Drugs

FDA analysis shows body-building products labeled to contain steroid and steroid-like substances continue to inflict serious liver injury

FDA’s review of adverse event reports supports a relationship between the use of various body-building products suspected to contain steroids and serious liver injury requiring hospitalization. A majority of the cases involved elevated liver enzymes (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (AlkP)), which are indicators of liver injury. In some cases, consumers were taking multiple body-building products, which precludes the ability to limit the findings to a specific product or ingredient and raises the concern that the harmful effects may be caused by an interaction between the two products.

Drug-induced liver injury (DILI) is a known possible harmful effect of using anabolic steroid-containing products. In addition, anabolic steroids (or AAS) may cause other serious adverse effects such as abnormal fat and cholesterol in the blood, mood disorders, androgenic effects (acnes, baldness, excessive hair growth in females), gonadal suppression (decreased sperm count, testicular atrophy), and enlarged breasts.

The postmarketing safety review of adverse event reports submitted to FDA from July 1, 2009, to December 31, 2016, found 35 cases involving men (ages 20-48) presenting with serious liver injury (reported as hospitalization/life-threatening) associated with body-building products that are labeled or suspected to contain steroids or steroid alternatives. 

• 16 of the cases had sufficient data to lead us to conclude that the liver injury was related to the consumption of the product(s);
• 13 cases provided laboratory results indicating a relationship between the time of consumption of the body-building product(s) and the liver injury; and
• 6 cases provided information to support a possible relationship between the consumption of the body-building product(s) and the liver injury.

Note: Postmarketing data have limitations, and a systematic approach for assessing serious liver injury is limited by the clinical data that are available. It is often difficult to characterize the association between one specific muscle-building product and serious liver injury given that, in some cases, consumers were taking multiple muscle-building products. 

Year, Adverse Event Reported to FDASuspected muscle-building Product(s)
associated with liver injury
Company or Distributor (if known)
20095-Deca Zol, 19 Tren-BolNot specified
2010Epi-HardcoreNot specified
2010Super D2 HardcoreSynthetic Science Labs
2011Mass XtremeAmericell-labs
(VMG Global Inc.)
2011Novedex XT, Androbolin 350Gaspari Nutrition,
British Dragon Nutraceutical
2011SterodolPharmapro,Inc.
2011Incredible Bulk, Tren 2 XtremeSynthetic Science Labs
2012Beastdrol, Serious MassNot specified
2012RaptorNutraclipse, Inc.
2012, 2015Trimethyl ExtremeExtreme Performance Group
2012Super DMZ RxIronMag Labs
2013Muttant PlexxAmf, Inc.
2013Tamox - synthetic testosterone booster, protein powder - "Black Powder"Not specified
2013Amino Max, A-HD (androgenic estrogenic modulator testosterone booster), Thunderbal, Anabol Cuts (thermal-anabolic accelerator)Not specified
2013M-Drol, cycle assist, body milkCompetitive Edge Labs, LLC
2013Alpha M60, Epi-10LGI Supplements
20135-Deca ZolComplete Nutrition,
Legal Limit Labs
2014Mass DestructionBlunt Force Nutrition
2014MayhemBody Sport Science
2014Mass CarnageGoldstar Nutrition
2014Super DMZ 2.0Blackstone Labs
2014Wolverine Xtreme, Beast StackFlex Fitness Products
2014Halo suspension, Methyl Masterzine, PCT RevolutionHelica Pharm
2014MethastadrolHard Rock Corporate Headquarters,
Rock Hard Laboratories, LLC
2014Super DMZIronMag Labs
2014E-ShredNot specified
2014Testplex 450, Cellucor P6 extreme, Methyl-Tren 550Cellucor,
Genetech Pharma Labs
2014Epi-10LGI Supplements
2014Cannibal Pro Cutting StackDNA Anabolics
2014EpistaneNot specified
2014Xtreme DMZ (Dymethazine)Blackstone Labs
2015Super Tren-VWarrior Labz
2015M-Sten Extreme Mass BuilderIronMagLabs
2016Penta BuiltNot specified

 

Page Last Updated: 06/20/2017
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