The FDA approved Meridia in November 1997 for weight loss and maintenance of weight loss in obese people, and in overweight people with other risks for heart disease.
The agency's approval was based on studies showing that about twice as many people taking Meridia lost at least 5 percent of their body weight compared with people taking a placebo who used diet and exercise alone to lose weight, Jenkins said.
Jenkins said that, when the drug was approved, the FDA did have safety concerns because Meridia was known to increase both blood pressure and heart rate. However, the FDA believed at the time that the benefit of losing weight outweighed the risk of increased blood pressure and heart rate, he said.
The European Medicines Agency required Abbott to undertake the post-approval SCOUT trial, and in January that agency banned all anti-obesity drugs containing sibutramine.
In a related moved Friday, the FDA also warned consumers about another weight-loss drug, Slimming Beauty Bitter Orange Slimming Capsules, which contains the same active ingredient as Meridia -- sibutramine.
The capsules can cause the same cardiovascular problems as Meridia, the FDA said. Slimming Beauty is sold over the Internet by Beautiful Health Inc.
For more on the Slimming Beauty recall, visit the U.S. Food and Drug Administration.
SOURCES: Oct. 8, 2010, teleconference with John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, and Gerald Dal Pan, M.D., M.H.S., director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, both U.S. Food and Drug Administration
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