Bangkok--Mar 22--Siam PR Consultant
-- Obesity A Major Risk Factor for Premature Death--
ABBOTT PARK, Ill., March 21, 2002 - Abbott Laboratories wants to assure patients that it remains fully confident in the safety and effectiveness of sibutramine, Abbott's medication for the treatment of obesity. Sibutramine is sold under the name Meridia C-IV capsules in the U.S., and as Reductil in many markets around the world. Sibutramine was first approved in 1997 and has been used by more than 8.5 million people. The product is registered in more than 70 countries.
Patients who are obese are 60-70 percent more likely to die prematurely than patients who are moderately overweight. Obesity also places people at significantly greater risk for other medical conditions, such as diabetes, coronary artery disease, stroke, cancer, and respiratory diseases.
Obesity is the second leading cause of preventable death in the U.S., preceded only by smoking, and has been classified by the The World Health Organization as an epidemic.
Medication remains an important tool for physicians to treat this serious disease, as diet modification and exercise are often not sufficient.
The Abbott comment follows the Italian Ministry of Health's request that the European Committee for Proprietary Medicinal Products (CPMP) conduct a new risk/benefit analysis of sibutramine. The Italian Ministry cited reports of 50 adverse events, including two patient deaths, and temporarily suspended the marketing authorization.
Since the product was introduced in 1997, Abbott has continued to provide routine safety updates to regulatory authorities, in accordance with local regulatory requirements. Last week, Abbott provided a supplemental update to regulatory authorities with data on fatalities from the time of the product's approval in 1997 through March 10, 2002, in response to the concerns raised by the Italian Ministry. The update included 32 reports of patient fatalities throughout the five-year time period, during which more than 8.5 million patients used sibutramine.
"A careful analysis of the 32 fatalities does not point to an increased risk of death associated with the use of sibutramine," said Eugene Sun, M.D., vice president, global pharmaceutical development. "Many of these patients unfortunately had serious complications of obesity, which is associated with increased mortality."
Sibutramine should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension.
Product Information
Sibutramine is for use by prescription and should be used as part of a comprehensive weight management program that includes diet modification and exercise. Sibutramine should be used as indicated in its label should be used under the supervision of a physician. Sibutramine acts in the brain, where the body's signal for hunger occurs. It reduces food intake by increasing patients' satiety, or feeling of fullness. Sibutramine is not an appetite suppressant.
Patients cannot take sibutramine if they are taking prescription medicines called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. Sibutramine also cannot be taken if patients have anorexia nervosa, are taking other weight loss medications that act on the brain or are hypersensitive to any of the ingredients of sibutramine. Sibutramine substantially increases the blood pressure in some patients. Regular monitoring of blood pressure is required when taking sibutramine.
Sibutramine should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension. In clinical trials, the number of patients who discontinued sibutramine use because of hypertension was less than one-half of one percent and was comparable to placebo. As with all medications, sibutramine may not be for everyone. The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. As a centrally acting prescription anti-obesity medication, sibutramine is classified as a schedule IV drug in the U.S.
Sibutramine is indicated for people who need to lose 30 pounds (approximately 14 kg) or more depending on height, and should be used in conjunction with a reduced-calorie diet. Patients being treated with sibutramine should see their doctor as directed for regular follow-up visits, during which the doctor can carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate.
Through its acquisition of Knoll Pharmaceuticals and its sibutramine product, its strategic alliance with Millennium Pharmaceuticals to collaborate on the discovery and development of new drugs and diagnostics for metabolic diseases, and its traditional strengths in developing novel medical nutritional products, Abbott Laboratories is assembling the resources to develop innovative treatments for metabolic disorders, including obesity, hyperlipidemia and diabetes.
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries.
For Immediate Release
U.S. Media
Jennifer Smoter
(847) 935-8865
or
Melissa Brotz
(847) 935-3456
Media Outside the U.S.
Laureen Cassidy
(847) 938-7743
Investment Community
John Thomas
(847) 938-2655 End.
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