Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (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 sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#PDE5, http://www.fda.gov/cder/consumerinfo/viagra/default.htm, http://www.fda.gov/cder/foi/label/2007/020895s027lbl.pdf, http://www.fda.gov/cder/drug/infopage/cialis/default.htm, http://www.fda.gov/cder/foi/label/2007/021368s012lbl.pdf, http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm and http://www.fda.gov/cder/foi/label/2007/021400s010lbl.pdf.