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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

CRUZ BARRIOS, María Aida et al. Adverse drug effects associated to the treatment of patients with transfer factor: City of Havana , 2004. Rev Cubana Farm [online]. 2006, vol.40, n.1. ISSN 0034-7515.

Transfer factor called Hebertrans is an immunostimulant used in a wide range of diseases. The safety of this drug has been assessed in several clinical assays prior to registration, but not in aftermarket research studies. Therefore, a multicenter observational study of active surveillance was carried out in patients treated with transfer factor in 11 hospitals located in the City of Havana to detect adverse events in the course of treatment, and then to classify them by cause and severity. Data was collected by the immunologist in each hospital and supervised by the pharmacological epidemiologist. During the treatment, information was gathered from 387 patients where 133 events were reported in 86 cases (22,2%). The most frequent were fever, pain, erythema at the site of injection, headache and diarrhea; 92,5% of events were slight. 27,8% of adverse events were definitively caused by the drug and mainly related to the route of administration. Transfer factor was a safe drug for the patients under observation

Palabras clave : Transfer factor; Hebertrans; adverse reactions; adverse events; Drug Surveillance; Pharmacological Epidemiology.

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