Meridia Personal Injury

MERIDIA (sibutramine hydrochloride monohydrate), Abbott Laboratories (website), 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in the deaths of 29 users in 3 years from apparent cardiac complications, Abbott Laboratories has not voluntarily withdrawn Meridia from the market.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 . . . (letter here)

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)

Testimony: Yesterday, we asked for criminal prosecution of Abbott, based on an FDA inspection of the company in the last few weeks in which there was some manipulation of information on eight deaths that occurred with Meridia. There must be a major effort to prevent risk management from becoming a device to rescue and salvage drugs that should be withdrawn.  Recent examples include Lotronex, Meridia, Posicor, Rezulin, Duract and so forth.