FDA Revises Cialis, Levitra, Viagra Labels

The U.S. Food and Drug Administration has revised the labeling of the erectile dysfunction drugs Cialis, Levitra and Viagra to warn of possible hearing loss.

The FDA said the labels now will offer inform people of the potential risk of sudden hearing loss, and guide them on what to do if they experience sudden problems with their hearing.

In addition, the FDA said it plans to require the same changes in labeling for the drug Revatio, which is used to treat pulmonary arterial hypertension — a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA said it asked manufacturers to revise product labeling after a very small number of patients reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

Patients taking Cialis, Levitra or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication, but should contact their health care provider for further evaluation.