Ron
C. Eddins
Waters & Kraus
3219 McKinney Ave.
Suite 3000
Dallas, TX 75204
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In 2000, Americans spent $1.8 billion in diet pills.
Despite a 95% weight loss failure, consumers anxiously awaited the
next "miracle pill" for weight loss. Pharmaceutical companies
have been able to capitalize on the large market of dieting Americans
even despite the numerous deaths and serious adverse
health conditions that resulted from the use of different weight
loss solutions. In 1997, a breakthrough in weight loss pills, called
fen phen was withdrawn from the market after an estimated 6-7 million
Americans took the prescription drug. The drug was linked to serious
and
life-threatening conditions, including heart valve disease and
primary pulmonary hypertension (PPH).
When Meridia was released following fen phen's ban, manufacturer
Abbott Laboratories was quick to
market the new weight loss drug as a preemptive strike against any
diet drug skeptics by saying fen phen and Meridia were very different.
The death of 29 Meridia patients and hundreds of serious Meridia
side effects leave experts wondering if this could have been
prevented. One year before the FDA approval of Meridia, the
FDA advisory committee voted 5-4 that the health benefits of
Meridia did not outweigh the serious risks. The FDA medical officer
who reviewed Meridia recommended it not be approved because the
research indicated the potential heart problems that now affect
a growing number of Meridia patients.
In March, the consumer advocacy group Public Citizen filed a petition
to the FDA asking Meridia to be immediately banned from the market.
Public Citizen is also pushing for a raise in FDA standard for the
approval of diet drugs and to require drug makers to show actual
health benefits rather that relying on short-term studies. If you
or a family member is suffering adverse
health effects from Meridia, we have provided contact
information as well as comprehensive information to better educate
patients of the importance of better weight loss drug safety standards.
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About Meridia
Since the introduction of Meridia there have
been 29 deaths, including 19 due to adverse
cardiovascular effects associated to the weight loss pill. First
approved in 1997, one year after the FDA advisory committee voted
5-4 that the benefits of Meridia did not outweigh the risks Meridia
is available in 70 countries and have been used by 8.5 million people
worldwide. Meridia had received a review from an FDA medical officer
concluding that a non-approval was recommended due to the significant
increase in blood pressure and heart rate in many people. Despite
the opposition from the FDA's own advisory committee and medical
officer, Meridia is still being sold.
read more about Meridia . . .
Meridia Side Effects
Meridia has been associated to potentially fatal and serious
conditions like primary pulmonary hypertension (PPH), cardiac
valve dysfunction, and heart valve disease. These serious Meridia
side effects are listed on Abbott Laboratories'
patient information. Since the FDA approval of Meridia, there have
been 29 deaths and hundred of serious adverse reactions occur in
Meridia patients. These adverse health effects that are being linked
to the use of Meridia are serious and life threatening.
read more about the side effects of
Meridia . . .
Reporting Adverse Meridia Events
The FDA has a program for consumers to report
serious reactions and problems with medical products, including
Meridia weight loss pill side effects,
called MedWatch. If you, or a family member, have suffered the serious
and potentially deadly Meridia side effects, it is encouraged for
you to report it to help prevent any unnecessary future health complications
from occurring.
read
more on reporting adverse Meridia events . . .
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BREAKING NEWS!!
Public Citizen issues public statement criticizing FDA’s failure
to ban Meridia
-September 3, 2003
The Public Citizen consumer group has called upon the FDA once again
for the immediate ban of Meridia diet pill from the market. Originally
calling upon the agency to ban Meridia in a March 2002 petition,
the watchdog group has been critical of the failure to take adequate
safety actions. With “new evidence of a rapidly growing number
of deaths and serious adverse reactions” linked to Meridia,
Public Citizen believes there is “no justification in continuing
to market a drug that provides minimal weight reduction while increasing
the likelihood of injury and death” (citizen.org 9/3/03).
Read Full Article..
Public Citizen Urges Criminal Charges Against Meridia Manufacturer
Abbott Laboratories
-May 21, 2002
Public Citizen has already petitioned the FDA
for the immediate removal of Meridia weight loss pill, and on May
21, 2002, the group said they had obtained a report of an FDA inspection
of Abbott facilities in Abbott Park, Illinois. Read
More here...
Abbott Laboratories assures safety of Meridia
-March 20, 2002
After Public Citizen issued a petition to the FDA remove Meridia from
the U.S. market, Abbott Laboratories, Meridia's maker, issued a statement
claiming the petition was based on incorrect conclusions. Abbott believes
that Public Citizen has not considered the serious medical condition
that obesity poses and that removal of Meridia from the market would
be a large disfavor to every American that suffers from obesity.
Read more Meridia news stories . . . |
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March 19, 2002 Public
Citizen files a petition asking the FDA to immediately ban
Meridia weight loss pills from the market.
March 19, 2002 Public
Citizen's petition concluding the benefits of Meridia does
not outweigh the risks.
Notable
Meridia Quotes
"For simply across-the-board use,
I think that you can't endorse it, but for use in an appropriately
screened populations of people, absolutely, but more information
is really going to be needed."
(CNN, 9-26-96)
-Dr. John Flack, FDA consultant
after Meridia was sent back for more research in 1996
"We still have some concerns."
(Detroit News, 11-29-97)
-FDA's Dr. James Bilstand at the
time of the 1997 FDA approval of Meridia
"As we saw with Redux, there's a tremendous pent-up market
in weight loss. I think- I hope the public has learned there
is a danger in prescribing this to individuals who do not
fit the criteria."
(AP, 2-13-98)
-Morgan Downey, executive director
of the American Obesity Association
"Based on 50 reports of adverse events
during treatment, the Pharmaceutical Commission decided that
the beneficial effects of the drug must be re-evaluated."
(Yahoo, 3-7-02).
-Italy's Pharmaceutical Commission
recommending the suspension of sibutramine
"The drug should have never been
put on the market- the advisory committee and the physician
in charge of the drug both recommended against approval. This
is a mistake that is being corrected. The drug is just not
going to survive much longer."
(ABC News, 3-19-02)
-Sidney Wolfe, Public Citizen Director
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