FDA has received about 30 reports of sudden hearing loss in patients taking a class of erectile dysfunction drugs called PDE5 inhibitors This class of drugs includes Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil). The problem was sometimes accompanied by tinnitus, vertigo, or dizziness. In most cases the hearing loss involved one ear, and about a third of the time it was temporary.
Medical follow-up information was often limited for the reported cases, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors.
FDA has asked the manufacturers of these erectile dysfunction drugs to display the risk of hearing loss more prominently in the labeling, and to guide patients on what to do if they experience hearing problems while they are on the drugs. The revised label will advise clinicians to let patients know that sudden hearing loss may be due to the drug, and to stop taking the drug and seek medical attention if they experience any sudden decrease or loss of hearing.
Another PDE5 inhibitor, Revatio, also contains sildenafil, the same active ingredient as in Viagra. However, Revatio is used to treat pulmonary arterial hypertension rather than erectile dysfunction. FDA is working with the manufacturer of this drug to revise its labeling, too. Because pulmonary hypertension is a life-threatening condition, patients taking Revatio should not stop taking their medication, but should be instructed to contact their physician promptly if they experience sudden hearing loss.
FDA MedWatch Safety Alert. Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil).
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