U.S. District Court Dismisses Claims Against Abbott Laboratories' Anti-Obesity Medication Meridia(R) (Sibutramine HCL Monohydrate) C-IV -- Court Finds No Scientific Evidence to Support Plaintiffs' Claim -- ABBOTT PARK, Ill., July 14 /PRNewswire-FirstCall/ -- The U.S. District Court for the Northern District of Ohio last week dismissed 113 cases against the company's anti-obesity medication, Meridia(R) (sibutramine HCl monohydrate) C-IV. The court found that the plaintiffs failed to come forward with sufficient scientific evidence to support the claims. "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." 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. 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 U.S. 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 percent 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. "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, M.D., professor of medicine and associate executive director of clinical research at Louisiana State University's Pennington Biomedical Research Center. "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." About Obesity Obesity is a serious disease and a major risk factor for the development of life-threatening illnesses such as coronary heart disease, hypertension, stroke, type 2 diabetes and certain types of cancer. In the United States, obesity can be attributed to 300,000 lost lives per year and has substantial economic consequences for the nation's health care system. In 2000, the total cost of health care for obesity was estimated at $117 billion. Meridia(R) (sibutramine HCI monohydrate) C-IV Use and Safety Information Meridia is available only by prescription. It is indicated for weight loss and maintenance of weight loss, and should be used in conjunction with a reduced-calorie diet. Meridia is recommended for obese patients with an initial body mass index (BMI) > 30 kg/m2 or > 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). Patients cannot take Meridia if they are taking prescription medicines called monoamine oxidase inhibitors (MAOIs). Meridia also cannot be taken if patients have anorexia nervosa or bulimia nervosa, are taking other weight loss medications that act on the brain or are allergic to any of the ingredients of Meridia. Meridia's label states that the drug substantially increases blood pressure in some patients. Patients being treated with Meridia should see their doctor as directed for regular monitoring of blood pressure and pulse rate. Meridia should be given with caution to those patients with history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension. Meridia should not be used in patients with a history of coronary artery disease, irregular heartbeats, congestive heart failure or stroke. Meridia should not be used in patients with severe liver or kidney disease. It should be used with caution in patients with narrow-angle glaucoma or a history of seizures. It is important that patients discuss with their doctor all current and past medical problems, all current symptoms, all medications that they take or have taken (prescription and over-the-counter medicines, including cough and cold medications, and herbal products) and any prior allergies to medicines. Patients should notify their doctor if they are taking medications that regulate the neurotransmitter serotonin in the brain: for example: Prozac(R) (fluoxetine), Zoloft(R) (sertraline), Effexor(R) (venlafaxine), Luvox(R) (fluvoxamine), Paxil(R) (paroxetine) or Zyban(R) (bupropion). Women who are pregnant or planning to become pregnant or who are breast-feeding their infant should not use Meridia. Patients need to talk to their doctors if they are taking medications that may increase their risk of bleeding (e.g. aspirin, clopidogrel, ticlopidine or Warfarin). Meridia is classified as a Schedule IV drug in the U.S., and its full prescribing information discloses it as such; patients who abuse Meridia may become dependent. The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. The brands listed are trademarks of their respective owners. For more information about Meridia (sibutramine HCl monohydrate) C-IV, including full prescribing information, please visit http://www.meridia.net/ . Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott Laboratories CONTACT: U.S. Media, Laureen Cassidy, +1-847-938-7743, or Media Outside the U.S., Sarah Henderson, +1-847-938-1170, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott Laboratories Web site: http://www.abbott.com/ http://www.meridia.net/ Company News On-Call: http://www.prnewswire.com/comp/121546.html

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