Posted 29 September 2011
This medical article concludes: ” 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.”
Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury.
Manso, G., López-Rivas, L., Salgueiro, M. E., Duque, J. M., Jimeno, F. J., Andrade, R. J. and Lucena, M. I.
Pharmacoepidemiology and Drug Safety Volume 20, Issue 10, pages 1080–1087, October 2011 (2011)
Pharmacoepidemiology and Drug Safety, 20: 1080–1087. doi:10.1002/pds.2180
1. Centro de Farmacovigilancia de Asturias, Facultad de Medicina, Universidad de Oviedo, Oviedo, Spain 2. Servicio de Digestivo, Hospital San Agustín, Avilés, Spain 3. Servicios de Ap Digestivo y Farmacología Clínica, Facultad de Medicina, Hospital Universitario Virgen de la Victoria, Málaga, Spain 4. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain
Email: Gloria Manso ([email protected])
*Correspondence: G. Manso, Centro de Farmacovigilancia de Asturias, Facultad de Medicina, Universidad de Oviedo, Julián Clavería 6, 33006 Oviedo, Spain. E-mail: [email protected]
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.
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.
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.
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.
Update 19 January 2015
Note: There have been a number of scientific arguments arguing whether Herbalife can be linked to liver toxicity. In essence the argument is that causality has to be proven by using a process that is the ‘gold standard’, i.e., re-exposure to the product. As this is very difficult to do, in many cases, although Herbalife is suggested to be the cause, one cannot say this with absolute certainty and therefore one can make this conclusion without some doubt. Here are a list of the articles published in PubMed where this is debated. One should remember that the company will do its damnest to defend its product. Saying that, the evidence has to be clear before a claim is made. Yes caution dictates that one cannot ignore strong evidence and hence a balance has to be found. I have not found a balanced review yet. Wikipedia attempts to.