Idiosyncratic drug-induced liver injury related to use of novel selective androgen receptor modulator RAD140 (Testalone): a case report

Abstract

Background RAD140 (Testalone) is a novel selective androgen receptor modulator with very limited data currently available on adverse effects related to this compound. The first-in-human phase 1 trial was recently published and did report a significant proportion of elevated aspartate aminotransferase, alanine transaminase, and total bilirubin among the test subjects. RAD140 may be associated with an idiosyncratic drug-induced liver injury. It is easily purchased online as a workout supplement. Given its ease of use from being an oral formulation, and not requiring a physician’s prescription, its use among the young male population will likely rise. Clinicians should ask about the use of RAD140, and other workout supplements, in young men presenting with acute liver injury. Case presentation We present the case of a 26-year-old Caucasian male without any significant past medical history who presented with nausea, vomiting, severe right upper quadrant abdominal pain, and jaundice from acute liver injury. Extensive inpatient workup did not reveal a definite cause for his liver injury other than the use of a novel selective androgen receptor modulator called RAD140 (Testalone). He was treated with supportive care and discharged after short hospitalization. He was instructed to stop RAD140, which he reported compliance with, and on 2-month follow-up his liver function panel had normalized without recurrence of any symptoms. Conclusion Novel selective androgen receptor modulators such as RAD140 may be associated with idiosyncratic drug-induced liver injury. Workup of new liver injury in young and middle-aged males should involve asking about use of these novel compounds, for if missed and use continues, it can likely lead to fulminant liver failure or decompensated liver cirrhosis.

Selective androgen receptor modulator use and related adverse events including drug-induced liver injury: Analysis of suspected cases

“…peak 73 IU/L); TB 0.8 mg/dL Negative No No medical history Not mentioned Arayangkool et al [ 46 ] LGD-4033 Ostarine RAD-140 Jaundice Pruritus Weight loss Abdominal pain Cholestatic liver injury Canalicular bile plugs Hepatocellular dropout Acute tubular injury with pigmented bile casts 8 weeks No AST 52 IU/L ALT 52 IU/L ALP 343 IU/L TB 43.3 mg/dL Negative No No medical history Analytical testing for SARMS not performed. Dose was not specified Reported biopsy Ladna et al [ 47 ] RAD-140 Nausea, vomiting, severe right upper quadrant abdominal pain, jaundice, dark urine, constipation Acute liver injury 8 weeks No AST 51 IU/L ALT 243 IU/L TB 4.9 mg/dL Negative No No medical history Analytical testing for SARMS not performed Mohamed et al [ 48 ] RAD-140 Jaundice, nausea, fatigue, dark urine, acholic light gray-colored stool, pruritus Mixed portal hepatitis, cholestasis, biliary reactive changes 16 weeks Performance-enhancing supplement AST 70.8 IU/L (1.18 µkat/L) ALT 99.6 IU/L (1.66 µkat/L) ALP 318 IU/L (5.3 µkat/L) TB 427.5 mg/dL Negative No No medical history Analytical testing for SARMS not performed. Dose was not specified Reported biopsy Cardaci et al [ 49 ] LGD-4033 10 mg daily Controlled study—not reported Controlled study—not reported 5 weeks …”