Erectile Dysfunction Drugs Linked to Risk for Hearing Loss

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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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