Yael Waknine
Medscape Medical News 2007. © 2007 Medscape
October 19, 2007 — Sudden loss of hearing has
been reported in patients taking phosphodiesterase 5 (PDE-5)
inhibitors, the US Food and Drug Administration warned healthcare
professionals yesterday.
In some cases, the sudden loss or decrease in hearing was
accompanied by vestibular symptoms such as tinnitus, vertigo, and
dizziness, according to an alert sent from MedWatch, the FDA's
safety information and adverse event reporting program.
The warning was based on 29 postmarketing cases that occurred in
a strong temporal relationship to dosing with sildenafil (Viagra,
Pfizer, Inc), tadalafil (Cialis, Lilly ICOS, LLC), and
vardenafil (Levitra, Bayer Pharmaceuticals Corp), which were
taken for the treatment of erectile dysfunction. Other cases were
also reported during clinical trials.
A few cases have also been reported in patients with pulmonary
arterial hypertension (PAH) taking sildenafil citrate, 20-mg tablets
(Revatio, Pfizer, Inc), to improve their exercise ability.
Hearing loss was temporary in about 33% of patients; for the
remainder, hearing loss was either ongoing at the time of report or
the final outcome not described. In almost all cases, the condition
was one-sided.
Because follow-up information was often limited, it remains
unclear whether these events were caused by medication use,
underlying medical conditions, or a combination of these or other
factors. No information is currently available to determine whether
hearing loss is related to PDE-5 inhibitor dose.
Patients taking sildenafil for PAH who experience sudden changes
in hearing should be advised to immediately contact their healthcare
provider. Those taking PDE-5 inhibitors for the treatment of
erectile dysfunction should immediately discontinue therapy and seek
prompt medical attention.
The safety labeling information for sildenafil 25-, 50-, and
100-mg tablets; tadalafil; and vardenafil has been revised to warn
of this potential risk, and the FDA is currently working with the
manufacturer to revise the labeling for sildenafil 20-mg tablets.
Healthcare professionals are encouraged to report PDE-5
inhibitor-related adverse events to the FDA's MedWatch reporting
program by phone 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.
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