FDA Orders New Warning Labels on Impotence Drugs
The U.S. Food and Drug Administration today approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss while cautioning that it's impossible to know if the pills are to blame. The move comes as the agency is under increasing pressure to investigate drug side effects more aggressively.
"A small number of men have lost eyesight in one eye some time after taking Viagra, Cialis, or Levitra," the new labels read.
At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called NAION or non-arteritic anterior ischemic optic neuropathy. NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Moreover, risk factors include diabetes and heart disease, two of the leading causes of impotence.
The FDA has 43 reports of NAION among the impotence drug users: 38 for Viagra, four for Cialis and one for Levitra. They include varying degrees of vision loss, including blindness. According to Pfizer, Inc., Viagra has been used by more than 23 million men worldwide since it went on the market seven years ago, and instances of blindness brought on by NAION are extremely rare.
The FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care 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.
The US Food and Drug Administration said however that "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," including high blood pressure or diabetes. Other risk factors include being over age 50, heart disease, high cholesterol and smoking.
[tags]edrugstore, viagra, levitra, cialis, impotence drugs, blindness, FDA[/tags]
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