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FDA发现某些膳食补充剂中含有类固醇而敦促其召回

FDA finding of steroids in certain dietary supplements triggers recall

2009-11-20 【发表评论】
中文 | ENGLISH | 打印| 推荐给好友


ST LOUIS (MD Consult) - On November 17, 2009, the US Food and Drug Administration (FDA) announced the recall of 5 dietary supplements (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) sold by IDS Sports. According to the FDA, the recalled products contain the following undeclared substances, which the agency considers to be steroids: 'Madol,' 'Turinabol,' 'Superdrol,' and/or 'Androstenedione.'


Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include testicular shrinkage, male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and an increased risk of myocardial infarction, stroke, and death.


Although no illnesses or adverse events have been reported to the company to date in connection with the recalled products, customers who have these products in their possession are being advised to should stop using them immediately and contact their physician if they have experienced any problems that may be related to their use.


The recalled products listed below were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules:

 

Brand Name

Size

UPC

Lots

Bromodrol

1 box

6 75941 00250 7

All lots

Dual Action Grow Tabs

1 box

6 75941 00252 1

All lots

Grow Tabs

1 bottle 60 capsules

6 75941 00252 1

All lots

Mass Tabs

1 bottle 30 capsules

6 75941 00149 4

Purchased during or after 4/09

Mass Tabs

1 bottle 60 capsules

6 75941 00149 4

Purchased during or after 8/09

Ripped Tabs TR

1 box

6 75941 00162 3

Purchased during or after 12/08

Ripped Tabs TR

1 bottle 60 capsules

6 75941 00162 3

Purchased during or after 12/08

圣路易斯(MD Consult)——20091117日,美国食品药品管理局(FDA)宣布召回由IDS Sports公司售出的5种膳食补充剂(Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, Ripped Tabs TR)。据FDA表示,召回的产品中含有下列未申报的、当局归为类固醇成分的物质:“Madol”Turinabol“Superdrol”/雄烯二酮

 

使用含类固醇的产品可能会导致急性肝损伤。另外,类固醇还可能引起男性、女性以及儿童出现其他长期严重的不良后果,其中包括睾丸萎缩、男性不育症、女性男性化、男性乳房增大、儿童身材矮小、有较高的滥用其他药物或酗酒的倾向、血脂水平升高,以及心肌梗死、卒中和死亡的风险增加。

 

迄今为止公司尚未收到与召回产品有关的疾病或不良事件报告,但FDA建议拥有这些产品的消费者立即停用,而且若其发生过任何可能与这些产品使用相关的问题,则与应其医生取得联系。

 

下表所列召回产品的分销包装有2种,分别为装有60粒胶囊(泡罩包装)的黑盒和装有3060粒胶囊、有黑色标签的白瓶:

 

商品名

规格

药品条形码(UPC

批号

Bromodrol

1

6 75941 00250 7

所有批号

Dual Action Grow Tabs

1

6 75941 00252 1

所有批号

Grow Tabs

1(60粒胶囊)

6 75941 00252 1

所有批号

Mass Tabs

1(30粒胶囊)

6 75941 00149 4

094月或以后售出的

Mass Tabs

1(60粒胶囊)

6 75941 00149 4

098月或以后售出的

Ripped Tabs TR

1

6 75941 00162 3

0812月或以后售出的

Ripped Tabs TR

1(60粒胶囊)

6 75941 00162 3

0812月或以后售出的


Subjects:
general_primary
学科代码:
内科学

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疾病资源中心  疾病资源中心
 病例分析

 王燕燕 王曙

上海交通大学附属瑞金医院内分泌科

患者,女,69岁。2009年1月无明显诱因下出现乏力,当时程度较轻,未予以重视。2009年3月患者乏力症状加重,尿色逐渐加深,大便习惯改变,颜色变淡。4月18日入我院感染科治疗,诉轻度头晕、心慌,体重减轻10kg。无肝区疼痛,无发热,无腹痛、腹泻、腹胀、里急后重,无恶性、呕吐等。入院半月前于外院就诊,查肝功能:ALT 601IU/L,AST 785IU/L,TBIL 97.7umol/L,白蛋白 41g/L,甲状腺功能:游离T3 30.6pmol/L,游离T4 51.9pmol/L,心电图示快速房颤。
 

医学数据库  医学数据库



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