Sibutramine hydrochloride monohydrate, manufactured and marketed
for the treatment of obesity by
Abbott Laboratories, is more commonly known by the name
Meridia®. The primary mode of action of Meridia
is to suppress brain chemicals that effect appetite.
This affect results in weight loss according to the manufacturer.
Meridia
became popular even though it was not considered as effective
for weight-loss as the combination of fenfluramine and phentermine
(phen-fen). This is because the withdrawal of fenfluramine
from the market made the sale of phen-fen illegal. Its popularity
also increased even though weight-loss from Meridia use is
considered moderate (5% to 10% of total body weight). Additionally,
Meridia use continued to rise despite the fact that an FDA
advisory committee voted five to four that the risks of Meridia
use outweighed the benefits. A risk of great concern to the
FDA is the potential for significant increase in blood pressure
and heart rate in some patients, which could become life threatening.
1 An FDA medical officer even stated that "Meridia
should never have been approved. The clinical tests clearly
show that the risks of death and serious injuries greatly
outweigh its minimal effectiveness." In the end,
none of these risks or other concerns have discouraged widespread
Meridia use.
~ 8.6 million people worldwide have taken Meridia
Although there has been some concern over the use of Meridia,
it is estimated that to date over 8.6 million people worldwide
have used Meridia, with 20,000 prescriptions filled weekly
in the United States alone.
2 However, on March
19, 2002, the consumer advocacy group Public Citizen
petitioned the FDA to remove Meridia from the market.
The petition states that Meridia has been associated with
29 deaths. Of these, nineteen deaths were determined to be
related to cardiovascular problems. Problems have also been
observed in several other countries: use of Meridia suspended
in Italy because of two cardiovascular deaths; use of Meridia
in France and Great Britain under review because of over 400
adverse health reports, including two deaths in Britain and
over 110 serious health reports in those countries. This information,
with FDA concerns and its 'minimal' effectiveness, is cited
as justification by Public Citizen as the basis for the removal
of Meridia from the market.
This request may be too late for many persons who have taken
Meridia based on physician advice and assertions of safety
from Abbott Laboratories. If you need assistance with a Meridia®-related
injury please
contact us. For further
information on Meridia use and side-effects please read below.
Who should consult a physician before Meridia® use?
-
Patients having suffered congestive heart failure or a stroke
- Patients having suffered seizures or a history of seizures
- Patients with coronary artery disease or arrhythmias
- Patients with anorexia nervosa
- Patients with glaucoma
- Patients with hypersensitivity or allergies to any Meridia
ingredients
- Patients with hypothyroidism or other 'natural' causes
of obesity
- Patients with increased blood pressure or at risk from
high blood pressure
- Patients taking other centrally acting appetite suppressant
drugs
- Patients taking monoamine oxidase inhibitors (MAOIs)
Potential symptoms of Meridia® use.
- Backaches and Headaches
- Flu-like symptoms
- Abdominal and stomach pain
- Chest and neck pain
- Dry mouth
- Anorexia
- Constipation
- Insomnia or the inability to sleep
Please note that these lists are not intended to be exhaustive. Research
may indicate the need to make note of additional symptoms
or use restrictions.
If you need assistance with a Meridia®-related injury please
contact
us.
1. Abbott Laboratories disputes
the validity of the concern by the FDA and maintains that the data relied on
is incorrect. It also claims that no patient deaths have been proven to
be the result of Meridia® use. However, Abbott Laboratories does admit
that there have been 34 deaths reported worldwide in patients using Meridia,
28 in the United States, 2 in Italy, 2 in Britain, 1 in South Africa and 1 in
Switzerland.
2. Publication date: May 14, 2002.
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