–October 20, 2005
Public Citizen consumer group petitioned the U.S. FDA saying the federal agency should immediately require a black box warning for doctors and patients about potential risks of vision loss among patients taking erectile dysfunction drugs.
Including popular drugs Viagra, Cialis and Levitra, the consumer group said the drugs are linked to possible irreversible vision loss called ischemic optic neuropathy (ION). Viagra has accounted for the most cases of ION than any other drug. In fact, Viagra users have reported more than double the percentage of ION incidence over other drugs, with 19 percent of reported cases, according to Public Citizen’s analysis of FDA data.
Based on data from the FDA’s Adverse Event Reports database, the advocacy group found that the number of case reports of ION per million prescriptions was 18-fold higher for patients taking Viagra and 25 times higher for Cialis compared to patients taking Lipitor, a drug also used by people with similar cardiovascular risk factors. Current labeling for the erectile drugs, despite reports of vision loss occurring in close association with the drugs’ use, states that, “It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors.”
In addition to reports of 50 cases of ION, the FDA has received 60 other cases of related conditions, including blindness, blindness unilateral visual field defect, scotoma and optic nerve infarction. Public Citizen responded to the reports of vision loss among Viagra users especially by petitioning the FDA to include the most serious FDA issued drug warning – a black box warning.
The petition also calls on the agency to establish a registry of patients who take the drugs and develop vision loss and to require the drug companies to send “Dear Doctor” letters to all U.S. physicians about signs and symptoms of vision loss associated with the drugs. Public Citizen director Dr. Sidney Wolfe said it is the agency’s job to immediately alert consumers about drug risks and that it “has once again failed in this responsibility.”
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