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Erectile Dysfunction Drugs Linked to
Risk for Hearing Loss
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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