FDA Announces Revisions to Labels for Cialis, Levitra, and Viagra

The US Food and Drug Administration announced on October 18, 2007 that it has approved labeling changes for the erectile dysfunction drugs in the phosphodiesterase class that includes Cialis, Levitra, and Viagra. This is due to the potential risk of sudden hearing loss. The same labeling changes are planned for the drug Revatio, also a member of this class. Revatio is used to treat pulmonary hypertension, a very serious condition characterized by an increased pulmonary arterial pressure that can eventually lead to death.  Patients using Cialis, Levitra, or Viagra  should stop treatment and contact their primary care provider if they experience any sudden hearing loss. The FDA does not recommend patients using Revatio to abruptly stop their therapy, but they should contact their primary care physician if any sudden problems with treatment occur. Reports from the FDA found 29 cases associated with sudden hearing loss, that included ringing in the ears, dizziness, and vertigo. Although a causal relationship was not definitively proven, the strong relationship between using these agents and sudden hearing loss provides a rationale for the labeling changes to occur. Most reports found that the loss of hearing was confined to one ear. Physicians should make patients aware of the potential problems this class of drugs can cause. Pharmacists should counsel patients receiving these drugs about the new labeling changes.

Prepared by Ed Posti, Doctor of Pharmacy Candidate