Weight Loss Drug Meridia Comes Under Fire…Again
Effective and safe weight loss pills may be considered the holy grail of the pharmaceutical industry. It has been difficult to even get such a drug through the rigorous trials required by the Food and Drug Administration (FDA), and even then most are shot down due to side effects being above and beyond what it considered acceptable. Most recently, the FDA shot down the promising Qnexa in July citing concerns over side effects.
One weight loss drug that remains on the market is Meridia by Abbott Laboratories, however repeated studies have shown that the side effects can be more lethal than keeping the excess weight. Data from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study showed increased cardiovascular events in patients who took Meridia (sibutramine). Consequently, Abbott Laboratories agreed to add new contraindications on materials for the drug, specifically for patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension.
While Abbott Laboratories has complied with the FDA on labeling, the executive editor of the New England Journal of Medicine is keeping the fight alive to pull the drug off the market, citing that the modest benefits do not outweigh the risks. In an editorial that accompanies the full report on the study of sibutramine, Dr. Gregory D. Curfman believes that “Sibutramine doesn’t help people. It doesn’t result in very much weight loss, and it doesn’t improve their clinical condition. On the other side, it carries these risks.”
The U.S. Food and Drug Administration will be holding hearings next week to reconsider the Meridia’s safety. Meanwhile, the only other weight loss drug currently FDA approved for long term use is Xenical. There are still two weight loss drugs awaiting FDA approval: Contrave by Orexigen Therapeutics Inc. is scheduled for the committee in December of this year, while Lorcaserin from Arena Pharmaceuticals Inc is set for committee on September 16th. Contrave has a similar formulation to Qnexa (the drug rejected in July), utilizing both an anticonvulsant and an amphetamine but in different dosages. Lorcaserin is completely different, and with less side effects than the anticonvulsant/amphetamine mixture.










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