Viagra, Levitra, Cialis, and Revatio May Cause Sudden Hearing Loss

According to a press release today from the U.S. Food and Drug Administration , makers of the ED, or erectile dysfunction, medications are being required to make some label changes to include a more prominent warning of the possible risk of hearing loss and what the consumer should do if they should experience a sudden problem with their hearing.

Some examples of ED medications in this drug class are Viagra (sildenafil), Levitra (vardenadil), Cialis (tadalafil). Patients using any of these drugs should stop taking the medication immediately and seek prompt medical help if they experience a sudden hearing loss.

Another medication within the same drug class of a phosphodiesterase type 5 (PDE5) inhibitors, is called Revatio (sildenafil). The FDA is also requiring them to change their labeling to include a warning about hearing loss. This drug is used to treat pulmonary arterial hypertension (PAH). This is a serious medical condition in which the heart muscle is weakend by high blood pressure in arteries of the lungs. This could possibly lead to heart failure and death.

A small number of patients using Revatio had reported that they had some hearing loss along with dizziness and ringing of the ears. Patients using Revatio should continue using the drug, but contact their physician for further evaluations. Because Revatio is a treatment drug for a potentially life threatening condition, the FDA recommends that they continue taking Revatio and contact their physician should they experience any hearing problems.

A case report of a man who was taking Viagra and experienced hearing loss was listed in the April of 2007 issue of Journal of Laryngology & Otology. This called the problem to the attention of the FDA and they began to search their Adverse Events Reporting System for reports of hearing loss and PDE5 inhibitors. The findings showed a total of 29 postmarketing reports of sudden hearing loss, with or without a ringing in the ears, vertigo, or dizziness. Most reported cases involved a partial or complete hearing loss in one ear only. In one third of the cases the hearing loss was only temporary. In the remainder of the cases the hearing was ongoing at the time of the report findings.

All of these drugs that are listed are safe and effective when used according to the instructions on the labels. But with all drugs there are risks. Be sure to talk to your physician if you have any problems while taking these medications.

SOURCE : FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01730.html

SOURCE : Questions and Answers about Viagra, Levitra, Cialis, and Revatio:
Possible Sudden Hearing Loss
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm