MERIDIA (sibutramine hydrochloride monohydrate), Abbott
Laboratories,
is an orally administered agent for the treatment of obesity. Each
MERIDIA capsule contains sibutramine hydrochloride monohydrate.
Sibutramine produces its therapeutic effects by norepinephrine,
serotonin and dopamine reuptake inhibition.
Although Meridia has been implicated in the deaths of 29 users
in 3 years from apparent cardiac complications, Abbott Laboratories
has not voluntarily withdrawn Meridia from the market. Abbott
Labs refutes these death claims.
Voluntary reports of adverse events temporally associated with
the use of Meridia are listed below. It is important to emphasize
that although these events occurred during treatment with Meridia,
they may have no causal relationship with the drug. Obesity itself,
concurrent disease states/risk factors, or weight reduction may
be associated with increased risk for some of these events.
Body as a Whole: anaphylactic shock, anaphylactoid reaction, facial
edema, fluid retention, lack of drug effect.
Cardiovascular: angina pectoris, abnormal ECG, arrhythmia, atrial
fibrillation, cerebrovascular accident, chest pressure, chest tightness,
congestive heart failure, heart arrest, heart rate decreased, hemorrhage,
myocardial infarction, sudden unexplained death, supraventricular
tachycardia, syncope, torsade de pointes, transient ischemic attack,
ventricular extrasystoles, ventricular fibrillation, ventricular
tachycardia.
Digestive: abnormal stools, cholecystitis, cholelithiasis, duodenal
ulcer, eructation, gastrointestinal hemorrhage, increased salivation,
intestinal obstruction, mouth ulcer, stomach ulcer, tongue edema.
Endocrine: goiter, hyperthyroidism, hypothyroidism.
Hemic and Lymphatic: anemia, leukopenia, lymphadenopathy, petechiae,
thrombocytopenia.
Metabolic and Nutritional: hyperglycemia, hypoglycemia. Musculoskeletal:
arthrosis, bursitis.
Nervous: abnormal dreams, abnormal gait, amnesia, anger, concentration
impaired, confusion, depression aggravated, Gilles de la Tourette's
syndrome, hypesthesia, libido decreased, libido increased, manic
reaction, mood changes, nightmares, serotonin syndrome, short term
memory loss, speech disorder, tremor, twitch, vascular headache,
vertigo. Respiratory: epistaxis, nasal congestion, respiratory
disorder, yawn.
Skin and Appendages: alopecia, dermatitis, limb pain, photosensitivity,
urticaria. Special Senses: abnormal vision, blurred vision, dry
eye, eye pain, increased intraocular pressure, otitis externa,
otitis media, photosensitivity, tinnitus.
Urogenital: abnormal ejaculation, hematuria, impotence, increased
urinary frequency, micturition difficulty.
Meridia Links
Meridia Product Information (Abbott Laboratories)
Letter to FDA Requesting ban of Meridia written by Public Citizen:
Public Citizen, a nationwide consumer organization petitions the
FDA to immediately ban the unacceptably dangerous prescription
diet drug Meridia (sibutramine, Knoll Pharmaceuticals/Abbott).
According to the FDA data base, since its launch in early 1998
sibutramine has now been associated with 29 deaths including 19
from cardiovascular adverse effects in people using this minimally
effective drug. Two weeks ago, its use was suspended in Italy because
of two cardiovascular deaths and its safety is currently under
review in other European countries where, in the UK and France
alone, there have been a total of 103 serious adverse reaction
reports in people using the drug including two deaths in Britain.
Prior to its approval in 1997, a FDA advisory committee voted five
to four . . . (pdf
document)
A letter to Department of Health and Human Services urging them
to bring criminal charges against Abbott Laboratories for illegally
withholding from the FDA important information concerning eight
deaths and other adverse effects of their big-selling obesity drug,
sibutramine (Meridia) (letter
here)
Interesting letter from Abbot Labs to FDA responding "furthermore,
Abbott is confident that all confirmed fatalities reported to the
company coincident with Meridia use (more)
More Class Action Lawsuit Information:
Each year in Texas, and throughout the United States, millions
of people are injured through the negligence of companies that
release unsafe or defective products. If you have used or been
exposed to any of these products, we can help. There are statutes
of limitations involved in Texas class actions, so contact us as
soon as possible to protect your rights!
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in Texas, the United States District Courts in the Northern and
Eastern Districts of Texas and the Fifth United States Circuit
Court of Appeals.
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