| Monday, May 30, 2005 |
| FDA PROBES BLINDNESS UB IMPOTENCE DRUG USERS |
43 Cases sudden vision loss prompt talks with drug firms -
WASHINGTON - Federal health officials are probing reports of blindness among dozens of men who used Viagra and other impotence drugs -- but at the same time cautioning that the vision loss can be linked to the same illness that leads to impotence.
The Food and Drug Administration disclosed Friday that it was talking with the makers of Vigra, Cialis and Levitra about what the labels of the drugs should say about the rare cases of varying degress of vision loss, including blindness. The maker of Cialis already has voluntarily added a one line mention to its label.
At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called non-arteric anterior ischemic optic neuropathy.
'We take this seriously'
The FDA has 43 reports of the condition among the impotence drug users; 38 for Viagra, four for Cialis, and one for Levitra, spokewoman Susan Cruzan said.
Vuagra has been used by 23 million men worldwide since its approval in 1998, maker Pfizer Inc. said.
Non-arteritic anterior ischemic optic neuropathy is considered one fo the most common cause of sudden vision loss in older Americans, and estimates suggest 1,000 to 6,000 cases occur a year. Risk factors include diabetes and heart disease, two of the leading causes of impotence.
Still, "we take this seriously," Cruzan said.
The questions come at a time when federal regulators and the drug industry are facing criticism about what they do to ensure the safety of drugs on the market. Pressure on the FDA to investigate reports of side effects has increased since Merck & Co., yanked its pain reliever Vioxx from the market last year because of potentially deadly heart trouble.
Big money is at stake. Pfizer Inc. said in its most recent quarterly filing with the Securities and Exchange Commission that Viagra sales rose 5 percent -- to $438 million -- in the first quarter of the year, Pfizer shares decline Friday on the New York Stock Excahnge after news of the blindness cases.
In January, all of the sexual performance drug are slated to be part of the basic package of medicines Medicare will cover for senior citizens and disabled people who sign up for a new lolunatry prescription plans.
(Associated Press/ by: Lauran Neergaard) |
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Name: infraternam meam
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About Me: I am now at the prime of my life
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