Potential risk of sudden hearing loss with impotence drugs to be displayed more prominently.
Men taking the impotence drugs Viagra, Levitra or Cialis may be at increased risk for sudden hearing loss. Men taking any of these drugs and experiencing hearing loss should immediately stop taking the drug and see their physician, The U.S. Food and Drug Administration (FDA) said.
The FDA has approved labeling changes for impotence drugs to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. The FDA said all manufacturers have agreed to change their labels.
Labeling must also be changed for the blood pressure medication Revatio, which has the same active ingredient as the other drugs. Patients taking Revatio and experiencing hearing loss should not discontinue taking the drug. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend that patients abruptly stop taking this medication. Instead they should consult their physician if they experience sudden problems with their hearing.
The FDA began investigating the possible link between hearing loss and impotence drugs after the publication of an article for ear, nose and throat specialists in last April's Journal of Laryntology and Otology. The study reported on a man taking Viagra who had experienced sudden hearing loss. The FDA found a total of 29 reports which involved patients experiencing 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.
The 29 reports must be seen in relation to the large number of prescriptions for the drugs. 40 million prescriptions of all four drugs have been filled worldwide so far.
Furthermore, there are about 4,000 new cases of sudden hearing loss in the United States each year, according to the U.S. National Institutes of Health.
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