FDA ISSUES STIFFER WARNINGS FOR ED

Pharmacy Times, Volume 0, 0

New labeling onthe the erectile dysfunctiondrugs Cialis(tadalafil tablets),Levitra (vardenafilHCl), and Viagra(sildenafil citrate) willwarn men of possiblehearing lossresulting from theseproducts.

The new FDA warnings were developedafter what agency officials described as a?very small number? of patients whoexperienced sudden loss of hearing aftertaking the drugs.

FDA said it plans to require the samelabel warnings for Revatio (sildenafil citrate),for pulmonary arterial hypertension.The FDA is currently working with thesponsor to revise the label for Revatio.