Hearing loss class labeling for ED drugs

Executive Summary

FDA is updating labeling for phosphodiesterase type 5 inhibitors to highlight the risk of sudden hearing loss, though the agency is not asserting a causal link. The drug class includes the erectile dysfunction drugs Cialis, Levitra and Viagra and the pulmonary arterial hypertension treatment Revatio (sildenafil citrate). Viagra (sildenafil citrate) labeling previously listed "deafness" and "tinnitus" in the Adverse Reactions section, but Levitra (vardenafil) and Cialis (tadalafil) labeling did not include those risks. Now labeling will be consistent across the PDE-5 inhibitor class, including the addition of information about hearing loss in the Precautions section. FDA identified 29 postmarketing reports of sudden hearing loss in its Adverse Events Reporting System, the agency says Oct. 19...