According to Lindsay Kloer and Sue Nyberg of Wichita State University, only two long-term weight-loss drugs earned Food and Drug Administration approval for prescription use during 2007. These two drugs were sibutramine (Reductil and Meridia) and orlistat (Xenical). However, in April of 2009, the FDA disclosed to the public that many over-the-counter supplements contained sibutramine as well as other undisclosed prescription only drugs. That's a violation of the FDA's authority and a safety risk to individuals who use them (see link in Resources Section for product list).
Sibutramine (Reductil and Meridia): How it Works
Through manipulation of neurotransmitters in the brain (noradrenalin and serotonin), sibutramine suppresses appetite. When noradrenalin and serotonin (chemicals that exist in nerve cells) are released from the nerve cell for purposes of communication with other cells, they are then reabsorbed back into the nerve cell again. However, sibutramine prevents that reabsorption, leaving these two chemicals to roam about the brain freely, causing decrease in appetite as one consequence of their free movement.
Sibutramine and Obesity Treatment
Given the effect sibutramine has on decreasing appetite, it became a drug of choice for treatment of severe obesity. The drug's use, however, is now only allowed for use by individuals who qualify as being severely obese.
Reductile and Meridia Sibutramine History
Approved by the FDA on Nov. 22, 1997, sibutramine has been held accountable for deaths and other adverse reactions, according to a nationwide consumer organization called Public Citizen. This group, utilizing reported data made available to them due to the Freedom of Information Act (FOIA), sought a ban on sibutramine in 2002.
Sibutramine and Adverse Reaction Records
In a letter to the FDA dated March 19, 2002, Public Citizen sought a ban on sibutramine. The group stated that, according to information made available by the FOIA, sibutramine use was responsible for 29 deaths. Of those, 19 were cardiovascular-related among several in people under the age of 30; 10 others were less than 50 years old. The group cited 397 other adverse reactions.
Incidentally, the letter was sent on the heels of a Reuters news report on March 15, 2002, which alluded to a relationship between two deaths in Britain and use of sibutramine.
FDA Prohibits Sibutramine in Supplements
As mentioned earlier in this article, sibutramine (Reductile and Meridia) is not supposed to be available in over-the-counter products or supplements, especially in light of the recognized danger it can present to individuals by raising their blood pressure and heart rates (see link in Resources Section below to the FDA Medical Officer's review comments about sibutramine, as well as the FDA's stated warnings in the April 2009 public disclosure).
Given the concern of watchdog groups about this drug, even in formally prescribed and monitored medical conditions, it is important that consumers be aware of its dangers and possible use in supplements coming from questionable manufacturers.
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