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.
Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss.
Stop using sildenafil and get emergency medical help if you have sudden vision loss.Sildenafil relaxes muscles and increases blood flow to particular areas of the body.
Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.
Sildenafil may also be used for other purposes not listed in this medication guide.
Before taking sildenafil, tell your doctor if you are allergic to any drugs, or if you have:
heart disease or heart rhythm problems;
a recent history (in the past 6 months) of a heart attack, stroke, or heart rhythm disorder;
high or low blood pressure;
a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
a bleeding disorder such as hemophilia;
retinitis pigmentosa (an inherited condition of the eye);
a physical deformity of the penis (such as Peyronie's disease); or
if you have been told you should not have sexual intercourse for health reasons.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take sildenafil.
Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss.Related Learning Centers |
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