FDA revises labels for ED drugs Viagra, Levitra and Cialis to reflect side effect

The US Food and Drug Administration has approved labeling changes for erectile dysfunction drugs in the class of compounds known as phosphodiesterase type-5 inhibitor that includes Pfizer's blockbuster Viagra (sildenafil), Johnson & Johnson's Cialis (tadalafil) and Bayer's Levitra (vardenafil), which is co-marketed with Schering-Plough and GlaxoSmithKline, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they should experience sudden problems with their hearing.

Also changes for Revatio

In addition, the FDA plans to require the same changes in labeling for the drug Revatio (sildenafil), also a member of this drug PDE-5 inhibitors class, but which is indicated for the treatment of pulmonary arterial hypertension. 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 agency notes.