Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
MERIDIA® | SIBUTRAMINE
The U.S. Food and Drug Administration (FDA) and its European counterpart, the European Medicines Agency (EMEA), each announced that the agencies were reviewing sibutramine, which is sold in the United States under the brand name Meridia®, to investigate data from the SCOUT study (Sibutramine Cardiovascular Outcome Trial) suggesting a possible increased risk of serious cardiovascular events.
Recent data from the SCOUT trial suggests that patients taking sibutramine may have a higher risk of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients taking placebo. The FDA reported that the rate of cardiovascular events was 11.4% in the sibutramine arm versus 10% in the placebo arm. The FDA says that until its analysis is complete it is important for patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke avoid taking sibutramine.
Meridia® was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced-energy diet. Its chemical structure is similar to that of amphetamines. The weight loss drug is recommended for obese patients with an initial body mass index of at least 30 kg/m 2 or at least 27 kg/m 2 in the presence of other risk factors such as diabetes, dyslipidemia (high blood cholesterol and triglycerides) and controlled hypertension). Sibutramine is manufactured and sold by Abbott Laboratories under brand name Meridia®. It is classified as a Schedule IV controlled substance in the United State.
Prior to its approval, the FDA advisory committee reviewing the drug voted five to four that the benefits of sibutramine did not outweigh the risks. The FDA medical officer who reviewed the drug wrote that "[s]ibutramine has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval of the original submission." The concern of both the advisory committee and the FDA medical officer was based on the fact that sibutramine significantly increases blood pressure and heart rate in many people. Further, it was found that the average weight loss in people taking the drug for one year versus the average weight loss in people taking a placebo was only 6 1/2 pounds in the group taking 10 mg of the drug. Unfortunately, the drug obtained approval despite the advisory committee's findings.
Part of a post-approval commitment between the European Medicines Agency (EMEA) and the manufacturer, the study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. The study was initiated with 10,742 patients who had taken Meridia® for at least six weeks.
In December 2007, the preliminary findings of the SCOUT study were published which concluded that a six-week treatment with sibutramine appeared to be "efficacious, tolerable and safe." However, the authors of this study include not only investigators involved in the SCOUT study but also investigators who do studies and derive income from major pharmaceutical companies. The FDA and EMEA are now investigating the drug based on the latest findings of the study which appear to dispute the original conclusion that sibutramine is safe.
There have been previous concerns regarding the risks associated with the use of Meridia®. The drug is a serotonin and norepinephrine reuptake inhibitor. On May 5, 2009, the label for Meridia® was updated to include information warning about the development of potentially life-threatening serotonin syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions associated with Meridia® taken in conjunction with drugs known as triptans.
Symptoms of serotonin syndrome may include mental status changes (agitation, hallucinations, and coma), autonomic instability (tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (hyperreflexia and incoordination), and/or gastrointestinal tract symptoms (nausea, vomiting, and diarrhea). Severe cases can resemble NMS, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes.
In addition, the FDA issued an alert in 2008 after sibutramine was found in a variety of over-the-counter weight loss products. Users of the products were warned that health risks posed by the tainted products include high blood pressure, seizures, tachycardia, palpitations, heart attack, and stroke.
If you or someone you love were injured after taking Meridia® (sibutramine) for weight loss, you may be entitled to financial compensation. Please fill out our online form, or call us toll free at 1-888-839-3775 to discuss your rights with one of the experienced defective drug lawyers at our firm.
Evers & Preston, PL
609 West Chase Street
Pensacola, FL 32502-4711
Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
