FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
-FDA News
10/22/2007 - TheFDA is requiring labeling changes for erectile dysfunction drugs in the phosphodiesterase Type 5 (PDE5) inhibitor class, which includes Cialis, Levitra and Viagra, to display prominently the potential risk of sudden hearing loss.
The agency plans to require the same changes in labeling for the drug Revatio, a PDE5 inhibitor used to treat pulmonary arterial hypertension.
The FDA asked manufacturers of these drugs to revise product labeling after a small number of users reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness, the agency said.
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