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Blindness Cases May Lead to Viagra Label Revision

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The U.S. Food and Drug Administration (FDA) is in talks with Viagra maker Pfizer Inc. about a possible revision to Viagra’s label based on rare cases of blindness that have been reported in connection the drug.

So far, no evidence has proved that these cases were directly caused by Viagra, but the FDA has identified 50 cases of varying degrees of blindess occuring in men with heart disease and/or diabetes.

Blindness Cases May Lead to Viagra Label Revision

“It’s an extraordinarily rare complication – perhaps of the underlying condition that the patient has,” said Deutsche Bank Securities analyst Barbara Ryan. “I don’t personally think it’s that significant.”

The specific blindness condition in question is called non-arteritic anterior ischemic optic neuropathy (NAION), and is the result of eye nerves not receiving blood flow. This can lead to permanent loss of sight. According to Zee News,

Dr. Michael Berelowitz, Pfizer’s vice president for worldwide medical, said in an interview he did not think the FDA would require a ”black box” warning – the strongest for prescription drugs – about the Naion reports.

Pfizer contacted the FDA about the blindness cases in March, after a study in the journal of neuro-ophthalmology reported seven Naion cases in Viagra users, Berelowitz said. The study said the cases occurred within 36 hours after the men took Viagra.

Currently, Viagra’s label warns of a potential increase in sensitivity to light or blurred vision. It also mentions past reports of increased intraocular pressure, retinal vascular disease and other eye problems.

Viagra has also been in the news recently for another reason. Convicted sex offenders have been getting Viagra and other erectiledysfunction drugs from Medicaid. Lawmakers are now in the process of putting an end to this.

Medicaid spends an estimated $38 million a year on these drugs. All but $2 million of this money is on Viagra itself. ”We live in a world of limited resources, and those dollars could be spent more wisely,” said chairman of the Senate Finance Committee, Senator Charles E. Grassley.

New York Governor George Pataki has already cut all public funding for the drugs and has proposed that legislation allow the state to target only the convicted sex offenders. Pfizer shares fell nearly 3% to $28.10 in early trade today.

Chris is a staff writer for WebProNews. Visit WebProNews for the latest ebusiness news.

Blindness Cases May Lead to Viagra Label Revision
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