FDA will not ban Meridia, will monitor study of diet drug's risk

By Hubert Vigilla

Published on August 17, 2005

Public Citizen, a consumer group, petitioned the FDA to ban Meridia stating that users in their 20s and 30s died from heart problems caused by the prescription diet drug. The group contended that the FDA was aware of Meridia's effects on patient's blood pressure even before the drug was approved. Another complaint against Meridia came from David Graham, a drug safety officer for the FDA. In testimony before Congress last fall, Graham stated that the FDA allowed Meridia as well as four other dangerous drugs to remain on the market.

The FDA's review of the proposed ban ruled that the weight-loss benefits outweighed the perceived heart risks since cardiovascular diseases are commonly associated with obesity. Abbott Laboratories, manufacturers of Meridia, made the FDA's announcement public on Wednesday. The company estimates that since 1997, some 15 million patients in more that 75 countries have taken Meridia.

In the meantime, the FDA is tracking the results of a current Meridia study in Europe that is monitoring 9,000 obese subjects at high risk for cardiovascular disease. Half of the subjects are taking Meridia while the other half are on a placebo. The subjects are being monitored monthly to ensure their safety throughout the study.

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