FLOLAN - TRACLEER
Flolan Is used to treat
people who have been diagnosed with Primary Pulmonary Hypertension also known
as PPH. Flolan first
approved in October 1995 by the FDA for use in cases of symptomatic PPH, Flolan
was first available for use in the United States in January 1996. It must be
continuously infused into the heart as prostacyclin lasts only for several
minutes in the circulation. Flolan recipients must have a permanent central
venous catheter implanted which is attached to an external portable infusion
pump. The patient receives extensive training in the proper procedures for
changing the catheter, cleaning the infusion site and measuring their Flolan
dosages. Flolan or Epoprostenol is a form of the molecule prostaglandin, a
naturally occurring substance in the body that causes blood vessels to dilate
open up in the lungs and throughout the body. Flolan is used to ease the
symptoms of PPH by keeping blood vessels dialated to relieve the high blood
pressure between the lungs and the heart. Flolan may also aid in the prevention
of blood clots.
Since the Flolan only stays
in the body 3-5 minutes, it must be given on a continuous basis without interruption.
requires skilled handling and must be kept at a controlled temperature and
be protected from light. Flolan costs about $100,000 annually, but it
appears to be worth every penny as it has been found to increase life
expectancy of PPH patients by up to 5 years.
Tracleer tablets is currently
PPH patients to improve the exercise and function level. Tracleer (Bosentan)
was approved by the FDA on November 20, 2001, as the first treatment for
PPH in a
pill form. According to the FDA, Tracleer blocks the action of endothelin (a
substance produced in the human body) which narrows blood vessels and elevates
blood pressure. Although endothelin is present in healthy people, high
concentrations of the hormone have been found in the plasma and lungs of
patients with PPH, suggesting that endothelin may be capable of causing the
disease. Designed to improve the exercise ability of patients with PPH, Tracleer
became available in the US in December 2001.
FDA hearing, Actelion presented data from two successful Phase III pivotal
studies that showed improved exercise capacity of patients. The first trial was
a double-blind, placebo-controlled study involving 32 patients at six centers
(five in the U.S. and one in France). At 12 weeks, patients in the Tracleer
group demonstrated a 20% increase in exercise ability compared to placebo in the
standardized six-minute walk test (p=0.018). Tracleer patients improved their
timed walk distance by a mean of 72 meters, and there was a 40% net difference
in cardiac output in favor of Tracleer compared to placebo.
to the FDA, the use of Tracleer by persons with pulmonary hypertension may
two significant risks-liver toxicity and
Tracleer's potential damage to a fetus. Consequently, Tracleer will not be
available in commercial pharmacies, but will be available only through a direct
distribution program from the drug's manufacturer. Unlike Flolan, that must be
given intravenously and in a continuous manner, Tracleer can be taken in pill
form.Tracleer does not cure PPH, nor does it slow it's progression.
Tracleer does however, give most patients a better quality of life
than they would otherwise have without it and not as dependant upon intravenous
therapy. The cost of Tracleer, a
twice-daily pill is estimated at about $30,000 per year per patient.
PPH DRUG THERAPY see below:
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
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.