Viagra, Levitra, Cialis:
Possible Sudden Hearing Loss

October 18, 2007 - FDA has approved labeling changes for the phosphodiesterase Type 5 (PDE5) inhibitor class of erectile dysfunction (ED) drugs, Cialis, Levitra, and Viagra. This change is being implemented to display more prominently the potential risk of sudden hearing loss.  FDA plans to issue a Healthcare Professional Sheet that will provide additional information about this potential risk.

The FDA is making this announcement as part of its ongoing commitment to inform consumers of emerging health issues with marketed drugs.  The Agency believes that by making this announcement it will better inform consumers taking these drugs of this possible risk and guide them on what to do if they experience sudden problems with their hearing.

A case report in the published literature of sudden hearing loss in a male patient taking Viagra prompted FDA to search the Adverse Event Reporting System (AERS) for postmarketing reports of hearing impairment for all PDE5 inhibitors. FDA found a total of 29 reports of sudden hearing loss, both with and without accompanying vestibular symptoms (tinnitus, vertigo or dizziness), in strong temporal relationship to dosing with Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenadil). Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class.

Hearing loss is very commonly reported in an aging population, especially in patients with risk factors for erectile dysfunction.  However, sudden hearing loss is an uncommon event at any age.  It is not known whether age was a factor in the cases of sudden hearing loss reported in temporal relation to use of the PDE5 inhibitors.

In approximately one third of the cases of sudden hearing loss, the event was temporary.  In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.  In almost all cases, the hearing loss was one-sided.

Patients taking Cialis, Levitra or Viagra for the treatment of ED who experience sudden hearing loss should immediately stop taking the drug and also seek prompt medical attention.

PDE5 inhibitors are safe and effective for the treatment of ED when taken according to the labeling.  However, all drugs carry risks and you should discuss any concerns you have regarding taking these products with your healthcare provider.

Article from FDA New Release, October 18, 2007, "Questions and Answers about Viagra, Levitra, Cialis, and Revatio: Possible Sudden Hearing Loss"

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