Based on pressure from the Food and Drug Administration (FDA), Abbott Laboratories, manufacturer of Meridia (sibutramine), has decided to recall the drug in the United States, Canada, and Australia effective immediately.
A study published in the New England Journal of Medicine last month established that the long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. According to the study, "10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both, were enrolled to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events." Results stated that Meridia increases the risk of heart attack and stroke by 11%, while doing little to assist with weight loss. The study also tied Meridia to 16 percent more major cardiovascular side effects. The FDA has linked 17 deaths to Meridia thus far, with 70% being women with an average age of 43.
Global sales of the drug in the first nine months of this year were $80 million, including $20 million in the U.S.
According to Forbes, the FDA also announced today that it found sibutramine in a "100% herbal" dietary supplement called Slimming Beauty, sold by Beautiful Health, Inc. The supplement was distributed at the 40th Annual Mexican Independence Day Parade in Chicago, on Sept. 12, 2010 and caused reports of insomnia, vomiting, and spiking blood pressure.
An FDA advisory panel voted to decide whether to keep the diet drug Merdia on the market following reports and studies linking the drug to cardiovascular problems, including heart attack and stroke. The FDA panel vote was split - eight members called for withdrawal, six for restricted sales and a "black box" warning, and two for the warning plus close monitoring of patients. The FDA's own monitoring linked 14 deaths to the use of Meridia. Patients who died were 43 years old, on average, and 71% were women.
Following a November 2010 clinical trial paid for by its manufacturer, Abbott Laboratories, the popular diet drug Meridia (Sibutramine), has come under a great deal of scrutiny by the Food and Drug Administration (FDA). Meridia, which was first approved by the FDA in 1997, has been found to increase the risk of heart attack and stroke by 11%, while doing little to assist with weight loss. According to the New York Times, three of the authors of the study whom are Abbott employees concluded that the trial results did little more than show that patients with heart problems should not be prescribed Meridia-a restriction already included in Meridia's label.
In an additional study on Meridia published in the New England Journal of Medicine in September 2010, the risk of a stroke, heart attack, cardiac arrest or cardiac death was 16% higher among people taking Meridia, compared with those taking a placebo. All of the 9,804 overweight or obese study participants had a history of cardiovascular disease.
New England Journal of Medicine's editor, Dr. Gregory D. Curfman wrote an editorial following the trial's initial analysis, stating that the study proved that Meridia should be removed from the market. Regardless, Abbott Laboratories maintains that "the risks of Meridia are outweighed by its benefits and that new data on its cardiovascular safety doesn't change the fact that it's safe for patients when used strictly according to its label."
With added pressure to remain thin, many men and women resort to diet drugs which promise a lean figure. While some dietary supplements have proved to be safe and effective, the majority tend to cause a great deal of dangerous side effects such as high blood pressure, heart attack, and stroke.
Meridia is a weight control pill made by Abbot Laboratories. Also known as sibutamine, Reductil, and Reduxade, Meridia is a neurotransmitter reuptake inhibitor that regulates appetite by affecting natural chemicals in the brain.
Meridia has been associated with many side effects and various consumer groups have asked the U.S. Food and Drug Administration (FDA) to ban further sale of the diet drug. Abbott has disclosed 34 deaths of Meridia patients but states it sees no pattern to the deaths or connection to Meridia. 16 deaths resulted from cardiovascular problems. The Italian government banned Meridia following deaths attributed to the diet drug. Some medical professionals are now advising patients to immediately discontinue Meridia use and the FDA is “looking into the adverse events of Meridia.”
Numerous side effects are associated with Meridia, including: abdominal pain, indigestion, anxiety, back pain, constipation, coughing, dizziness, headaches, dry mouth, flu symptoms/bronchitis, insomnia, joint pain, loss of strength, nausea, painful menstruation, rash, sore throat, shortness of breath, cramps, kidney problems, heart problems, seizures, and other side effects.
The FDA issued a warning letter to Abbot in August 2002, after the manufacturer failed to report the death of a user of its diet drug Meridia and inaccurately reported other serious reactions among users of three other medicines. The consumer protection group Public Citizen has urged the FDA to ban Meridia and has accused Abbot of intentionally and illegally concealing important risk information regarding the drug.
Additional Information from the FDA: