The FDA announced today that is expanding the warning labels on erectile dysfunction (ED) drugs. The warning will force pharmaceutical makers of the ED drugs to display the potential risk of sudden hearing loss more visibly. They will also be required to provide a guide to consumers and what steps to take should they experience sudden hearing problems.
The new warning covers Viagra from Pfizer Inc. ( NYSE:PFE), Cialis from Eli Lilly & Co. (NYSE:LLY), and Levitra from Bayer Health Care Pharmaceuticals. 
Also included in the labeling changes is Revatio, which is used to treat pulmonary arterial hypertension due to the fact that it contains some of the same components as the ED drugs.
The warning comes after the FDA received reports of 29 cases of sudden hearing loss, with or without ringing in the ears. In most of those cases the loss of hearing was in one ear and in 1/3 of the cases the loss was temporary.
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
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