Sitaxsentansodium.PDF

This document posted Recommendations and Reasons July 2010 Committee to Evaluate Drugs (CED) On December 15, 2010, Pfizer Canada announced that it is voluntarily withdrawing THELIN? (sitaxsentan sodium) from the market due to Sitaxsentan sodium concerns about hepatotoxicity. For details, please see: http://www.hc- sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/thelin_2_hpc-cps- Product: eng.php. SITAXSETAN SODIUM (Thelin?) 5mg and 10mg tablets Highlights of Recommendation: Background: Class of drugs: Endothelin receptor antagonist ? Sitaxsentan is an oral drug used to treat Pulmonary arterial hypertension (PAH) is a pulmonary arterial hypertension (PAH). disabling and typically progressive disease Indication: ? The clinical trials demonstrated that that occurs when dangerously high blood Treatment of pulmonary arterial sitaxsentan improves exercise capacity pressure builds up in the blood vessels hypertension based on the six-minute walk distance that lead from the heart to the lungs. The Manufacturer: Pfizer Canada Inc. when compared to placebo. However, small blood vessels in the lungs narrow sitaxsentan has not been shown to improve and their walls thicken, causing the clinically important outcomes (such