Meridia Information
Meridia is an appetite suppressant. It does not contain Phentermine.
It is an oral prescription medication used for the medical management of obesity, including weight loss and the maintenance of weight loss and should be used in conjunction with a reduced calorie diet.
Meridia can only be prescribed by a medical doctor. It comes in three different strength capsules (5 mg, 10 mg, and 15 mg). The recommended initial starting dose is one 10 mg capsule per day. Your doctor will determine the starting dose that is best for you.
To be effective, it must be used along with a sensible eating plan, behavior modification, and a regular exercise program.
To maintain weight loss or to continue to lose additional weight after stopping sibutramine, it is necessary to follow a sensible eating plan and an exercise program.
Since it was first approved in 1997, more than 8.5 million people in more than 70 countries have used Meridia for the management of obesity.
This page provides information on the following topics:
Indication and Safety ProfileCurrent Safety Topics in the News Benefits of Losing WeightHow MERIDIA Works
Indication and Safety Profile
Meridia is indicated for people who need to lose 30 pounds or more depending on height, and should be used in conjunction with a reduced-calorie diet. Patients being treated with MERIDIA 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.
It is available only by prescription and should be used as part of a comprehensive weight management program. MERIDIA should be used according to its label and under the supervision of a physician. Many people have found weight-loss success with Meridia. But it’s not for everyone.
Patients cannot take MERIDIA if they are taking prescription medicines called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. It 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 in it.
Meridia should not be used in patients with a history of coronary artery disease, arrhythmias, congestive heart failure, or stroke. It substantially increases blood pressure in some patients. Regular monitoring of blood pressure is required when taking MERIDIA. It 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 use because of hypertension was less than ½ of 1 percent and was comparable to placebo.
The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. It is a controlled substance, which means that abuse may lead to dependency.
Current Safety Topics in the News
You may have heard Meridia mentioned in the news recently. Abbott Laboratories would like to assure you of the safety, effectiveness and continued availability of MERIDIA in the United States.
In early March 2002, the Ministry of Health in Italy temporarily suspended sales of Reductil® (sibutramine, brand available in Italy) based on 2 reports of death in Italy. Abbott Laboratories’ thorough review of these reports indicated that both patients had other complicating conditions and had been taking other medications. While any death is a tragedy, there is no established link between the cause of these deaths and Meridia . Based on Abbott’s worldwide safety analysis and
clinical trial experience of Meridia , the evidence does not point to an increased risk of death in patients taking Meridia .
In June 2002, after completing a comprehensive assessment of sibutramine, Europe’s Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion reaffirming the favorable risk/benefit profile of sibutramine. The positive opinion was supported by an extensive analysis of data that included more than 100 clinical trials involving more than 12,000 obese patients. We are fully confident in the safety and effectiveness of Meridia .
Since it was first approved in 1997, more than 8.5 million people in more than 70 countries have used MERIDIA for the management of obesity. Meridia is the most extensively studied prescription medication for obesity and was determined to be safe and effective by the FDA.
For Abbott’s response to the Public Citizen’s petition submitted March 19, 2002, to the FDA regarding MERIDIA click here.
Benefits of Losing Weight with MERIDIA
Clinical studies have clearly demonstrated that sibutramine, in combination with diet and exercise, has demonstrated three clinical benefits in weight management:
1) enhancing weight loss,
2) improving weight maintenance, and
3) impacting certain clinical measures associated with obesity.
Meridia Study
The Sibutramine Trial of Obesity Reduction and Maintenance – the S.T.O.R.M. Trial – is a two-year study that looked at weight loss and weight maintenance in patients using sibutramine, with diet and exercise, compared to patients on diet and exercise alone. This study, published in the Lancet, a leading international medical journal, demonstrated that sibutramine, in combination with diet and exercise, was significantly more effective than diet and exercise alone in maintaining weight loss over 2
years. Additional analyses of this study demonstrated that weight loss in the sibutramine treatment group was also associated with significant improvements in HDL-cholesterol and triglyceride levels.
In this study, 94 percent of patients treated with sibutramine and a diet and exercise program for the first 6 months lost greater than 5 percent of their body weight and approximately 55 percent lost at least 10 percent of their initial body weight. After 6 months, patients were divided into 2 groups: sibutramine with diet and exercise, and diet and exercise alone for an additional 18 months. Nearly 70 percent of patients taking sibutramine maintained a 5 percent weight loss at 2 years, compared to 42 percent of patients on diet and
exercise alone. A 10-percent loss was maintained by 46 percent of the people receiving sibutramine, while only 20 percent of the patients on diet and exercise alone saw a similar result at 2 years. Forty-three percent of patients maintained at least 80% of their weight loss at 2 years compared with only 16% of those in the diet and exercise alone group.
Currently, there are only 2 pharmacologic options indicated for long-term (up to 2 years) weight management, one of which is Meridia , that have been approved by both the FDA and the European regulatory agencies.
Meridia has been studied extensively and thoroughly in more than 100 clinical studies, which included more than 12,000 patients. Since Meridia was first approved in 1997, more than 8.5 million people in more than 70 countries have used it for the management of obesity.
Other Meridia Trials
Researchers at Nova Southeastern University in Ft. Lauderdale, Florida, conducted a double-blind, controlled study and found Meridia (sibutramine) to be effective in reducing weight when it is used along with a reduced-calorie diet, behavior modification, and an exercise program. They also warned that some patients experience a substantial increase in heart rate and blood pressure.
The manufacturer reports that weight loss was examined in eleven double-blind, placebo-controlled obesity trials that lasted from 12 to 52 weeks and used doses ranging from 1 to 30 mg 1 time daily. Compared with patients who took placebos, those who took 5 to 20 mg of sibutramine daily lost significantly more weight. Analysis of data from three studies that lasted 6 months or longer indicates that patients who lose at least 4 pounds during the first 4 weeks of treatment on a given dose will most likely achieve significant long-term weight
loss on that same dose.
Studies show that people who follow a low-calorie diet and take it for 6 to 12 months lose about 11 lbs, while people who follow the same low-calorie diet but do not take Meridia lose only about 2.2 lbs.
Approximately 50% to 60% of the people who take Meridia lose more than 5% to 10% of their body weight while taking the medication, compared with about 20% to 30% of people who follow the low-calorie diet only.
However, it doesn't work for everyone. Studies show that about 10% of people do not lose weight while taking Meridia. If you have not lost about 4 lb within the first month of treatment, it may not be an effective medication for you.
How it Works
Meridia works by affecting appetite control centers in the brain. It reduces food intake by increasing satiety, or feeling of fullness. It is not an appetite suppressant.
Manufacturer
Knoll Pharmaceutical Company
Corporate Headquarters
3000 Continental Drive
North Mount Olive, NJ 07828-1234
USA Meridia is a trademark of Knoll Pharmaceuticals, now Abbott Laboratories |
