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U.S. OKs new vision warning for Viagra-like drugs

July 8, 2005

WASHINGTON (Reuters) – The U.S. Food and Drug
Administration on Friday approved new labeling to warn men
about possible blindness from Pfizer Inc.’s Viagra and other
drugs for erectile dysfunction.

Cialis, sold by Eli Lily & Co. and Icos Corp., and Levitra,
which is co-promoted by GlaxoSmithKline and Bayer AG, will also
carry new labels.

Pfizer agreed last month to change the popular impotence
drug’s label but said a company review found no evidence of
increased risk of blindness in patients taking the drug.

FDA officials said they did not know if the drugs cause the
blindness.

The new label said such vision loss, known as non-arteritic
anterior ischemic optic neuropathy, “has been reported rarely.”
Thirty-eight cases in Viagra users have been reported to the
FDA as of May 27.

It also tells doctors to discontinue the medication “and
seek medical attention in the event of a sudden loss of vision
in one or both eyes.”

Those most at risk for the vision loss are patients older
than 50 who have diabetes, heart disease, high blood pressure,
and high cholesterol, among other ailments, the label said.

An online version of the label is online at

http://www.fda.gov/cder/foi/label/2005/020895s021lbl.pdf




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