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Erectile Dysfunction Drugs & Risk for Blindness
 
 
  "Impotence drugs need stronger warning - US group"
 
2005-10-20
 
By Susan Heavey
 
WASHINGTON (Reuters) - Drugs to treat erectile dysfunction need stronger warnings on their packaging about the risk of blindness, U.S. consumer group Public Citizen said on Thursday in a petition filed with health regulators.
 
The U.S. Food and Drug Administration should "immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 (PDE5) inhibitors that are prescribed for the treatment of erectile dysfunction," Public Citizen's Health Research Group wrote.
 
Pfizer Inc.'s pulmonary hypertension drug Revatio, which has the same active ingredient as its impotence drug Viagra, should also carry a similar black box warning -- the strongest warning the agency can require, the advocacy group said.
 
Earlier this year drugmakers agreed to put information on their impotence drug labels about the possible vision loss, called non-arteritic anterior ischemic optic neuropathy.
 
Viagra, Cialis, sold by Eli Lily & Co. and Icos Corp., and Levitra, sold by GlaxoSmithKline , Bayer AG and Schering-Plough Corp., now carry the new labels, which say the condition "has been reported rarely."
 
Both the companies and the FDA have said the cause of the blindness is not known.
 
But Public Citizen said 19% of all cases of the vision disorder reported to the FDA since 1998 were among users of Viagra.
 
"The fact that Viagra's large numbers of adverse reaction reports occurred without any warnings to the medical profession strongly suggests that Viagra is an important factor in causing (ischemic optic neuropathy)," the petition said.
 
The current label warnings are inadequate, the group said. "The wording is ambiguous and the location of this information is buried," the petition said.
 
Public Citizen also called on the FDA to start a registry of all patients who are diagnosed with the vision disorder. The agency should also require manufacturers to send all U.S. physicians a letter about the risk and call for pharmacists to give FDA-approved leaflets with prescriptions.
 
FDA's handling of the blindness reports has been questioned. In June, Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, requested internal FDA documents and other information about why it took "so long" for the agency to call for the label changes and notify the public.
 
Men most at risk for the vision loss are those older than 50 who have diabetes, heart disease, high blood pressure and high cholesterol, among other ailments.
 
 
 
 
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