, and
has since been prescribed to as many as 23 million patients
worldwide. The first case of NAION in a Viagra user was reporter in
2000. Critics say Pfizer, the manufacturer of Viagra, did not
properly warn consumers of the potentially dangerous side effects
such as blindness and strokes, and the FDA took no action for five
years, ignoring early warning signs and not taking potentially fatal
side effects seriously.
Other side effects of Viagra and similar erectile dysfunction drugs:
- Stroke
- Complete vision loss
- Temporary, blurred vision
- Dyspepsia
- Palpitations
- Urinary tract infections
- Prolonged erections
Men who are more susceptible to NAION
include those who:
- are over 50 years old
- have heart disease
- have diabetes
- have high blood pressure
- have high cholesterol
- smoke
- have certain eye problems
VIAGRA LAWYERS / ATTORNEYS
If you or a loved one have suffered from the dangerous side
effects of Viagra, you should consider receiving a free legal
evaluation from an experienced injury lawyer. For a free evaluation
of your situation please complete the following form and a Viagra
attorney will contact you promptly -- free of charge.
Viagra Erectile Dysfunction NEWS
& LAWYER UPDATES
Impotence Drugs Under Attack
CBS News - October 2005
... 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. Risk
factors include diabetes and heart disease, which are also two of
the leading causes of impotence. In July, the FDA ordered less
prominent warnings be added to the labels of the three impotence
drugs. The warnings noted that some users have suffered vision loss
but cautioned it was impossible to know if the pills are to blame.
Feds Eye Viagra-Blindness Reports
CBS News - April 2005
... Federal health investigators are looking into
reports that some men who used Viagra may have suffered a new and
very serious side effect -- blindness. Twenty-three million
men worldwide have used Viagra. A very small number of them are
going blind after taking normal doses. And CBS News has learned from
the FDA that it is urgently meeting about it with experts and
Pfizer.
Treatment of Erectile Dysfunction
Cornell University
...
Viagra should not be used by certain patients: patients who are on
any form of nitrate therapy (pill, spray, paste, or patch) as the
combination of the 2 drugs has been shown to lower the blood pressure to a
dangerous level. Men with significant cardiac disease are at higher risk of
problems. These patients include: heart attack within the last 3 months;
poorly controlled high blood pressure; poorly controlled angina (cardiac
chest pain); stroke within the last 3 months; severe congestive heart
failure; and heart valve disease.
FDA Alert
FDA -
July
2005
... Physicians should: advise patients to stop use of all PDE-5
inhibitors and seek medical attention in the event of a sudden loss
of vision in one or both eyes. Such an event may be a sign of non-arteritic
anterior ischemic optic neuropathy (NAION), a cause of decreased
vision, which can result in permanent loss of vision. Discuss
with patients the increased risk of NAION in individuals who have
already experienced NAION in one eye, including whether such
individuals could be adversely affected by use of vasodilators such
as PDE-5 inhibitors.
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