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FDA Orders Viagra Blindness Warning Label

Posted by JOE GANDELMAN, Editor-In-Chief in At TMV.
Jul 10th, 2005 | 632 responses

The FDA has ordered the impotence drug Viagra and other erectile dysfunction drugs to carry a stiff warning about blindness:

The Food and Drug Administration approved new labeling Friday to warn men about possible blindness from Pfizer Inc.’s Viagra and other drugs for erectile dysfunction.

Cialis, sold by Eli Lilly & 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 (Research), 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.

The Washington Post adds this:

Yesterday’s announcement followed a number of public disputes about the possible link. The FDA first mentioned it publicly in late May, after news reports of the risk based on a study in an ophthalmology journal…..

While the FDA internally debated a possible label change, Pfizer Inc., which makes Viagra, said last month that it did not believe its drug was causing the sudden blindness.

“There is no evidence that Viagra causes blindness or any other serious ocular condition,” said Joseph Feczko, the company’s chief medical officer. “Men taking Viagra are at no greater risk for blindness — including vision loss from NAION — than men of similar age and health not taking the medicine.”

But the FDA announcement yesterday offered a somewhat different perspective. It said that it was “not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” But because of the possible connection, it said, Viagra, Cialis (made jointly by Eli Lilly & Co. and Icos Corp.) and Levitra (made by Bayer Pharmaceuticals) all should carry information about the risk.

In other words: the FDA doesn’t want to take any chances.

An online version of the label (pdf file) can be found here. But we have some BETTER ideas:

SUGGESTED VIAGRA WARNING LABELS

Warning: Viagra May Make You Blind Just Like The Thing Your Mother Warned You About

Warning: Viagra could impair your vision and after you take it be sure you don’t lie down underneath a low ceiling fan.

Warning: Taking this product has vision risks but it can help you if you’re in a nudist colony and need to carry a bag in each hand and also a bunch of donuts.

Warning: This product may be hazardous to your eyesight but in other ways it’ll straighten you out.

Warning: This product may be impact your vision but if you’re a lawyer you’ll grow taller.

Great cartoon graphic is from Peter Wagner’s website.

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FDA Orders Viagra Blindness Warning Label

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