Sibutramine danger, safety, caution, side effects, abuse, effect on heart, adverse events  Meridia product name Ray Sahelian, M.D.
Feb 5 2014

 

Sibutramine hydrochloride is a weight loss drug used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. it is thought to work by increasing the activity of certain chemicals, called norepinephrine and serotonin, in the brain. This medicine is approved for use only in people who are very overweight. Sibutramine is a monoamine-reuptake inhibitor.

 

2010 - Abbott Laboratories agreed to pull its 13-year-old diet pill Meridia off the U.S. market because of heart attack and stroke risks.


Sibutramine side effects, safety, danger, risk

Sibutramine is used for weight reduction, but has been linked to side effects such as increasing heart rate and blood pressure, headaches, constipation, dizziness and insomnia. It increases the rate of heart disease.

   Common sibutramine side effects are: anxiety; constipation; dizziness; dryness of mouth; headache; irritability or unusual impatience ; nervousness; stuffy or runny nose; trouble sleeping. Potentially serious sibutramine side effects are: fast or irregular heartbeat; increased blood pressure ; mental depression; painful menstruation; swelling of body or of feet and ankles. Additional sibutramine side effects may occur if it is combined with other medicines.

 

Patients taking Abbott Laboratories Inc's weight loss drug Meridia have a higher risk of cardiovascular problems. The FDA said in November 2009 that early findings from a study suggested patients taking Meridia, also known as sibutramine, may have a higher number of cardiovascular-related problems, including heart attacks, strokes, cardiac arrests and deaths, when compared to patients who took a placebo. The FDA in 2005 rejected a consumer group's petition to remove Meridia from the market due to cardiovascular problems, deciding that the drug's benefits outweighed its risks when used appropriately to treat obesity. The FDA said at that time that it was not possible to conclude sibutramine caused the reported problems and that it had worked with Abbott to change the drug's labeling and to educate doctors about which patients can take the drug.

 

A study funded by Abbott Laboratories offered more detailed evidence that its weight-loss drug Meridia increases heart risks, prompting renewed calls by consumer advocates and others to pull the drug from the market. New England Journal of Medicine, online September 2, 2010.

 

U.S. health regulators could pull the controversial weight-loss drug Meridia (from Abbott Laboratories) off the market over heart problems. In memos released ahead of a public meeting to discuss the diet pill in September 2010, Food and Drug Administration officials said they planned to ask outside advisers whether to ban Meridia, take other regulatory action, or leave the prescription drug as is.

 

Ned Tijdschr Geneeskd. 2013. Life-threatening psychosis caused by using sibutramine-contaminated weight-loss coffee.
 

Sibutramine and thermogenesis
Effects of sibutramine on thermogenesis in obese patients assessed via immersion calorimetry.
Adv Ther. 2006 Nov-Dec;23(6):1016-29. Department of Endocrinology and Metabolism, Ege University Medical School, Izmir, Turkey.
Glucose utilization studies show that sibutramine induced thermogenesis is mediated via selective sympathetic activation of brown adipose tissue. The goal of the present study was to use a new calorimetry method in which resting metabolic rate is enhanced to evaluate the effects of sibutramine treatment on thermogenesis. Sixty obese women were included in the study. Subjects were divided into 2 equal groups-the placebo and sibutramine treatment groups. The sibutramine group was given sibutramine 10 mg daily for 12 wk. At baseline and at the end of the 12-wk treatment period, thermogenic measurements were taken with the use of water immersion calorimetry. The findings of this study suggest that sibutramine treatment promotes thermogenesis, thus facilitating weight loss.

 

Sibutramine for Teenagers and adolescents

Effects of sibutramine treatment in obese adolescents: a randomized trial.
Ann Intern Med. 2006. The Behavioral Health Center, The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy. To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program. DESIGN: 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002. 498 participants 12 to 16 years of age with a body mass index (BMI) that was at least 2 units more than the U.S. weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2. Interventions: Site-specific behavior therapy plus 10 mg of sibutramine or placebo. Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%. The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the sibutramine and placebo groups, respectively, did not complete follow-up. Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.
 

Obese adolescents who are put on a low-calorie diet and exercise program do not seem to derive any additional benefit from taking the diet drug sibutramine, sold in the United States under the trade name Meridia, according to a Dutch study.

In adults, sibutramine reduces calorie intake by increasing the feeling of fullness and increasing the metabolic rate, so more calories are burned. But it is unclear if the drug has the same effects on obese adolescents.
Dr. Edgar G. A. H. Van Mil, of the VU University Medical Center, Amsterdam, conducted a study with 24 obese teens who were randomly assigned to sibutramine or a placebo. Both groups also where given a low-calorie diet and physical exercise program to follow. After 12 weeks, the teens stayed on their diet and exercise program, but stopped taking the sibutramine drug. The weight of the patients was comparable in both groups after the 12-week trial,. However, the weight loss concluded after the placebo was discontinued, whereas weight loss only stabilized in teens who discontinued sibutramine. The team also measured the subjects' body composition and metabolic rate using underwater weighing and special X-ray imaging techniques. The changes in the percentage of fat mass were not different between the sibutramine and placebo groups and there were no significant changes in metabolism, the investigators found. The researchers then measured basal metabolic rate, the amount of calories the body burns while at rest. They found that it initially decreased in the placebo group and remained constant in the sibutramine group. However, during the follow-up period, the basal metabolic rate increased in the placebo group and decreased in the sibutramine group. In this study, it did not appear that sibutramine had a major effect. Journal of Clinical Endocrinology and Metabolism, April 2007.