Reacciones adversas a L-asparaginasa en pacientes con leucemia linfoblástica aguda / Adverse reactions to L-asparaginase in children with acute lymphatic leukemia

ABSTRACT

Background: The low notification of Adverse Drug Reactions (ADR) underscores the need for pharmacological surveillance systems that allow their detection, evaluation, prevention and registry especially in patients receiving multiple medications. Aim: To communicate the ADR observed with the use E coli asparaginase (E coli ASP) in children with Acute Lymphatic Leukemia (ALL). Patients and Methods: Cross-sectional study of clinical records of all the patients aged less than 15 years with ALL (n =52) and treated between January 1996 and April 2000. The suspicion of ADR to E coli ASP was evaluated using the Karch and Lasagna algorithm. Probable and definitive cases of ADR to E coli ASP were subjected to a protocol of clinical and epidemiological data. The risk factors associated to ADR to E coli ASP, were also determined. Results: Fifty children aged 1 to 13 years (33 men) were studied. In 20 (40 percent), an ADR to E coli ASP, was suspected. After the use of the algorithm, the ADR was considered definite in two patients, probable in 17 and possible in one. The registered clinical events were urticaria in 17, anaphylactic shock in four, transient alterations of hepatic functions test in seven and hypofibrinogenemia in four. The test of cutaneous sensitivity to the administration of E coli ASP, performed prior to the administration of the drug, were positive in nine of the 20 children with adverse reactions. No children died. Conclusions: The application of the Karch anbd Lasagna algorithm, allowed us to objectively classify suspected cases of ADR by E coli ASP.