FDA lifts alpha-blocker contraindication for PDE-5 inhibitor

May 5, 2005

The FDA has authorized a label change for the phosphodiesterase type-5 inhibitor tadalafil (Cialis), removing a contraindication on the use of the drug with alpha-blockers.

The FDA has authorized a label change for the phosphodiesterase type-5 inhibitor tadalafil (Cialis), removing a contraindication on the use of the drug with alpha-blockers. Tadalafil had been contraindicated for use in men taking alpha-blockers, with the exception of tamsulosin hydrochloride (Flomax). Under the label change, the contraindication has been replaced with precautionary language. Alpha-blockers include alfuzosin hydrochloride (Uroxatral), doxazosin mesylate (Cardura), terazosin hydrochloride (Hytrin), prazosin hydrochloride (Minipress), and tamsulosin.

"When Cialis is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with Cialis, and Cialis should be initiated at the lowest recommended dose," the label states.