"…There is no evidence that this drug has prolonged the life of a single patient, or reduced the risks of strokes or heart attacks tied to obesity, …Instead, it has left patients with only higher risks of injury or death from using it, and high drug bills…"

Meridia works differently than other diet drugs in the past. Meridia is able to affect the chemistry of a patient's brain, regulating appetite by fooling the brain into thinking that the stomach is full, causing them to eat less.

Before the FDA approved Meridia for sale to the public, it was already concerned about the potential risks for patients taking the drug. In 1997, an FDA advisory committee held a vote on the safety of Meridia. They voted 5-4 that the benefits did not outweigh the risks. In fact, the FDA medical officer who reviewed the case recommended that the drug not be approved for public use because the benefits of the drug did not outweigh the risks. The concern of both the advisory committee and the FDA medical officer was based on evidence that Meridia significantly increases blood pressure and heart rate in many people.

In a study submitted to the FDA, people who took Meridia were three times more likely to experience significant ECG (electrocardiogram) changes than patient taking a placebo.

The central controversy surrounding this diet drug is one of risks verses benefit. The drug is marketed as a diet aide, a medication people can take to overcome obesity. Obesity presents many health problems; the most serious by far is the risk of death from heart disease. The problem with Meridia is that it can produce the exact symptoms that it was intended to help.

From the time it was introduced in February 1998 to Sept. 30, 2001, there were almost 400 serious adverse reactions in patients taking Meridia. This included 19 cardiac deaths, including 10 in people under the age of 50, three of whom were women under 30. The average yearly weight loss for patients taking a standard 10 mg dose was only six and a half pounds more than the loss in those taking a placebo.

Last month, the Italian government pulled Meridia, the brand name for sibutramine, from the market following two deaths associated with its use there. Other European governments also are reviewing the drug, including France and the United Kingdom, where there have been more than 100 serious adverse reactions and two deaths.