"However, based on the serious nature of the review findings, the FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," the Medwatch alert stated.

“然而，鉴于后果严重，FDA要求制造商在西布曲明的药品标签上加上新的禁忌症。”药品监督网如是说。

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The FDA defends its own use of the data for safety surveillance and it issues frequent MedWatch alerts on potential problems.

WSJ: Searching for Side Effects