Following the recall of weight loss drugs fenfluramine (one of the halves of the fen-phen drug mix) and Redux from the market in 1997 due to links with life threatening heart valve abnormalities, the Federal Drug Administration approved Meridia (sibutramine HCI monohydrate) as a treatment for people who are obese/overweight and have no previous history of cardiovascular disease (heart conditions).
How Meridia Works
Meridia inhibits the reabsorption of serotonin, a chemical released into the brain that makes people feel full after they have eaten. This blocking of reuptake gives people a feeling of fullness for longer periods and is thought to reduce the daily caloric consumption because the appetite will be suppressed.
Testing showed that those who took Meridia and went on a reduced calorie diet as well as incorporating lifestyle changes, experienced a 5 to 10 percent weight reduction. In a twelve month study patients who took 10 mg. of Meridia per day lost an average of 10 pounds while patients who took 15 mg. of Meridia per day lost an average of 14 pounds.
The conclusion was that Meridian was a sufficient drug for weight loss although dangerous side effects such as an increase in blood pressure or heart rate were possible as well as arrhythmias.
Meridia Taken Off the Market
Meridia has since been taken off the market in the United States.
By October of 2010, Meridia was no longer available for purchase in the United States. At the request of the Federal Drug Administration (FDA), Abbott Laboratories withdrew the drug from the marketplace although they statd that they strongly disagreed with the FDA's contentions.
The initial concerns about the drug's adverse side effects were relaxed because it was believed that the benefits of Meridia effectively countered the risks. But a large study showed that people who took the drug had an 11% chance for cardiovascular problems. Although the drug was not supposed be used on patients who had cardiovascular disease, a conflict presented revolving around the possibility of people being prescribed Meridia who had an undiagnosed cardiovascular disease.
The FDA concluded that the modest weight loss afforded by Meridia did not justify the risks associated with the drug although many members of the advisory committee endorsed keeping it on the market but with new warnings and strict regulations as to who could prescribe it.
FDA monitoring also linked 14 deaths to the use of Meridia. The average age of death was 43 years old, and 71% of those who died were females.
Unapproved drugs that are sold as supplements have been found to contain sibutramine, the active ingredient in Meridia.
Meridia is currently under a patent that prevents the manufacture of any generic versions in the United States, although the Internet is ripe with offers for "generic Meridia."
These medications can be fake, substandard, and potentially dangerous and should be avoided. Generic versions might be available from other countries but the same concerns apply. Until there is an approval, buying generic Meridia is not recommended.
Due to patent rights, a generic version of Meridia will not be available until 2013. Until that time, you should ask your doctor about appropriate weight loss treamtents.
eMedTV - http://weight-loss.emedtv.com/meridia/generic-meridia.html-
WebMD - http://www.webmd.com/diet/news/20101008/fda-rejects-weight-loss-drug-meridia
- accessed 8/20/12
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