Cruz BMA, Furones MJA, Medina MY, de la Fuente SI, Pérez NL, Díaz VY

Language: Spanish
References: 13
Page: 502-510
PDF size: 66.64 Kb.

ABSTRACT

Introduction: the transfer factor is an immunostimulant that is used to treat several diseases but its safety in the medical practice has not been assured yet. Objectives: to identify the adverse events occurred some years after the end of a transfer factor treatment and to determine the association of the use and the observed events.
Methods: observational active drug surveillance study. The universe of study was 413 patients who were treated with the transfer factor from 2001 to 2004 in eleven hospitals located in La Habana province. The observation period ranged 6 to 8 years after the treatment. The patients were interviewed at home on the occurrence of infections, cancer or any other events. If some death occurred, then a family member was interviewed to record the cause and the date of the decease.
Results: three hundred fifty six patients were interviewed; 66(18.53 %) stated at least one adverse event and 21(31.80 %) events occurred in over 60 years-old patients. Eighty seven adverse effects were recorded; 8 (9.20 %) comprised infections such as hepatitis B, hepatitis C, foliculosis, mononucleosis and warts, one (1.10 %) event corresponded to cancer and 78 (89.70 %) to other type of events. Their relationship with the administration of the drug was considered as conditional in 64 events (73.60 %) and as unlikely in 21 (24.10 %) events comprising infections and most of the fatal events.
Conclusions: the adverse events observed in the patients, some years after the end of the treatment with the transfer factor, were not considered to be related to the administration of this drug; however, they must be under surveillance since the information obtained from this study should be compared with the information collected by a higher number of observations and of controlled observational studies.

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