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| |  Reductil Approved In Germany For Management Of Obesity MOUNT OLIVE, NJ -- Jan. 18, 1999 -- BASF Pharma’s Reductil(R) (sibutramine hydrochloride monohydrate) has been granted marketing authorisation by the Germany regulatory agency for the management of obesity. The drug is marketed as Meridia(R) C-IV Capsules in the United States by Knoll Pharmaceutical Co., the U.S. pharmaceutical subsidiary of BASF Pharma. In the U.S., Meridia is indicated for the management of obesity, including weight loss and maintenance of weight loss when used in conjunction with a reduced-calorie diet and increased physical activity. Meridia is recommended for patients with an initial BMI greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) in the presence of other risk factors (for example, hypertension, diabetes). Meridia/Reductil has been shown to be effective and well tolerated in clinical trials involving over 6,000 patients. The safety and effectiveness of the product, as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond one year at this time. Obesity is a complex, chronic disease caused by genetic and environmental factors that may vary by culture, including an abundance of high-calorie foods, ever-expanding portion sizes and a clean your plate mentality. Feeling satisfied with less food is a major barrier to weight loss. For some people, medication may be necessary to help them gain control over their appetite. Meridia/Reductil may help these people beginning a weight-loss program feel full, so they can eat less. Most side effects with the drug are mild and temporary and include dry mouth, headache, insomnia and constipation. Some people taking the drug experienced substantial increases in blood pressure and for this reason regular blood pressure monitoring is required when taking it. These blood pressure increases generally occur early in treatment and the prescribing physician may decide to decrease the dose of Meridia or discontinue the medication. In clinical trials, the number of patients who discontinued Meridia use because of hypertension was less than one-half of one percent and was comparable to placebo. Meridia 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. As a centrally-acting prescription anti-obesity drug, Meridia is classified as a schedule IV drug.
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