FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

Labeling Revised for Erectile Dysfunction Drugs

Labeling changes that give more prominence to the potential risk of sudden hearing loss have been approved for erectile dysfunction drugs in the class that includes Cialis, Levitra, and Viagra. The revised labeling, approved by FDA on Oct. 18, 2007, will also guide patients on what to do if they experience sudden hearing problems.

FDA also plans to require the same labeling changes for Revatio, a drug to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle.

Cialis, Levitra, Viagra, and Revatio are part of a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. FDA asked manufacturers to revise product labeling after a very small number of patients taking PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

FDA recommends

• Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention.
• Patients taking Revatio who experience hearing loss should continue taking their medication, but should contact their health care provider for further evaluation. Patients should NOT abruptly stop taking this medication because PAH is a potentially life-threatening condition.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01730.html

Label Revisions
http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm

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

Date Posted: October 29, 2007

FDA Consumer Health Information
Consumer Updates archive

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff