FDA Issues an Information for Healthcare Professionals Sheet for Viagra, Levitra, and Cialis

-PharmaLive

11/14/2007 - FDA has received reports of cases of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, and Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness.

Medical follow-up information was often limited for the cases reported postmarketing, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors.

Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In response to a request from FDA, the manufacturers of Viagra, Levitra and Cialis have revised the labeling for these products to address the potential risk of sudden hearing loss and to guide patients on what to do if they experience sudden problems with their hearing.

FDA is currently working with the sponsor to revise the labeling for Revatio. The approved revised labeling for Viagra, Levitra and Cialis includes a new Precaution and updated Adverse Reactions sections.


Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Viagra side effects. If you or a loved one have suffered as a result of Viagra side effects you may be entitled to compensation. Click here for a free, confidential case evaluation.