Resumen

Hepatotoxicity by drugs and dietary supplements (DDS) is a rare and unpredictable event buth with the risk of a life-threatening clinical course when it occurs. It may emerge despite intensive chemical, toxicological and observational studies that indicate no hepatotoxic signals. The suggest major clinical and regulatory issues that must be addressed in he area of accurate testing, reporting, and accessibility of reliable data. Consequently, in a clinical setting, safety concerns are key elements in the treatment of patients, and require that the diagnosis of DDS hepatotoxicity clearly be established. Casuality of DDS hepatotoxicity may be pursued using a diagnostic algorithm consisting of a pre-test, a main-test as the scale of the updated CIOMS (Council for International Organizations of Medical Sciences), and a post-test. The results of these test are included in the regulatory database freely accessible to the health and scientific community. With this diagnostic and regulatory algorithm the risk of migdiagnoses and inappropriate regulatory measures may be minimized and the safety improved. In conclusion, DDS hepatotoxicity is a rare but is a potentially life-threatening entity requiring a reliable diagnosis with the aid of a diagnostic algorithm, and a thorough pharmacovigilance evaluation by national and international health agencies. Safety aspects in DDS hepatotoxicity represent a major clinical and regulatory issue and should consequently be addressed.

Palabras clave: Hepatotoxicity drugs dietary supplements safety perspectives regulatory agencies.

2009-11-27   |   820 visitas   |   1 valoraciones

Vol. 8 Núm.3. Julio-Septiembre 2009 Pags. 184-195 Ann Hepatol 2009; 8(3)