Pfizer denies Viagra blindness risk

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Pfizer said yesterday that an FDA review concluded there is no evidence of an increased risk of blindness among patients taking the ED drug Viagra.
Nevertheless, the company said it was in discussions with the FDA to revise the label to reflect reports of the ocular condition nonarteritic anterior ischemic optic neuropathy (NAION) in some men that have used the medicine.
"While the FDA concluded that no casual relationship between Viagra and NAION has been established," the company said in a statement, "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."
Pfizer said it has shared this information concerning the review with CBS News which aired a story last night highlighting reports of blindness with Viagra. The company said it is concerned that such news reports unnecessarily alarm patients.
In May, the FDA said it had received a total of 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third approved impotence drug. The agency said at the time that it was still investigating the reports and had no evidence that the drugs are to blame.
Viagra is the dominant drug in the erectile dysfunction category with a 68 percent worldwide market share. Sales of Viagra rose 5 percent to $438 million in the first quarter of 2005.

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