MONDAY, Oct. 22 (HealthDay News) -- The U.S. Food and Drug Administration is requiring labeling changes for erectile dysfunction drugs such as Viagra, Levitra and Cialis to more clearly display the potential risk of sudden hearing loss on their packaging, due to recent reports of a small number of cases of sudden hearing loss associated with the use of phosphodiesterase type 5 (PDE5) inhibitors.
A case report of a man who developed sudden hearing loss while taking Viagra, published in the April 2007 issue of the Journal of Laryngology & Otology, prompted the FDA to search for similar reports associated with PDE5 inhibitors. A review of the FDA's Adverse Events Reporting System identified 29 postmarketing cases of sudden hearing loss, both with and without tinnitus, vertigo and dizziness. The hearing loss was unilateral in most cases, and temporary in one-third of cases.
Patients taking Viagra, Levitra and Cialis who experience sudden hearing loss should immediately stop taking the drug and seek medical attention promptly. Patients who experience this symptom while taking Revatio, a PDE5 inhibitor used in the treatment of pulmonary arterial hypertension, should continue taking the medication but consult with their physician for further evaluation.
"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, in a statement.
More Information
