A: As of May 18, 2005, a total
of 43 cases of vision
loss(ischemic optic neuropathy
(ION)) among patients using
the marketed PDE-5 inhibitors-
sildenafil (viagra), tadalafil
(cialis) and vardenafil(levitra)
have been reported to the FDA.
http://www.fda.gov/cder/drug/InfoSheets/HCP/t
adalafilHCP.htm
of 43 cases of vision
loss(ischemic optic neuropathy
(ION)) among patients using
the marketed PDE-5 inhibitors-
sildenafil (viagra), tadalafil
(cialis) and vardenafil(levitra)
have been reported to the FDA.
http://www.fda.gov/cder/drug/InfoSheets/HCP/t
adalafilHCP.htm
Since approval, 38 cases have been identified in association with sildenafil, 4 cases have
been identified in association with tadalafil and one case has been identified in
association with vardenafil.
Most of these cases (25/43) appear to be the non-arteritic anterior ischemic optic
neuropathy (NAION) subtype.
Thirty-six of the 43 cases reported accompanying visual loss, and 26 of these 36 cases
reported the visual loss as continuing or permanent.
Most of the patients in these cases reported vascular risk factors for NAION that overlap
with vascular risk factors for erectile dysfunction (such as age over 50, low cup to disc
ratio, hypertension, diabetes, smoking, etc), making direct attribution to PDE-5 inhibitors
not possible.
However, the clinical attributes of some of the cases (e.g., a temporal relationship in 19
sildenafil cases, 4 tadalafil cases, and the one vardenafil case, and the report of
recurrent ocular symptoms that might reflect NAION in five sildenafil cases and one
tadalafil case), raise concern in regard to the role of PDE-5 inhibitors.
All cases reported vision loss that was continual or permanent.
Some case were reported from within 2 hrs to 7 days from tadalafil administration.
Some cases reported one or more of the following risk factors for developing ION:
- a low cup to disk ratio or “crowded disc”,
- recent post-operative hypotension, and
- history of hyperlipidemia.
Physicians should:
- advise patients to stop use of all PDE-5 inhibitors and seek medical attention in the
event of a sudden loss of vision in one or both eyes. Such an event may be a sign
of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased
vision, which can result in permanent loss of vision. - discuss with patients the increased risk of NAION in individuals who have already
experienced NAION in one eye, including whether such individuals could be
adversely affected by use of vasodilators such as PDE-5 inhibitors.
FDA has approved new labeling for Cialis, Viagra, and Levitra regarding postmarketing
reports of vision loss related to NAION (non-arteritic anterior ischemic optic neuropathy).
Most, but not all, of these patients had underlying anatomic or vascular risk factors for
development of NAION, including:
- low cup to disc ratio (“crowded disc”),
- age over 50,
- diabetes,
- hypertension,
- coronary artery disease,
- hyperlipidemia and
- smoking.
Given the small number of events, the large number of users of PDE-5 inhibitors and the
fact that this event occurs in a similar population to those who do not take these
medicines, it is not possible to determine whether these events are related directly to the
use of PDE-5 inhibitors, to the patient’s underlying vascular risk factors or anatomical
defects, to a combination of these factors, or other factors.
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informative material on the subjects addressed. It is
written with the understanding that the author(s) is
(are) not engaged in rendering medical, health, or
any other kind of professional service(s). The
reader should consult his or her medical, health or
other competent professional before adopting any
of the suggestions. The author(s) specifically
disclaim all responsibility for any liability, loss, or
risk, personal or otherwise, which is incurred as a
consequence, directly or indirectly, of the use and
application of any of the contents of this site.
of its author(s). It is intended to provide helpful and
informative material on the subjects addressed. It is
written with the understanding that the author(s) is
(are) not engaged in rendering medical, health, or
any other kind of professional service(s). The
reader should consult his or her medical, health or
other competent professional before adopting any
of the suggestions. The author(s) specifically
disclaim all responsibility for any liability, loss, or
risk, personal or otherwise, which is incurred as a
consequence, directly or indirectly, of the use and
application of any of the contents of this site.
