FDA approves label change to reflect potential hearing loss from E.D. drugs

WASHINGTON The Food and Drug Administration has approved labeling changes for erectile dysfunction drugs to add a new warning for the potential risk of sudden hearing loss.

The drugs included are Cialis, Viagra, Levitra and Revatio, which is used to treat pulmonary arterial hypertension. Patients taking any of the drugs besides Revatio are being told to discontinue taking the medication and contact their prescriber immediately if they begin experiencing any type of hearing loss.

In most cases discovered, the hearing loss is in one ear and it was either partial or complete loss of usual hearing. About one third of the cases were temporary and as of now the hearing loss continued in the other reported cases.