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I associated with vision impairment related to NAION (non-arteritic
anterior ischemic optic neuropathy) in certain patients taking these
drugs in the post-marketing (outside of clinical trials) setting. Most,
but not all, of these patients had underlying anatomic or vascular risk
factors for development of NAION unrelated to PDE5 use, including: low
cup to disc ratio (“crowded disc”), age over 50, diabetes,
hypertension, coronary artery disease, hyperlipidemia and smoking.
Given the small number of NAION events with PDE5 use (less than 1 in 1
million), the large number of users of PDE5 inhibitors (millions) and
the fact that this event occurs in a similar population to those who do
not take these medicines, the FDA concluded that they were not able to
draw a cause and effect relationship, given these patients underlying
vascular risk factors or anatomical defects. However, the label of all
three PDE5 inhibitors was changed to highlight clinicians to a possible
association.
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