The FDA has been urged to ban Meridia by the consumer group, Public Citizen. The group maintains that the risks outweigh the benefits and calls it "unacceptably dangerous." The group states that there have been almost 400 serious adverse reactions reported to the FDA since Meridia was first marketed in 1998 through 2001. These serious reactions included 29 deaths and about 150 patients with arrhythmia and cardiovascular problems. Public Citizen states that "Meridia ... contributes to major cardiovascular problems" and has left patients with only higher risks of injury or death from using it."
"The effect of Meridia (sibutramine) in promoting weight loss is meager and it is not known if this drug, or any diet drug for that matter, can be taken safely for a long enough period of time to reduce the morbidity and mortality associated with obesity," wrote Dr. Sidney Wolfe and two of his colleagues on behalf of Public Citizen Health Research Group. They noted that the drug's use was recently suspended in Italy after two people died of health problems.

FDA spokeswoman Laura Bradbard said the agency regularly monitors "adverse events," including death, associated with drugs and will respond to the Public Citizen petition.

In 1997, before receiving FDA approval, an FDA advisory committee voted 5-4 that the benefits of Meridia did not outweigh its risks. Meridia was reviewed by an FDA medical officer who recommended that it not be approved because research showed the potential for cardiac complications. However, it was approved in 1997. The FDA estimates that approximately 20,000 Meridia prescriptions are filled in the United States each week. The FDA obtains reports of deaths and adverse reactions from voluntary submissions by physicians and hospitals. The number of actual adverse side effects and other incidents from prescription drugs is usually estimated to be tenfold higher than the number actually reported. The listing of a death in the FDA's files could mean that the drug will be investigated.

The FDA says 8 million people have taken the drug, Meridia (sibutramine) worldwide. Upon approving the drug in 1997, the FDA said it is "moderately effective" at helping patients lose weight. In studies, they lost about 7 to 11 more pounds than mere dieters.

The FDA also said that Meridia did not appear to pose the risk of heart valve damage that forced it to ban the popular diet drugs, Redux and fenfluramine, the "fen" in fen-phen. At the time, the FDA cautioned that "because of Meridia's side effects, no one with poorly controlled hypertension, heart disease or irregular heartbeat or who has survived a stroke should use the drug".

Abbott Laboratories, who acquired the drug called Meridia through its acquisition of Knoll Pharmaceuticals, has disputed the validity of the claims of Public Citizen and maintain that Meridia is safe when used as indicated. They also dispute the statistics kept by the FDA, claiming that "the patient deaths had not been proved to be caused by sibutramine (Meridia)".

If you or someone you know has taken Merida and have experienced dangerous side effects you may be entitled to compensation. Contact us for legal consultation

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