FDA(美國食品藥品監督管理局)建議通過減肥藥物QNEXA的核准!

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February 22, 2012 (Updated February 23, 2012) (Silver Spring, Maryland) — The Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee [1,2] voted overwhelmingly in favor of approving the obesity drug Qnexa (Vivus, Mountain View, CA), a combination of phentermine and controlled-release topiramate [3].

Specifically, the panel voted 20 to 2 in favor of approving Qnexa, stating that the risk/benefit ratio is appropriate in patients with a body-mass index (BMI) of >30 kg/m2 or >27 kg/m2 in patients with weight-related comorbidities. Despite some concerns over increases in heart rate, as well as concerns about potential birth defects in babies born to women taking the drug, particularly risks of cleft lip with or without palate, the panel felt the risks of untreated obesity outweighed these concerns.

孫銘聰醫師comment: 美國食品藥品監督管理局的內分泌新陳代謝藥物諮詢委員會,在考量了藥物的風險與好處後,以壓倒性的投票結果(20贊成,2反對),贊成通過QNEXA這個減肥藥物使用在BMI(體質量指數)大於等於30或BMI>27 且有體重相關的併發症的病患中。

這個藥物也是在FDA不斷的提高要求,也就是要做許多藥物的風險性研究的情況下,雖然經過多次的再審議與再做更多的研究結果下,終於成為目前唯二FDA可以使用在減肥的藥物(另外一個是羅氏鮮),許多藥物在前仆後繼的一一衝向FDA的審議,而大多數的藥物都屬於再審議或直接被打入冷宮的情況,現在終於有些改變了,繼之前介紹的減肥藥Qnexa的現況,現在可以說開花結果了,各位為體重不易減下而煩惱的朋友,現在也可以用更加輕鬆的方式來減輕體重了!