Cruz BMA, Rodríguez MBN, Furones MJA, Alfonso OI, Rodríguez PD

Language: Spanish
References: 10
Page: 20-28
PDF size: 64.08 Kb.

ABSTRACT

Introduction: the transfer factor is an immunologic stimulant used in a wide range of diseases. Its safety and efficiency have been evaluated in pre-registration clinical trials, but little is known about its safety margin under regular practical conditions, hence the need of closely watching its use and setting the benefit-risk relation.
Objectives: to identify adverse events in patients treated with the transfer factor and to determine the level of association of the drug and the observed adverse event and severity.
Methods: prospective, multicentered, descriptive and observational study of active drug surveillance. Two hundred and eighty two patients, who were attended by their physicians from April 2001 to April 2002 in 9 hospitals of Havana, were observed for one year after the end of a treatment with the transfer factor. The occurrence of adverse events as well as their severity, association with the drug, the number of events per patient, the supplied dosage and the age of the patient was all analyzed.
Results: in this group of patients, 13.8 % had at least one adverse effect; 38.5 % were aged 45 to 59 years. The treatment schemes with high and prolonged dosage did not cause any further event. Eighty adverse effects were identified, 55 % mild and 80 % were considered as unlikely related with the drug. None of them was definitive or probable whereas fever, arthralgia, dysnea, myalgia, allergy and asthenia were considered as possible mild adverse reactions.
Conclusions: most of adverse events during the year after the end of treatment with the transfer factor were mild and unrelated to the use of the drug. However, the drug manufacturers should advise professionals and patients on the possible occurrence of adverse reactions.

REFERENCES

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