Background: The treatment used to combat acute
lymphoblastic leukemia (ALL) is multidrug; therefore it is important to use
active pharmacovigilance to detect, assess and analyze the likely adverse reactions
which may occur during the same period. Objective: To determine the
frequency of adverse reactions to chemotherapeutic drugs in children with ALL. Material
and Methods: Intensive
pharmacovigilance was used to record the reports of adverse reactions to vincristine, L-asparaginase
and the vincristine-L-asparaginase combination in children with ALL in a
paediatric hospital. For each notification, the adverse reactions were analyzed
in order to verify causality. Results: Forty patients
were evaluated. Twenty children were female (50.0%) and 20 were male (50%). The children had a mean age, weight and height (±standard deviation:
SD) of 8.1 (±3.4) years, 31.4 (±13.9) kg and 1.3 (±0.2) m, respectively.
Vincristine was administered to 19 patients, vincristine plus L-asparaginase
were given to 19 patients and only 2 patients used L-asparaginase.
One-hundred-ninety adverse reactions were detected in the patients, with an
average (±SD) of 4.8 (±2.6). Ondansetron
was the drug administered for the treating
of nausea and vomiting. One hundred eighty-one (95.3%) adverse reactions
were identified as “definite”, 5 (2.6%) as “probable” and 4 (2.1%) as
“doubtful”. Conclusions: There is a high incidence of adverse
reactions by the administration of vincristine and L-asparaginase; the
reactions of highest incidence were: nausea, vomiting, neutropenia, diarrhea,
constipation, mucositis, headache, and abdominal pain. It is important to
promote the detection, collection, reporting, assessment and treatment of ARD’s
in children. It is necessary to promote the conduct further studies on
pharmacovigilance with this type of treatments and to increase the duration of
the studies.