In the EU Tracleer(R) is indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Tracleer(R) has been shown to improve hand function (i.e. dressing and hygiene) in patients with scleroderma-induced digital ulcers.
Requires attention to two significant safety concerns: Potential for
serious liver injury (including rare cases of liver failure and unexplained
hepatic cirrhosis in a setting of close monitoring) -- Liver monitoring of
all patients is essential prior to initiation of treatment and monthly
thereafter. High potential for major birth defects -- Pregnancy must be
excluded and prevented by two forms of birth control; monthly pregnancy
tests should be obtained. Because of these risks, Tracleer(R) is only
supplied through a controlled distribution.
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symptomatic pulmonary arterial hypertension with bosentan (EARLY
study): a double-blind, randomised controlled trial. The Lancet 2008;
2. Channick RN, Simonneau G, Sitbon O et al. Effects of the dual
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4. Sitbon O, Humbert M, Jais X et al. Long-term response to calcium
channel blockers in idiopathic pulmonary
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