MERIDIA

The suspect diet pill is Meridia, made by Abbott Laboratories. It is used by some 9 million people worldwide since it went on the market in early 1998. It had been approved by the FDA the previous year despite studies that showed the drug slightly increased the blood pressure and heart rate of some patients and substantially increased them in others. The FDA’s medical officer who reviewed the drug concluded that it “has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval of the original submission.” The agency’s advisory committee voted five-to-four against its approval. The FDA approved it anyway, in November 1997.

How it Works

Meridia’s generic name is sibutramine. Like both the anti-depressant Serzone and the diet drug, fenfluramine (remember the fen-phen combination recalled in 1997 for causing heart valve damage?) Meridia affects the body’s use of serotonin. However, whereas fen-phen boosted production of serotonin to fool the brain into making patients feel their bellies were full, Meridia uses the opposite approach , slowing the body’s absorption of the brain’s natural serotonin output to achieve the same self-deception.

Death by Diet Pill

Since February 1998, when it went on to the market, Meridia has been linked with:

• 34 deaths worldwide, 29 in the United States, 19 of them from heart attacks or other cardiovascular causes;
• 10 cardiac death of persons 50 years old or younger, including three women under 30
• 397 serious adverse reactions reported to the FDA, including
• 152 patients whose reactions were severe enough to require hospitalization, and
• 143 patients in whom arrhythmia (an abnormal heartbeat) was reported.
Abbott Laboratories disputed the validity of the numbers, arguing that it hasn’t yet been proven that the diet pill caused the effects. Numbers aside, the adverse reactions to Meridia that have been reported to FDA include such serious concerns as:
• Stroke
• Heart attacks and other cardiovascular injuries
• Arrhythmia
• Blood clots near the eyes
• Increased blood pressure and heart rate
• Body aches; neck and chest spasms
• Nervousness, hyperactivity, and anxiety

Meridia’s effectiveness as a weight-loss aid is also being questioned. In approving the drug the FDA reported that in clinical trials, obese people taking Meridia for one year could expect to lose an average of only 6.5 pounds compared to those taking a placebo. The risk-benefit ratio question is losing 6.5 pounds worth the heightened risk of a fatal heart attack?