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The History of Phentermine
Phentermine is
an appetite suppressant that is commonly
prescribed and accounts for 50% of appetite
suppressant prescriptions. Partly it
is because Phentermine is significantly
cheaper than any other FDA-approved
diet drug such as Meridia and Xenical.
The Food and Drug Administration (FDA)
first approved Phentermine as an appetite
suppressant, for the short-term treatment
of obesity, in 1959. Phentermine resin
United States, also became available
in 1959 with Phentermine Hydrochloride
following in the early 1970s
Presently Phentermine
is available as a generic medication,
known as phentermine, and is also sold
in the US under the brand names - Ionamin®
(Medeva Pharmaceuticals) and Adipex-P®
(Gate Pharmaceuticals). It was sold
previously under the name Fastin®, produced
by King Pharmaceuticals for Smith-Kline
Beecham. Smith-Kline Beecham removed
Fastin from the marketplace in December
1998.
Phentermine being
an older drug has no new efficacy trial
documentation available. With one notable
exception, several trials were conducted
on a Phentermine / Fenfluramine combination
treatment during the early to mid 1990s.
Passing Trends : FEN-PHEN (or Phen-Fen)
and Dexfen-Phen
Fen-Phen is a
cocktail, of Fenfluramine (Pondimin
- Fen) and Phentermine (Phen). Fenfluramine
obtained FDA approval for short-term
treatment of obesity in 1973. Jointly,
Phentermine and Fenfluramine fashioned
a powerful diet drug cocktail that the
FDA has never approved. Usually once
the FDA has approved a drug, doctors
are allowed to prescribe it at will.
Though the Fen - Phen cocktail was considered
“off-label”.
In 1992 a study
was published a citing Fen-Phen as a
method more effective than dieting or
exercise for weight reduction in the
chronically obese. Unlike the earlier
production of speed-laden drugs for
dieting Fen-Phen seemed to be free from
side effects. 1996 witnessed 6.6 million
prescriptions of the Fen-Phen cocktail
in the U.S.
Dexfen-Phen is
the combination of Dexfenfluramine or
Redux (Dexfen) and Phentermine (Phen).
Dexfenfluramine was approved by the
FDA in 1996 as an appetite suppressant
for the maintenance and management of
obesity. As with Fen-Phen; Dexfen-Phen,
became a sensation overnight.
Neither of these
combinations was ever tested for safety.
The Mayo Clinic
had reported twenty four cases of valvular
heart disease by the summer of 1997.
In all cases the people had used the
Fen-Phen cocktail. This unusual amount
of cases of heart valve disease in the
Fen-Phen users was suggestive of a correlation
between use of Fen-Phen and heart valve
disease.
The FDA released
a Public Health Advisory to report findings
from the Mayo Clinic on July 8, 1997.
(also published in the August 28 issue
of the New England Journal of Medicine).
Click
here
to see the FDA Health Advisory, but
continued to receive reports of heart
disease, also from patients who had
only taken Dexfenfluramine or Fenfluramine
and not the cocktail.
Additional evaluations
made on patients using either Fenfluramine
or Dexfenfluramine, indicated that approximately
30% presented with abnormal heart valve
results. This amount is far more than
should be expected in any abnormal test
results, and suggests that Fenfluramine
and Dexfenfluramine were very likely
the cause of the valvular heart disease
and Primary Pulmonary Hypertension (PPH).
These findings
were alarming and prompted the FDA to
respond. In September 1997 the FDA requested
that drug manufacturers voluntarily
withdraw both these drugs. Simultaneously,
it was recommended by the FDA that patients
taking Fenfluramine or Dexfenfluramine
should stop taking them. Please click
here.
For FDA September
1997 statement regarding this withdrawal.
However the FDA
did not, request the withdrawal
of Phentermine, the third drug
mixed up with the cocktails.
PHEN-PRO
The most modern
cocktail including Phentermine is "Phen-Pro"
- the "Pro” for Prozac. The following
antidepressants: Celexa ,Zoloft, Trazadone,
Luvox, or Effexor may be used instead
of Prozac. The use of antidepressant
for the Phen-Pro cocktail is not related
to depression. This cocktail has become
effective as the effect of Phentermine,
if used alone, becomes less over time.
The Phen-Pro cocktail lets Phentermine
provide an enhanced result over longer
periods of time. This cocktail does
not seem to cause the same problems
resulting from the use of Fen-Phen.
The Phentermine / Prozac cocktail is
also considered "off-label", and the
FDA, does not approve its use.
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