Cases of Blindness in Men on Viagra Reported to FDA
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“A definite causal relationship cannot be established at this time,” said Dr. Howard Pomeranz, a University of Minnesota ophthalmologist who first reported NAION in a Viagra-user in 2000. A total of 14 cases of NAION, each occurring within minutes to hours after Viagra ingestion, was reported by Dr. Pomeranz in the March, 2005 issue of the Journal of Neuro-Opthalmology. All reported cases had atherosclerotic risk factors such as diabetes, hypertension, or hyperlipidemia. These risk factors are also associated with erectile dysfunction, the indication for Viagra; however, the close temporal relationship between onset of blindness and drug ingestion has raised FDA scrutiny. “We are taking this seriously,” said FDA spokesperson Cruzan. NAION is the most common acute optic nerve disease, with thousands of cases reported annually in the U.S. The disorder is associated with swelling of the optic nerve head, possibly as a result of altered blood flow, leading to ischemia. NAION is typically heralded by blurred vision and/or visual field defects, before progressing to complete loss of vision. The Viagra-class of drugs (PDE-5 inhibitors) have long been known to have potential ocular side-effects, which are well-described in the package inserts, but blindness has not been previously reported. A
comparison of Viagra, Levitra and Cialis was the subject of a recent
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