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 FDA | Suspected muscle-building Product(s) associated with liver injury | Company or Distributor (if known) |
|---|---|---|
| 2009 | 5-Deca Zol, 19 Tren-Bol | Not specified |
| 2010 | Epi-Hardcore | Not specified |
| 2010 | Super D2 Hardcore | Synthetic Science Labs |
| 2011 | Mass Xtreme | Americell-labs (VMG Global Inc.) |
| 2011 | Novedex XT, Androbolin 350 | Gaspari Nutrition, British Dragon Nutraceutical |
| 2011 | Sterodol | Pharmapro,Inc. |
| 2011 | Incredible Bulk, Tren 2 Xtreme | Synthetic Science Labs |
| 2012 | Beastdrol, Serious Mass | Not specified |
| 2012 | Raptor | Nutraclipse, Inc. |
| 2012, 2015 | Trimethyl Extreme | Extreme Performance Group |
| 2012 | Super DMZ Rx | IronMag Labs |
| 2013 | Muttant Plexx | Amf, Inc. |
| 2013 | Tamox - synthetic testosterone booster, protein powder - "Black Powder" | Not specified |
| 2013 | Amino Max, A-HD (androgenic estrogenic modulator testosterone booster), Thunderbal, Anabol Cuts (thermal-anabolic accelerator) | Not specified |
| 2013 | M-Drol, cycle assist, body milk | Competitive Edge Labs, LLC |
| 2013 | Alpha M60, Epi-10 | LGI Supplements |
| 2013 | 5-Deca Zol | Complete Nutrition, Legal Limit Labs |
| 2014 | Mass Destruction | Blunt Force Nutrition |
| 2014 | Mayhem | Body Sport Science |
| 2014 | Mass Carnage | Goldstar Nutrition |
| 2014 | Super DMZ 2.0 | Blackstone Labs |
| 2014 | Wolverine Xtreme, Beast Stack | Flex Fitness Products |
| 2014 | Halo suspension, Methyl Masterzine, PCT Revolution | Helica Pharm |
| 2014 | Methastadrol | Hard Rock Corporate Headquarters, Rock Hard Laboratories, LLC |
| 2014 | Super DMZ | IronMag Labs |
| 2014 | E-Shred | Not specified |
| 2014 | Testplex 450, Cellucor P6 extreme, Methyl-Tren 550 | Cellucor, Genetech Pharma Labs |
| 2014 | Epi-10 | LGI Supplements |
| 2014 | Cannibal Pro Cutting Stack | DNA Anabolics |
| 2014 | Epistane | Not specified |
| 2014 | Xtreme DMZ (Dymethazine) | Blackstone Labs |
| 2015 | Super Tren-V | Warrior Labz |
| 2015 | M-Sten Extreme Mass Builder | IronMagLabs |
| 2016 | Penta Built | Not specified |