FDA approves labeling changes for Cialis, Levitra, Viagra

October 22, 2007

FDA announces revisions to labels for Cialis, Levitra, and Viagra.

The FDA has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis (tadalafil, Lilly), Levitra (vardenafil, Bayer), and Viagra (sildenafil, Pfizer) 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. In addition, the FDA plans to require the same changes in labeling for the drug Revatio (sildenafil, Pfizer), another member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH), a serious medical condition in which continuous high blood pressure in the arteries of the lungs weakens the heart muscle and often leads to right heart failure and death. For more information, visit