title: Severe hepatotoxicity following ingestion of Herbalife nutritional supplements contaminated with Bacillus subtilis.
abstract: OBJECTIVE
  Nutritional supplements are widely used. Recently, liver injury after consumption of Herbalife preparations was reported but the underlying pathogenesis remained cryptic.
  
  
  METHODS
  Two patients presented with cholestatic hepatitis and pruritus, and cirrhosis, respectively. Viral, alcoholic, metabolic, autoimmune, neoplastic, vascular liver diseases and synthetic drugs as the precipitating causes of liver injury were excluded. However, both patients reported long-term consumption of Herbalife products. All Herbalife products were tested for contamination with drugs, pesticides, heavy metals, and softeners, and examined for microbial contamination according to standard laboratory procedures. Bacteria isolated from the samples were identified as Bacillus subtilis by sequencing the 16S rRNA and gyrB genes.
  
  
  RESULTS
  Causality between consumption of Herbalife products and disease according to CIOMS was scored "probable" in both cases. Histology showed cholestatic and lobular/portal hepatitis with cirrhosis in one patient, and biliary fibrosis with ductopenia in the other. No contamination with chemicals or heavy metals was detected, and immunological testing showed no drug hypersensitivity. However, samples of Herbalife products ingested by both patients showed growth of Bacillus subtilis of which culture supernatants showed dose- and time-dependent hepatotoxicity.
  
  
  CONCLUSIONS
  Two novel incidents of severe hepatic injury following intake of Herbalife products contaminated with Bacillus subtilis emphasize its potential hepatotoxicity.
authors.affiliation: Institute of Clinical Pharmacology, University of Bern, Murtenstrasse 35, 3010 Bern, CH, Switzerland. felix.stickel@ikp.unibe.ch
authors.forename: Felix
authors.initials: F
authors.lastname: Stickel
authors.forename: Sara
authors.initials: S
authors.lastname: Droz
authors.forename: Eleonora
authors.initials: E
authors.lastname: Patsenker
authors.forename: Katja
authors.initials: K
authors.lastname: Bögli-Stuber
authors.forename: Beat
authors.initials: B
authors.lastname: Aebi
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Leib
mesh_terms: D000368:Aged; D001412:Bacillus subtilis / Q000302:isolation & purification*; D019587:Dietary Supplements / Q000009:adverse effects*; D005260:Female; D005506:Food Contamination; D016908:Gram-Positive Bacterial Infections / Q000150:complications; D006505:Hepatitis / Q000175:diagnosis / Q000382:microbiology*; D029001:Herbal Medicine; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000382:microbiology*; D008297:Male; D008875:Middle Aged