Viagra Label Update Progresses At FDA

    NEW YORK, June 27 /PRNewswire-FirstCall/ -- Pfizer Inc said today that a
review of all post-marketing ocular event reports has concluded that there is
no evidence of increased risk of blindness among patients taking Viagra.
    "There is no evidence that Viagra causes blindness or any other serious
ocular condition," said Dr. Joseph Feczko, Pfizer's chief medical officer.
"Men taking Viagra are at no greater risk for blindness -- including vision
loss from NAION -- than men of similar age and health not taking the
medicine."
    Pfizer said discussions are progressing with the U.S. Food and Drug
Administration to update the Viagra label to reflect rare reports of
non-arteritic anterior ischemic optic neuropathy (NAION) in some men who have
used the medicine.
    While the FDA concluded that no causal relationship between Viagra and
NAION has been established, Pfizer has agreed with the agency to include the
fact of these reports in the Viagra label to help inform physicians and
patients.  It is Pfizer's understanding that the FDA has asked that similar
information be included in the labels of all oral ED medicines.
    NAION, among the most common acute optic nerve diseases in older adults,
shares a number of common risk factors with erectile dysfunction: over 50
years of age, high blood pressure, high cholesterol, and diabetes.
    Since Viagra was introduced in 1998, Pfizer and regulatory authorities
around the world have regularly reviewed all reported adverse events,
including those involving the eye.  No regulatory authority has concluded that
Viagra use is associated with an increased risk for blindness.  Most of the
reported NAION cases occurred in Viagra users with underlying anatomic or
vascular risk factors associated with the development of NAION.
    Pfizer has shared this information with CBS News, which plans to air a
story tonight highlighting reports of blindness with Viagra.  Pfizer said it
is concerned that such news reports unnecessarily alarm patients.
    "After more than 10 years of rigorous clinical study and worldwide safety
monitoring of a medicine used by more than 27 million men, there is no
evidence to suggest a link between Viagra and blindness or other serious
ocular events," Dr. Feczko said. "In addition, several studies specifically
looking into the effect of Viagra in the eye by Pfizer as well as independent
ophthalmologic experts found Viagra to have no serious adverse effects on the
eye."
    As with any medication, patients should consult their physician about use
and follow the product's prescribing information.

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CONTACT:
Daniel Watts of Pfizer, +1-212-733-3835

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