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WASHINGTON (Reuters) -
U.S. regulators on Thursday added
new warnings about the potential risk of sudden hearing loss to
best-selling impotence drugs Viagra, Cialis, and Levitra, used
by millions of men.

The U.S. Food and Drug said a published
report of a man taking Pfizer Inc&39;s side effect data found 29
cases of sudden hearing loss with a relationship to the three
drugs.

In one third of the cases the hearing loss was temporary,
the agency said, the remaining cases were described as ongoing
at the time of the report or the outcome was not described.

Eli Lilly sells Cialis and GlaxoSmithKline Plc sells
Levitra. Pfizer&39;s safety
data-base are widely viewed as representing only a fraction of
actual problems with drugs and medical devices.

Drugmakers Pfizer and Lilly both said their data did not
show any causal relationship between hearing loss and the
drugs. The FDA said no causal link has been established.

Pfizer vice president for medical affairs, Dr. Ponni
Subbiah, said hearing loss was included in Viagra&39;s Bayer AG sold the drug
originally.

Schering-Plough spokesman Lee Davies said the company would
comply with the FDA's request and said all the hearing loss
cases were temporary.

About 4,000 new cases of sudden hearing loss occur in the
United States annually, according to the National Institute on
Deafness and Other Disorders. It typically occurs
in one ear, and symptoms include ringing in the ear and
dizziness.

The condition resolves itself in some cases, but in 15
percent of cases, it gets worse over time, according to the
institute.

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