Articles about Eye Health and Disease from 2005
Reports of Sudden
Vision Loss Added to Labeling for Viagra, Cialis, Levitra
News Release July 8, 2005
The U.S. Food and Drug Administration (FDA) has advised healthcare
professionals via news release of a potential risk of sudden vision
loss that may be attributed to use of phosphodiesterase 5 (PDE-5)
inhibitors.
As of May 18, 2005, the FDA has received a total of 43
post-marketing reports of ischemic optic neuropathy in patients
using:
-
Viagra (sildenafil citrate)
- 38 patients
-
Cialis (tadalafil) -
4 patients
-
Levitra (
vardenafil HCl) - 1 patient
A majority of these
cases (36) appear to be of the non-arteritic anterior ischemic optic
neuropathy (NAION) subtype; in 26 of these, the loss of vision has
been described as continuing or permanent.
According to the news release, sudden vision loss in one eye due to
NAION has been reported in a small number of patients taking the
above listed medications for the treatment of erectile dysfunction
(ED).
Because many of these adverse events were reported in patients with
vascular risk factors for NAION that overlap with those for ED (such
as age older than 50 years, low cup to disc ratio, hypertension,
diabetes, smoking, etc), the causal role of PDE-5 inhibitors remains
unclear.
The FDA notes that the clinical attributes of some of the cases (eg,
a temporal relationship in 19 sildenafil cases, four tadalafil
cases, and one vardenafil case; recurrent ocular symptoms suggestive
of NAION in five sildenafil cases) are a cause for concern.
Patients should be advised to discontinue use of the products and
seek immediate medical attention if they experience a sudden
decrease/loss of vision in one or both eyes. This may be a sign of
NAION, which can result in permanent loss of vision.
Patients also should be advised of risk factors for NAION (such as a
previous episode, age older than 50 years, and a history of heart
disease, diabetes, high blood pressure, high cholesterol, or
smoking) and the potential role of vasodilators such as PDE-5
inhibitors in inciting its occurrence.
Further information concerning use of sildenafil citrate, vardenafil
HCl, and tadalafil may be obtained online at:
Adverse events related to the use of sildenafil citrate, vardenafil
HCl, or tadalafil should be reported to the FDA's MedWatch program
by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane,
Rockville, MD 20852-9787.
Return to the Eye News Index
of Articles Page
What's New at