Audience: Urologists, other healthcare professionals, consumers
[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or lack of hearing pursuing the usage of PDE5 inhibitors Viagra, Levitra, Cialis for that management of impotence problems, and Revatio for the treatment of pulmonary arterial hypertension. In most cases, the sudden hearing difficulties was coupled with tinnitus and dizziness. Medical follow-on these reports was often limited that makes it difficult to determine whether losing hearing was linked to using on the list of drugs, the actual problem or other risk factors for the loss of hearing, a combination of these factors or other elements. The PRECAUTIONS and Effects parts of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is handling the manufacturer to revise the labeling for Revatio.