title: Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury.
abstract: OBJECTIVE
  Previous publications have linked Herbalife® products to hepatotoxicity. The identification of earlier cases in which the culprit agent could not be established raised the hypothesis of a possible contamination of some specific batches of Herbalife products.
  
  
  METHODS
  We searched the Spanish Pharmacovigilance Centres' database of adverse reactions for reports of liver injury associated with the use of Herbalife products from 2003, when the first case was submitted, through September 2010.
  
  
  RESULTS
  The search resulted in 20 reports of liver damage (mean age, 49 years; 16 women), with 12 patients (60%) requiring hospitalization. Hepatocellular damage predominated, and nine (53%) of the hepatocellular cases with bilirubin values were jaundiced, fulfilling the Hy's law criteria, which increases the risk for serious outcomes. Two patients experienced a positive rechallenge. One patient developed cirrhosis, whereas all the others recovered. Causality assessment by the Karch and Lasagna modified algorithm showed a category of definite in 1 case, probable in 14, and possible in 5. Analysis of the different Herbalife products that each patient had taken did not enable us to identify any commonly known hepatotoxic ingredient.
  
  
  CONCLUSIONS
  Our results support the relationship between the consumption of Herbalife products and hepatotoxicity, underscore the concern regarding the liver-related safety of this dietary supplement, and emphasize the need to establish further regulatory measures.
authors.affiliation: Centro de Farmacovigilancia de Asturias, Facultad de Medicina, Universidad de Oviedo, Oviedo, Spain. gmanso@uniovi.es
authors.forename: Gloria
authors.initials: G
authors.lastname: Manso
authors.forename: Laureano
authors.initials: L
authors.lastname: López-Rivas
authors.forename: M Esther
authors.initials: ME
authors.lastname: Salgueiro
authors.forename: Jose M
authors.initials: JM
authors.lastname: Duque
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Jimeno
authors.forename: Raúl J
authors.initials: RJ
authors.lastname: Andrade
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Lucena
mesh_terms: D000328:Adult; D001663:Bilirubin / Q000378:metabolism; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology* / Q000209:etiology; D019587:Dietary Supplements / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D029789:Ephedra / Q000009:adverse effects; D005260:Female; D006801:Humans; D008099:Liver; D008103:Liver Cirrhosis / Q000453:epidemiology / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D013030:Spain / Q000453:epidemiology
chemical_list: C087890:Herbalife; D001663:Bilirubin