 |
|
|
 Health & Beauty | July 2005 
Mexico to Require Warning Labels
 Wire services
| | While the stickers will say the drugs can cause blindness, companies say the chances of this are minimal. |
Mexico asked the manufacturers of the impotence drugs Viagra, Cialis and Levitra to include a warning label about a remote risk of blindness on Friday, the same day the Food and Drug Administration ordered warnings included on U.S. labels.
The U.S. FDA statement includes a disclaimer cautioning that it's impossible to know if the pills are to blame for a rare form of blindness.
In a press statement, The Health Secretariat announced that manufacturers of the pills "will be required to include warning labels on the package." Manufacturers said they will have 240 days to implement the measure.
"There have been very rare reports of a connection between the use of these medications and optical neuropathy," the Mexican warning states.
But the warning does note that the side effect optic neuropathy, a nerve disorder occurs only "in a very small number of cases." The agency estimated that only about 38 cases have been detected, among the estimated 30 to 40 million users of the drugs.
"There have been very rare reports of a connection between the use of these medications and optical neuropathy," the warning states.
Mony de Swaan, Pfizer Mexico's regional director of corporate affairs, said his company is proposing that the Mexican warning be altered to specify that the blindness has occurred in only about one in a million users.
At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called non-arteritic anterior ischemic optic neuropathy.
The warning also advises doctors to suspend use of the pills in the case of sudden loss of vision. |
| |
|
Vallarta Weddings
Tell a Friend
Site Map
Print this Page
Email Us