2009年12月07日
米国消費者団体：抗肥満薬の販売停止をＦＤＡに要請！
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米国消費者団体がAbbott社の抗肥満薬の販売停止をFDAに要請！
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2009年12月3日、Abbott（アボット）社の抗肥満薬・Meridia（メリディア；sibutramine、シブトラミン）の有意な心臓発作・脳卒中・心停止・死亡リスク上昇が新たな研究で示されており、この薬剤を即刻販売停止すべきとの見解を米国消費者団体が発表しました。
この見解を発表したPublic Citizenは同日にアメリカFDA（米国食品医薬品局）にMeridiaの使用禁止を請願しました。Public Citizenは2005年にも同様の請願をしています。
（英文解説）
Petition to Ban Sibutramine (Meridia) ：December 3, 2009
This purpose of this letter is to re-petition the Food and Drug Administration (FDA) to immediately ban the weight loss drug, sibutramine (Meridia – Abbott – in the U.S.). Early results from SCOUT, a large, 10,000 person, international, randomized, placebo-controlled study mandated by the European Union (EU) and performed by Abbott as a condition of continued marketing of sibutramine in EU countries, have shown a significantly increased number of patients with heart attacks, strokes, resuscitated cardiac arrests or deaths in those who are obese and aged 55 or older with known or occult cardiovascular disease using sibutramine, compared with those given a placebo. Both groups were on the same weight management program.
The FDA has reported that 11.4% of patients getting sibutramine vs. 10 % of patients getting a placebo suffered a heart attack, stroke, resuscitated cardiac arrest or death, the primary pre-specified outcome of the study.[1] With 5,000 patients in each group, we have calculated that this results in a statistically significantly increased risk for the drug: p=0.026 (Fisher’s Exact test) with an excess of 70 patients in the sibutramine group having one of the above outcomes.
There has been a decrease over the past eight years in the use of sibutramine in the U.S. However, during the last 12 months, there were still 294,000 prescriptions filled in this country according to data from IMS. This emphasizes the urgency of banning the drug.
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