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Archived: Bosentan (Tracleer®)


Recommended for restricted use within NHS Scotland.


This medicine was approved by EMEA under the accelerated licensing process, thus evidence of its efficacy is limited. Bosentan may be a potentially useful alternative to epoprostenol for patients with Grade III pulmonary arterial hypertension. It offers major advantages over epoprostenol in its ease of administration. However, there are currently scant data on the effectiveness of these products on patient survival. The hepatotoxicity and teratogenicity of Bosentan have led the EMEA to recommend post-marketing surveillance and the company operates this as a controlled release programme. The costeffectiveness of Bosentan is impossible to estimate at present, and may be low. Bosentan should only be prescribed for patients who are treated in specialist centres run by physicians experienced in the management of these disorders.

Drug Details

Drug Name: Bosentan (Tracleer®)
SMC Drug ID: 32/03
Manufacturer: Actelion Pharmaceuticals UK Ltd
Indication: Pulmonary arterial hypertension
BNF Category:
Sub Category: 2.5 Hypertension and heart failure
Submission Type: Full submission
Status: Restricted
Date Advice Published: 7 March 2003

Current Advice

Non submission 10 November 2008