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I. Introduction

WHEN 1997 began there was great optimism because, for the first time in 25 yr, a new drug for the treatment of obesity had been approved by the US Food and Drug Administration (FDA) in April 1996, and two more drugs were beginning their way through the approval process (1). As the year closed this optimism had been dashed by three events. The first was the report in July and publication in August of 24 women who had developed an unusual form of valvular heart disease while being treated with fenfluramine and phentermine (2). From the initial report, the number of patients with this problem grew until the only prudent move was to withdraw fenfluramine and dexfenfluramine from the market. This happened on September 15, 1997. The second event was the temporary withdrawal of the new drug application for orlistat, a drug that blocks intestinal lipase and produces weight loss. The third event was the delay in the marketing of sibutramine, which had received a letter of approval from the FDA and had originally been planned for marketing in late 1997.

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