BOSENTAN - A Miracle Drug for Primary Pulmonary
Hypertension (PPH) Patients
Bosentan -Tracleer is the
first oral endothelin receptor antagonist for pulmonary hypertension (PAH).
Previous to its
availability, patients would try oral vasodilators (such as calcium channel
blockers) or intravenous Flolan Bosentan tablets work by blocking the
hormone endothelin that has been found to exist in a higher level with
pulmonary hypertension and is harmful to the lung and pulmonary arteries.
Bosentan works by lowering the levels of a naturally occurring vasoconstricter
called endothelin in the blood. A lower endothelin level helps to reverse
the effects of hypertension created because the damaged lung and pulmonary
arteries have created a blood flow resistance.
The Bosentan product information has a black box
warning about potential liver toxicity and potential to cause major birth
defects. At least 3-fold elevations of liver enzymes (aminotransferases; ALT,
AST) above the upper limit of normal are seen in about 11% of patients. These
liver enzymes (i.e. liver function tests or LFTs) should be measured prior to
initiation of treatment and then monthly.
Bosentan Adverse Reactions & Side
Adverse reactions reported in clinical testing of Bosentan
Tracleer include (but are not limited to) the following:
- Nasopharyngitis (inflammation of the nose and
- Edema, lower limb
Women who are pregnant,
or who may become pregnant, should not take Bosentan Tracleer due
to the risk of birth defects. Additionally, patients receiving Tracleer
should undergo monthly
liver monitoring to ensure that proper enzyme levels are maintained.
Bosentan has a FDA pregnancy category
X rating. Tracleer Bosentan is very likely to produce major birth defects
if used by pregnancy women. Pregnancy must be excluded before the start of
treatment and prevented thereafter by the use of a reliable method of
contraception. Hormonal contraceptives, including oral, injectable and
implantable contraceptives should not be used as the sole means of contraception
because these may not be effective in patients receiving Tracleer.
Co-administration of Bosentan / Tracleer and cyclosporine is
contraindicated because there may be markedly increased plasma concentrations of
Tracleer. Co-administration of Tracleer and glyburide is contraindicated because
of the increased risk of liver enzyme elevations.
How Bosenten Works
Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by
binding to ETA and ETB receptors in the endothelium and vascular smooth
muscle. ET-1 concentrations are elevated in plasma and lung tissue of patients
with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in
this disease. Bosentan is a specific and competitive antagonist at endothelin
receptor types ETA and ETB . Bosentan has a slightly higher affinity for ETA
receptors than for ETB receptors (from Tracleer Prescribing Information).
PPH- LAWSUITS - LEGAL OPTIONS FOR PPH
you or a loved one have been diagnosed with Primary Pulmonary Hypertension (PPH),
then you may have a right to file a individual legal action against the
manufacturers of the diet pills or other products that caused your PPH. Due to
the nature of this serious and devastating disease process, PPH patients are
urged to contact an attorney immediately after he or she has been informed of
their Primary Pulmonary Hypertension diagnosis. Many important legal issues
need to be addressed early after a PPH diagnosis, that can affect the
outcome of the PPH litigation. Call us for a Free Confidential Consultation.
Talk with a Board Certified Personal Injury Trial Lawyer about your legal
rights of a PPH claim against the diet drug industry and others. No Fees or
Expenses Charged unless we make a Recovery for You.
Call Us Toll Free at 1-800-883-9858
or 1-800-468-4878 or E-mail
us your questions on Free
Case Evaluation Form.
also see discussions of other PPH Drugs