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Contact a Miami Bosentan Lawyer
Defective Drug Side Effects Topics
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Bosentan was FDA approved November 20, 2001 as a treatment for pulmonary arterial hypertension (PAH). Manufactured by Actelion the tablets were intended to improve the exercise ability of patients due to the abnormally high blood pressure in the arteries located between the heart and lungs in the first oral medication for PAH. This condition drastically decreases an individual’s ability for physical exertion because they suffer from a shortness of breath. Associated to the use of diet drugs, an estimated 6-7 million Americans took Fen Phen prior to the recall.
Studies performed on diet drugs, including recalled drugs Fen Phen, Redux, and Pondimin, showed while pulmonary hypertension is a rare occurrence affecting very few people, 1 in 20,000 diet drug users became affected by pulmonary hypertension. Researchers later found this estimation to be conservative. The introduction of Bosentan allows the body to block the action of endothelin that has been found to exist in high concentrations in the plasma and lungs of PAH patients. The high concentration of endothelin is a possible cause of the disease because it narrows blood vessels and elevates blood pressure.
Based off of two randomized, placebo-controlled clinical trials involving 245 patients, the FDA and the Cardiovascular and Renal Drugs Advisory Committee determined Bosentan was an effective treatment for pulmonary hypertension. Bosentan showed a significant improvement in pulmonary hypertension patients’ walking distance with treatment that remained for up to seven months. There are safety issues associated to Bosentan, as with any drug treatment. There is a black box warning on Bosentan’s drug labeling warning of liver toxicity and fetal damage risk. Due to the serious implications of Bosentan drug risks, the pulmonary hypertension treatment was made available only through a direct distribution program from Bosentan manufacturer Actelion Pharmaceuticals.
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