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Senior Citizens & Sex
Risk of Sudden Hearing Loss Gets More Emphasis on
Viagra, Levitra and Cialis Labels
Hypertension drug Revatio to get same warning as
erectile dysfunction drugs
 Oct. 18, 2007 The potential risk of sudden
hearing loss, and a guide for consumers on what to do if they experience
sudden problems with their hearing, will be made more prominent on the
labels for erectile dysfunction (ED) drugs in the class that includes
Cialis, Levitra, and Viagra, according to an announcement today by the
Food and Drug Administration. The FDA points out that hearing loss is a
common ailment for senior citizens, major users of ED drugs, but sudden
hearing loss is uncommon at any age.
Hearing loss is very commonly reported in an aging population,
especially in patients with risk factors for erectile dysfunction,
according to the FDA.
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However, sudden hearing loss is an uncommon event
at any age. It is not known whether age was a factor in the cases of
sudden hearing loss reported in temporal relation to use of the PDE5
inhibitors, the agency said in a Q&A presentation. (Read Q&A below news
story for more information).
The FDA announced it also plans to require the same
changes in labeling for the drug Revatio, also a member of this drug
class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is
used to treat pulmonary arterial hypertension (PAH). PAH is a serious
medical condition in which continuous high blood pressure in arteries of
the lungs weakens the heart muscle and often leads to right heart
failure and death.
The FDA asked manufacturers of these drugs to
revise product labeling after a very small number of patients taking the
PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by
ringing in the ears and dizziness.
Because some level of hearing loss is usually
associated with the aging process, patients on these drugs may not think
to talk to their doctor about it, said Janet Woodcock, M.D., FDAs
deputy commissioner for scientific and medical programs, chief medical
officer, and acting director of its Center for Drug Evaluation and
Research.
Patients taking Cialis, Levitra, or Viagra who
experience sudden hearing loss should immediately stop taking the drug
and seek prompt medical attention.
Those using Revatio should continue taking their
medication but should contact their health care provider for further
evaluation. Because Revatio is used to treat a potentially
life-threatening condition, the FDA does not recommend patients abruptly
stop taking this medication but should consult their physician if they
experience sudden problems with their hearing.
A case report in the April 2007 issue of the
Journal of Laryngology & Otology involving sudden hearing loss in a man
taking Viagra prompted the FDA to search the FDAs Adverse Events
Reporting System for instances of hearing loss and PDE5 inhibitors.
The FDA found a total of 29 postmarketing reports
of sudden hearing loss, both with and without accompanying ringing in
the ears, vertigo, or dizziness. In most of the cases, the hearing loss
involved one ear.
The hearing loss was either a partial or complete
loss of usual hearing. In approximately one third of cases, the event
was temporary. In the remainder, the hearing loss was ongoing at the
time of the report or the final outcome was not described.
Although no causal relationship has been
demonstrated, the strong relationship between the use of these drugs and
sudden hearing loss in these cases warrants revisions to the product
labeling for this drug class.
Product Web sites, marketing and educational
materials, and advertisements for PDE5 inhibitors will reflect the
revised product labeling. The label revisions can be viewed at:
www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.
Questions and Answers about
Viagra, Levitra, Cialis, and Revatio:
Possible Sudden Hearing Loss
1. What is FDA announcing today?
FDA has approved labeling changes for the phosphodiesterase Type 5
(PDE5) inhibitor class of erectile dysfunction (ED) drugs, Cialis,
Levitra, and Viagra. In addition, FDA plans to revise the labeling for
the pulmonary arterial hypertension (PAH) drug Revatio. This change is
being implemented to display more prominently the potential risk of
sudden hearing loss. FDA plans to issue a Healthcare Professional Sheet
that will provide additional information about this potential risk.
2. Why is FDA making this announcement?
The FDA is making this announcement as part of its ongoing commitment to
inform consumers of emerging health issues with marketed drugs. The
Agency believes that by making this announcement it will better inform
consumers taking these drugs of this possible risk and guide them on
what to do if they experience sudden problems with their hearing.
3. What prompted FDA to request these labeling
changes?
A case report in the published literature of sudden hearing loss in a
male patient taking Viagra prompted FDA to search the Adverse Event
Reporting System (AERS) for postmarketing reports of hearing impairment
for all PDE5 inhibitors. FDA found a total of 29 reports of sudden
hearing loss, both with and without accompanying vestibular symptoms
(tinnitus, vertigo or dizziness), in strong temporal relationship to
dosing with Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenadil).
Hearing loss was also reported in a few patients in clinical trials of
these drugs. There have also been cases of hearing loss reported in
patients using Revatio (sildenafil) for the treatment of pulmonary
arterial hypertension (PAH). Though no causal relationship has been
demonstrated, FDA believed that the strong temporal relationship between
the use of PDE5 inhibitors and sudden hearing loss in these cases
warranted revisions to the product labeling for the drug class.
4. Who is more likely to be at-risk for this
possible side effect?
The available information is not sufficient to determine if any type of
patient is more likely to be at-risk for this possible side effect.
5. Is age a factor in being predisposed to
hearing loss or to sudden hearing loss?
Hearing loss is very commonly reported in an aging population,
especially in patients with risk factors for erectile dysfunction.
However, sudden hearing loss is an uncommon event at any age. It is not
known whether age was a factor in the cases of sudden hearing loss
reported in temporal relation to use of the PDE5 inhibitors.
6. Is this side effect permanent or temporary?
In approximately one third of the cases, the event was temporary. In
the remainder, the hearing loss was ongoing at the time of the report or
the final outcome was not described. In almost all cases, the hearing
loss was one-sided.
7. What are the warning signs?
There were no predictable warning signs for sudden hearing loss in the
reported cases.
8. What should I do if I experience sudden
hearing loss?
Patients taking Revatio for the treatment of pulmonary arterial
hypertension who experience sudden changes in their hearing should
promptly contact their health care provider for further evaluation.
However, patients taking Cialis, Levitra or Viagra for the treatment of
ED who experience sudden hearing loss should immediately stop taking the
drug and also seek prompt medical attention.
9. Are there other hearing-related side effects
that I need to be on the look out for?
In some cases, sudden hearing loss was accompanied by ringing in the
ears and dizziness.
10. What dosage level puts me at greatest risk
for this possible side effect?
The available information is not sufficient to determine if any dosage
level puts a patient at greater risk for this possible side effect.
11. Is there an alternative drug for my erectile
dysfunction that doesn't have this possible side effect?
The possible side effect of sudden hearing loss has been reported for
all of the PDE5 inhibitors. You should discuss other treatment options
for ED with your healthcare provider.
12. Is it safe to take these drugs without
putting myself at risk for this possible serious side effect?
PDE5 inhibitors are safe and effective for the treatment of ED when
taken according to the labeling. However, all drugs carry risks and you
should discuss any concerns you have regarding taking these products
with your healthcare provider
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