FDA警告市面上有假冒ADHD药物Adderall
2012-06-01
来源：爱唯医学网
2012年5月29日，美国食品药品管理局(FDA)发出警告，称梯瓦制药生产的Adderall 30 mg片剂的假冒产品已经在市场上出现，通过互联网售卖。Adderall是一种被批准用于治疗注意缺陷多动障碍(ADHD)和发作性睡病的处方药，并且是一种受管制药物。
FDA的初步实验室检查显示，假冒Adderall含有错误的活性成分。正宗Adderall含有4种活性成分：右旋安非他命蔗糖盐、安非他命天门冬氨酸、右旋安非他命硫酸盐，以及安非他命硫酸盐。而假冒产品除了这些活性成分之外，还含有曲马多和对乙酰氨基酚。
Adderall目前在FDA的短缺药物名单上，其供应不足是由制药原料供应问题引起的。不法网站和经销商可能专门伪造紧缺的药物。
假冒Adderall片剂为白色圆形药片，没有任何类型的标记，如字母或数字。它们可能采用泡罩包装，包装上可能存在拼写错误。梯瓦制药生产的正宗Adderall 30 mg片剂为橙色/桃色圆形药片，一侧刻有dp浮雕，另一侧刻有“30”字样。正品的包装只有一种，即100片装药瓶，标签上有国家药品代码0555-0768-02。FDA新闻通稿中有假冒产品和正宗产品的图片。
ST LOUIS (MD Consult) - On May 29, 2012, the US Food and Drug Administration (FDA) issued a warning that a counterfeit version of Teva's Adderall in 30-mg tablets has emerged in the marketplace via purchases made through the Internet. Adderall is a prescription drug approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, and is considered a controlled substance.
Preliminary laboratory tests conducted by the FDA revealed that the counterfeit version of Adderall contained the wrong active ingredients. Authentic Adderall contains 4 active ingredients: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen.
Currently on the FDA's drug shortage list, Adderall is in short supply as a result of active pharmaceutical ingredient supply issues. Rogue Websites and distributors may especially target medicines in short supply for counterfeiting.
The counterfeit Adderall tablets are round and white, and do not have any type of markings, such as letters or numbers. They may be packaged in blister packs, and the packaging may contain misspellings. Authentic Adderall 30-mg tablets produced by Teva are round, orange/peach in color, and scored with dp embossed on 1 side and 30 on the other side of the tablet. Teva's Adderall 30-mg tablets are packaged only in 100-count bottles with the National Drug Code 0555-0768-02 listed on the label. Pictures of the counterfeit and authentic products may be viewed on the FDA press release.
The counterfeit versions of Adderall should be considered as unsafe, ineffective, and potentially harmful. Adverse reactions experienced with the use of suspected counterfeit products should be reported to the FDA's MedWatch Adverse Event Reporting Program.
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