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“膳食补充剂”因疑似含有类固醇而被召回

Suspicion of steroids in some 'dietary supplements' prompts recall

2009-11-09 【发表评论】
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ST LOUIS (MD Consult) - On November 3, 2009, the US Food and Drug Administration announced that Bodybuilding.com is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the company's Web site. The FDA has informed the company that it believes that the recalled products contain ingredients that should be classified as steroids.

 

Before Bodybuilding.com agreed to carry the recalled items, manufacturers assured the company that their products had been properly classified as dietary supplements in compliance with federal law—meaning that the products did not contain any unlawful ingredient. At this time, Bodybuilding.com has not had an opportunity to independently confirm the FDA's assertions that the recalled products do in fact contain steroids. However, the company is undertaking this voluntary recall in light of this possible safety concern.

 

At this time, Bodybuilding.com has not received any reports of adverse events in connection with use of the recalled products. 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 atrophy and 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 increased risk of heart attack, stroke, and death.


Customers with any of the recalled products in their possession are being instructed to immediately discontinue use, and to contact their physician if they have experienced any problems that may be related to their use. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program
online, by telephone (1-800-FDA-1088), by fax to 1-800-FDA-0178, or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

The recalled products are listed below:

 

Recalled Product List

Brand Name

 

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge 

Ergopharm 6-OXO 

Ergopharm 6-OXO Extreme 

EST (aka Engineered Sports Technology) MethAnstance 

Extreme Labs Susto-Test Depot 

Fizogen ON Cycle II Hardcore 

G.E.T/ (Genetic Edge Technologies) SUS-500 

G.E.T/ (Genetic Edge Technologies) Tren-250 

Hardcore Formulations T-Roid 

I Force Nutrition 1,4 AD Bold 200 

I Force Dymethazine/Reversitol Combo Pack 

I Force Reversitol 

I Force Nutrition 17a PheraFLEX 

I Force Nutrition Dymethazine 

I Force Nutrition Methadrol 

IDS (aka Innovative Delivery Systems) Bromodrol 

IDS (aka Innovative Delivery Systems) Grow Tabs TR 

IDS (aka Innovative Delivery Systems) Mass Tabs 

IDS (aka Innovative Delivery Systems) Oxodrol Pro 

IDS (aka Innovative Delivery Systems) Ripped Tabs TR 

IDS (aka Innovative Delivery Systems) Rapid Release 

Ripped Tabs 

Kilo Sports Massdrol 

Kilo Sports Phera-Mass 

Kilo Sports Trenadrol 

Monster Caps Monster Caps 

Myogenix Spawn 

Nutra Coastal D-Stianozol 

Nutra Coastal H-Drol 

Nutra Coastal MDIT 

Nutra Coastal S-Drol 

Nutra Coastal Trena 

Performance Anabolics Methastadrol 

Performance Anabolics Tri-Methyl X 

Purus Labs E-pol Inslinsified 

Purus Labs Nasty Mass 

Rage RV2 

Rage RV3 

Rage RV4 

Rage RV5 

Redefine Nutrition Finaflex 550-XD 

Redefine Nutrition Finaflex Ripped 

Transform Supplements Forged Extreme Mass 

Transform Supplements Forged Lean Mass

圣路易(MD Consult) ­—— 2009113,美国食品药品管理局(FDA)宣布Bodybuilding.com正在全国甚至全球范围内主动召回通过该公司网站销售的65种膳食补充品,包括尚未过期的所有批次产品。FDA已正式通知该公司,FDA认为其所召回的产品含有应归为类固醇的成分。

Bodybuilding.com同意召回这些产品之前,生产厂家曾向该公司保证,依照相关联邦法律,其产品完全符合膳食补充剂的标准,即不含任何非法成分。到目前为止,Bodybuilding.com尚未找到机会独立开展研究以确认FDA得出的结论,即召回产品确实含有类固醇。但该公司已经对这一可能存在的安全性问题做出了回应,正在主动召回相关产品。

到目前为止,Bodybuilding.com尚未收到任何与召回产品相关的不良事件报告。急性肝损害是使用含类固醇产品后可能出现的已知副反应之一。此外,无论对于男性、女性或儿童,类固醇都可能导致其他危及健康的长期严重不良反应。其中包括睾丸萎缩和男性不育、女性男性化、男性乳房增大、儿童身材矮小、滥用其他药物和酒精的倾向增加、血脂水平紊乱以及罹患心脏病、卒中和出现死亡的风险增加。

现已召告消费者立即停止使用任何一种召回产品,一旦出现了可能与之相关的健康问题,应立即就医。还应将不良事件上报至FDAMedWatch不良事件在线报告系统,可在线报告,亦可致电(1-800-FDA-1088),或发传真至1-800-FDA-0178,或将邮资已付的FDA 3500表格邮寄至以下地址:MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

 

召回产品目录如下:

 召回产品目录

商品名

 

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge 

Ergopharm 6-OXO 

Ergopharm 6-OXO Extreme 

EST (aka Engineered Sports Technology) MethAnstance 

Extreme Labs Susto-Test Depot 

Fizogen ON Cycle II Hardcore 

G.E.T/ (Genetic Edge Technologies) SUS-500 

G.E.T/ (Genetic Edge Technologies) Tren-250 

Hardcore Formulations T-Roid 

I Force Nutrition 1,4 AD Bold 200 

I Force Dymethazine/Reversitol Combo Pack 

I Force Reversitol 

I Force Nutrition 17a PheraFLEX 

I Force Nutrition Dymethazine 

I Force Nutrition Methadrol 

IDS (aka Innovative Delivery Systems) Bromodrol 

IDS (aka Innovative Delivery Systems) Grow Tabs TR 

IDS (aka Innovative Delivery Systems) Mass Tabs 

IDS (aka Innovative Delivery Systems) Oxodrol Pro 

IDS (aka Innovative Delivery Systems) Ripped Tabs TR 

IDS (aka Innovative Delivery Systems) Rapid Release 

Ripped Tabs 

Kilo Sports Massdrol 

Kilo Sports Phera-Mass 

Kilo Sports Trenadrol 

Monster Caps Monster Caps 

Myogenix Spawn 

Nutra Coastal D-Stianozol 

Nutra Coastal H-Drol 

Nutra Coastal MDIT 

Nutra Coastal S-Drol 

Nutra Coastal Trena 

Performance Anabolics Methastadrol 

Performance Anabolics Tri-Methyl X 

Purus Labs E-pol Inslinsified 

Purus Labs Nasty Mass 

Rage RV2 

Rage RV3 

Rage RV4 

Rage RV5 

Redefine Nutrition Finaflex 550-XD 

Redefine Nutrition Finaflex Ripped 

Transform Supplements Forged Extreme Mass 

Transform Supplements Forged Lean Mass


Subjects:
general_primary, endocrinology, diabetes
学科代码:
内科学, 内分泌学与糖尿病

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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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