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Pfizer says no blindness risk from Viagra

June 27, 2005

NEW YORK (Reuters) – Pfizer Inc. on Monday said a
review of its popular impotence treatment Viagra turned up no
evidence of increased risk of blindness among patients taking
the erectile dysfunction drug.

Nevertheless, Pfizer said it is in talks with U.S.
regulators about revising the Viagra label to reflect rare
reports of a serious ocular condition known as non-arteritic
anterior ischemic optic neuropathy (NAION) in some men who have
used the medicine.

Pfizer said it believes the U.S. Food and Drug
Administration has asked that similar information be included
in the labels of all oral erectile dysfunction (ED) medicines.

In the lucrative ED market, Viagra competes with Cialis,
sold by Eli Lily & Co. and Icos Corp. , and
Levitra, which is co-promoted by GlaxoSmithKline and
Bayer AG .

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, the world’s
largest drugmaker said.

“There is no evidence that Viagra causes blindness or any
other serious ocular condition,” Joseph Feczko, Pfizer’s chief
medical officer, said in a statement.

“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,” Feczko added.




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