WASHINGTON (Reuters) -
U.S. regulators on Thursday added
new warnings about the potential risk of sudden hearing loss to
2005 daily mar order statistics valium
impotence drugs Viagra, Cialis, and Levitra, used
by millions of men.
The U.S. Food and Drug Administration said a published
report of a man taking Pfizer Inc's Viagra, who suffered from
sudden hearing loss, prompted it to explore a possible
impotence medicine
.
A further review of the FDA's side effect data found 29
cases of sudden hearing loss with a impotence supplements
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 Levitra vardenafil hcl Plc sells
Levitra. Pfizer's Revatio, a version of Viagra used for a lung
condition, will also carry a new warning.
Erectile dysfunction drugs are a huge business, with Pfizer
reporting Viagra sales of $450 million in its most recent
quarter. The drugmakers are all cooperating with the FDA and
defended the safety of their drugs.
The new label warnings follow a 2005 label change noting
cases of sudden vision loss in some patients.
Reports of serious side effects to the FDA'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's adverse
events section of its label upon its 1998 FDA approval. It
occurred in less than 2 percent of patients in clinical trials,
which she said was statistically comparable to those in a
placebo group.
About 30 million men have taken Viagra since its approval
in 1998 as the first cialis levitra review
drug for erectile dysfunction,
according to Pfizer.
Lilly spokeswoman Keri McGrath said a recent Lilly review
found about 1.1 incidents of sudden hearing loss per million
Cialis patients, which she said was lower than the incident
rate in the general population. Nearly 12 million men have been
prescribed the drug, the company said.
Schering-Plough Corp. and GlaxoSmithKline co-market Levitra
in the United States, while Germany'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 Communication 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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