News + Font Resize -

Abbott's anti-obesity medication Meridia gets relief from US district court
Abbott Park | Monday, July 19, 2004, 08:00 Hrs  [IST]

The US District Court for the Northern District of Ohio last week dismissed 113 cases against Abbott's anti-obesity medication, Meridia (sibutramine HCl monohydrate) C-IV. The court found that the plaintiffs failed to come forward with sufficient scientific evidence to support the claims, according to release from Abbott Laboratories.

"The court's decision supports what Abbott has long known, that Meridia, when combined with diet and exercise, has been approved as a safe and effective option for the treatment of obesity," said William G Dempsey, senior vice president of Pharmaceutical Operations and president of Pharmaceutical Products Division. "We hope that this court decision brings to a stop the alarming and medically inaccurate campaign of fear, confusion and misinformation perpetuated by the plaintiffs' attorneys and certain consumer watchdog groups," he added.

Meridia scientific data is sound in its decision, the court held that the plaintiffs lacked sufficient and reliable evidence to support their claims, and concluded that an expert for the plaintiffs lacked appropriate qualifications to address cardiovascular events. Likewise, the court dismissed as "irrelevant" certain data produced by another expert for the plaintiffs. Also, though not mandatory in cases of this nature, the court noted that plaintiffs lacked epidemiological evidence to support the claims, the release says.

Meridia has been approved as a safe and effective treatment for obesity when combined with diet and exercise, and has been extensively studied in more than 100 clinical trials involving more than 12,000 patients throughout the world. Approximately 13 million patients in more than 70 countries have used sibutramine for the treatment of obesity. Meridia has been approved in the US since 1997.

Meridia is an important option for appropriate patients with obesity who, without assistance of pharmacotherapy, are unable to manage their obesity through diet and exercise alone. In studies, sibutramine, in combination with diet and exercise, was effective in producing and maintaining statistically significant weight loss in the majority of obese patients compared to diet and exercise alone. In a two-year trial, nearly three times as many patients on Meridia in combination with diet and exercise maintained at least 80 per cent of their initial six-month weight loss when compared to patients practicing diet and exercise alone. Research has shown that maintaining a weight loss of five to ten percent of body weight significantly reduces the risk of obesity-related adverse health conditions, the release continues.

"Obesity is a serious disease that threatens the health and well-being of a rapidly growing percentage of the population in countries around the world," said Donna H Ryan, professor of medicine and associate executive director of clinical research at Louisiana State University's Pennington Biomedical Research Centre. He added, "Meridia is one of the few effective medical treatments we have when diet and exercise alone are not enough. It may not work for everyone, but it has helped, and continues to help, numerous individuals lose weight."

Post Your Comment

 

Enquiry Form