Reductil Approved In Switzerland And South Africa For Obesity
Management
TORONTO, ON -- Feb. 22, 1999
--
Knoll Pharma’s Reductil(R) (sibutramine
hydrochloride monohydrate) has been approved in Switzerland and South Africa for
the management of obesity.
The drug is known as Meridia(R) in North America.
Reductil is intended for the management of obesity, including weight loss and maintenance of weight loss, when used in conjunction with a reduced calorie diet. It is a neurotransmitter reuptake inhibitor -- it works by maintaining the brain's natural level of serotonin and norepinephrine, which regulate appetite. By allowing the serotonin and norepinephrine to act longer, Reductil brings on the feeling of fullness faster so that the individual consequently eats less.
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 Reductil or discontinue the medication. In clinical trials, the number of patients who discontinued Reductil use because of hypertension was less than one-half of one percent and was comparable to placebo.
Reductil 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, Reductil is classified as a schedule IV drug.
