OOpsie
06-04-2005, 08:08 AM
WASHINGTON May 27, 2005 — Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and Cialis, a disclosure that comes at a time when the drug industry can ill afford negative publicity about another class of blockbuster medicines.
The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.
This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.
The FDA has 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third impotence drug.
"We take this seriously," said FDA's Cruzan.
The FDA is in discussions about the reported cases with the manufacturers of the three drugs in case there is a problem with the class of medication and to see if changes need to be made to their labels.
Eli Lilly & Co., which manufactures Cialis, refers to vision problems as an uncommon side effect, including seeing a blue tinge or having difficulty telling the difference between blue and green. "These are not all the side effects of Cialis," it says on its Web site.
Viagra manufacturer Pfizer Inc. also refers on its Web site to some vision issues: "Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time." That language had been available before the current inquiry.
Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.
The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.
This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.
The FDA has 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third impotence drug.
"We take this seriously," said FDA's Cruzan.
The FDA is in discussions about the reported cases with the manufacturers of the three drugs in case there is a problem with the class of medication and to see if changes need to be made to their labels.
Eli Lilly & Co., which manufactures Cialis, refers to vision problems as an uncommon side effect, including seeing a blue tinge or having difficulty telling the difference between blue and green. "These are not all the side effects of Cialis," it says on its Web site.
Viagra manufacturer Pfizer Inc. also refers on its Web site to some vision issues: "Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time." That language had been available before the current inquiry.
Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.