An impotence agent - treats Erectile Dysfunction and Pulmonary Hypertension
FDA Alerts
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.
Do not take sildenafil if you are also using a nitrate drug for chest pain or heart
problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran,
Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide
mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite
("poppers").
Before taking sildenafil, tell your doctor about all other medications you use
for erectile dysfunction, or if you are using any of the following medications:
bosentan (Tracleer);
a blood thinner such as warfarin (Coumadin);
cimetidine (Tagamet, Tagamet HB);
an antibiotic such as erythromycin (E-Mycin, Eryc,
Ery-Tab) or clarithromycin (Biaxin);
HIV medicines such as amprenavir (Agenerase), tipranavir
(Aptivus), darunavir (Prezista), efavirenz (Sustiva), nevirapine (Viramune), indinavir (Crixivan),
saquinavir (Invirase, Fortovase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir
(Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);
an antifungal medication such as itraconazole (Sporanox)
or ketoconazole (Nizoral);
carbamazepine (Tegretol), phenobarbital (Luminal), or
phenytoin (Dilantin); or
rifampin (Rifadin, Rimactane) or rifabutin (Mycobutin).
This list is not complete and there may be other drugs that can interact
with sildenafil. Tell your doctor about all the prescription and over-the-counter medications you
use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.
Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or
tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be
having a serious side effect of sildenafil.
Stop using sildenafil and call your doctor at once if you have any of these serious side
effects:
sudden vision loss;
ringing in your ears, or sudden hearing loss;
chest pain or heavy feeling, pain spreading to the arm or
shoulder, nausea, sweating, general ill feeling;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
vision changes;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
Less serious side effects may include:
warmth or redness in your face, neck, or chest;
stuffy nose;
headache;
upset stomach; or
back pain.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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