FDAnews Drug Daily Bulletin

The FDA is updating labeling for a class of erectile dysfunction drugs to display the potential risk of sudden hearing loss more prominently.

Drugs in the class known as phosphodiesterase Type 5 (PDE5) inhibitors include Eli Lilly’s Cialis (tadalafil), Bayer and GlaxoSmithKline’s Levitra (vardenafil HCl) and Pfizer’s Viagra (sildenafil citrate). The FDA also is requiring the labeling changes for Pfizer’s Revatio (sildenafil citrate), a PDE5 inhibitor used to treat pulmonary arterial hypertension.

Twenty-nine patients taking PDE5 inhibitors reported sudden hearing loss, sometimes with ringing in the ears and dizziness, according to reports in the FDA’s Adverse Event Reporting System. Most of the cases involved hearing loss in one ear.

Hearing loss was temporary in approximately one-third of the cases, but the other cases had ongoing hearing loss or did not provide information on the outcome.

More information on the labeling change can be seen at www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm.