Audience: Urologists, other healthcare professionals, consumers
[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.
[October 18, 2007 - Viagra Information page - FDA]
[October 18, 2007 - Viagra label - Pfizer]
[October 18, 2007 - Cialis Information page - FDA]
[October 18, 2007 - Cialis label - FDA]
[October 18, 2007 - Levitra Information page - FDA]
[October 18, 2007 - Levitra label - FDA]