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FDA ISSUES STIFFER WARNINGS FOR ED

Published Online: Saturday, December 1, 2007   [ Request Print ]

New labeling on the the erectile dysfunction drugs Cialis (tadalafil tablets), Levitra (vardenafil HCl), and Viagra (sildenafil citrate) will warn men of possible hearing loss resulting from these products.

The new FDA warnings were developed after what agency officials described as a ?very small number? of patients who experienced sudden loss of hearing after taking the drugs.

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

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