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Archive for August, 2007

Lilly’s Response

Cialis is marketed by Lilly ICOS. Levitra is co-marketed by GlaxoSmithKline and Schering-Plough. Those companies — and Pfizer — are WebMD sponsors.

Lilly spokeswoman Kindra Strupp tells WebMD that on May 20 “there was a change to the postmarketing adverse events section … that comes toward the end of the [Cialis] label.

“There were a couple of items that were included under the ophthalmologic events section, which included NAION,” Strupp continues.

“The FDA came back and for all the sponsors there would be precautionary language around NAION,” says Strupp.

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FDA’s Statement

The FDA’s alert reads:

“A small number of men have lost eyesight in one eye some time after taking Viagra, Cialis, or Levitra. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.

“We do not know at this time if Viagra, Cialis, or Levitra causes NAION. NAION also happens in men who do not take these medicines. People who have a higher chance for NAION include those who:

* have heart disease
* are over 50 years old
* have diabetes
* have high blood pressure
* have high cholesterol
* smoke
* have certain eye problems

FDA’s Advice for Patients - Cialis, Viagra, Levitra

The FDA advises patients to stop taking Cialis, Viagra and Levitra and call a doctor or health care provider right away if they experience sudden or decreased vision loss in one or both eyes.

“Further, patients taking or considering taking Cialis, Viagra and Levitra should inform their healthcare professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again,” says the FDA.

“At this time, it is 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,” says the FDA.

Label Change for Viagra, Cialis, Levitra

The FDA has approved updated labeling for the erectile dysfunction drugs Cialis, Viagra, and Levitra. The change reflects a small number of postmarketing reports of sudden vision loss attributed to NAION (nonarteritic ischemic optic neuropathy) , a condition in which blood flow is blocked to the optic nerve, states an FDA news release.

Tens of millions of men worldwide have used the drugs. The reported vision problems have been extremely rare.