EN — For dog owners. Dirlotapide is the active ingredient in Slentrol (dirlotapide) — EMEA/V/C/000116, a canine weight-loss medicine whose indication was As an aid in the management of overweight and obesity in adult dogs. In the EU its status is now Status: Withdrawn. But in the US FDA adverse-event database the molecule still shows Dirlotapide: 2994 reports, with top reported reactions including Vomiting 927. Two cautions: the counts are CUMULATIVE as of openFDA pull 2026-07-22, and "Lack of efficacy" terms denote product-performance reports, not adverse reactions. Most important: reported ≠ causal — a report does not prove the drug caused the event. Bottom line — the drug is off the EU market; its US report file stays on the books.
中文 — 给养狗主人。 Dirlotapide 是犬用减肥药 Slentrol (dirlotapide) — EMEA/V/C/000116 的有效成分,适应症为帮助管理成年犬超重与肥胖(原文:As an aid in the management of overweight and obesity in adult dogs)。它在欧盟的状态是 Status: Withdrawn(已撤市)。但在美国 FDA 不良事件数据库里仍有 Dirlotapide: 2994 条报告,最多报告的反应含 Vomiting 927(呕吐 927 例)。两点注意:计数是 CUMULATIVE as of openFDA pull 2026-07-22(累计快照);且"缺乏疗效"类术语是产品性能报告,不是不良反应("Lack of efficacy" terms denote product-performance reports, not adverse reactions)。最重要:reported ≠ causal(有报告 ≠ 有因果)。结论——药已在欧盟撤市,但美国的报告档案仍在。
Source article: dirlotapide-withdrawal-ade (built from C1-verified openFDA / EMA source topics).
Claims (verified as substrings of the C1-verified source article)
Slentrol (dirlotapide) — EMEA/V/C/000116As an aid in the management of overweight and obesity in adult dogsStatus: WithdrawnDirlotapide: 2994Vomiting 927CUMULATIVE as of openFDA pull 2026-07-22"Lack of efficacy" terms denote product-performance reports, not adverse reactionsreported ≠ causal