FDA's class labeling for oral erectile dysfunction drugs on the incidence of non-arteritic anterior ischemic optic neuropathy notes that it is unknown whether the drugs are connected to the adverse events.

"At the time, it is not possible to determine whether these oral medications for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems," FDA's safety alert states.

The class labeling, approved July 8, adds language about the vision loss disorder to the post-marketing experience section of labels for Pfizer's Viagra , GlaxoSmithKline/Schering-Plough's Levitra and Lilly/Icos' Cialis .

"Non-arteritic anterior ischemic optic neuropathy…has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 inhibitors," labeling states.

"Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION."

Labeling also states that it is not possible to determine if the NAION reports were linked to the drugs or to underlying medical conditions.

Pfizer had argued that there was no difference in the incidence of NAION in Viagra patients and patients of similar age and health when it announced it was negotiating label changes in May (¹ Also see "Pfizer In Talks With FDA Over Viagra Label Update To Reflect Vision Loss" - Pink Sheet, 27 May, 2005.).

Cialis labeling also includes post-marketing reports of visual field defect and retinal vein occlusion (² Also see "Viagra Vision Loss Concern Will Prompt Erectile Dysfunction Class Labeling, Pfizer Says" - Pink Sheet, 28 June, 2005.).

Information about NAION was also inserted into the patient information portion of the precautions section of the labels.

The NAION adverse events, which received extensive media attention, will likely be added to direct-to-consumer ads for the ED drugs. GSK said it will include the information in any ad or promotion as per FDA guidance.

The addition of the NAION information in the adverse events section, as opposed to the warnings and precautions sections, appears to go against initial recommendations from an Office of Drug Safety evaluation in 2004.

Sen. Charles Grassley (R-Iowa) cited the ODS recommendation in a June 24 ^FDL-1 letter to Acting Commissioner Lester Crawford questioning the delay in the label changes.

- Brian Marson

Erectile Dysfunction Class Labeling Does Not Assert Causal Link To Vision Loss

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