The FDA has approved Tracleer (bosentan) tablets to improve the aerobic abilities of people with a rare but fatal lung disorder called pulmonary arterial hypertension (PAH).
PAH is defined as abnormally high blood pressure in the arteries between the heart and lungs. The condition reduces the ability to exert oneself physically without becoming short of breath. PAH significantly shortens the lire span because it leads to heart failure.
Tracleer blocks the action of endothelin, a substance made in the body that narrows blood vessels and elevates blood pressure. In two clinical trials involving 245 people, treatment with Tracleer significantly increased the six-minute walking distance of those taking the drug, compared to those taking an inactive pill (placebo). In both studies, Tracleer or the placebo was given in addition to any other medications that were prescribed.
The use of Tracleer requires attention to two significant risks: liver toxicity and the drug's potential to damage a fetus. To ensure careful monitoring for these risks, Tracleer will only be available through a direct distribution program from the drug's manufacturer, Actelion Pharmaceuticals US Inc. of South San Francisco, Calif.
Tracleer's warning information states that liver enzyme levels must be measured before initiation of treatment with the drug and monthly thereafter to avoid liver injury. To date, the elevation of liver enzymes caused by Tracleer has been resolved without causing permanent liver damage.
Because of its potential to cause birth defects, Tracleer must not be prescribed to pregnant women. Female patients of childbearing age must take measures to prevent pregnancy, and monthly pregnancy testing will be required. Oral, injected, and implanted contraceptives may not be reliable because Tracleer may alter a woman's metabolism in a way that reduces their effectiveness. So women who take Tracleer must consult with a gynecologist or other doctor knowledgeable about contraceptives.
COPYRIGHT 2002 U.S. Government Printing Office
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