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Pfizer and FDA Discuss Possible Changes To Viagra Label

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Pfizer Inc., the maker of Viagra is participating in discussions with the U.S. Food and Drug Administration (FDA) concerning a possible revision of the drug’s label.

There have been reports of blindness in connection with Viagra, though the FDA hasn’t found any evidence yet that the drug is the cause. The FDA has however identified 50 cases of varying degrees of blindess occuring in men with heart disease and/or diabetes.

Pfizer and FDA Discuss Possible Changes To Viagra Label

“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 blindness condition in question is known as non-arteritic anterior ischemic optic neuropathy or NAION. NAION is the result of the eye nerves not receiving blood flow, which potentially causes permanent loss of vision. As MarketWatch explains,

Viagra, approved by the FDA in 1998, works by helping to regulate blood flow. The drug’s label already warns of certain cardiac risks and vision problems, such as blurred vision and sensitivity to light.

Rumors that Viagra could cause blindness in some users have circulated for months. In late March, a group of ophthalmologists at the University of Minnesota Medical School published a review of 14 such cases in the March edition of the Journal of Neuro-ophthalmology.

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 trading today.

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

Pfizer and FDA Discuss Possible Changes To Viagra Label
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