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US 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,
co-promoted by GlaxoSmithKline and Bayer AG, will also carry
new labels, the FDA said.

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.
Company officials could not be reached for comment.

Eli Lilly spokeswoman Kindra Strupp said the company had
already voluntarily changed Cialis’ label to include the eye
problems in May. She added the FDA’s announcement would “help
health care practitioners make informed prescribing decisions.”

Nancy Leone, spokeswoman for GlaxoSmithKline, said while
the cause of the blindness was not known the firm agreed with
the FDA’s decision and would continue to monitor for similar
incidents with Levitra.

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. Four cases involving Cialis and one involving Levitra
have also been reported, the FDA has said.

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 posted on the FDA’s Web
site at www.fda.gov/cder/foi/label/2005/020895s021lbl.pdf




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