SAFETY OF CHEMONUCLEOLYSIS - ADVERSE-EFFECTS REPORTED IN THE UNITED-STATES, 1982-1991

This survey covers 121 ''serious'' and ''unexpected'' adverse events a fter treatment with chymodiactin (chymopapain for injection) among app roximately 135,000 patients in the United States. They were reported t o the Food and Drug Administration (FDA) within 15 days of notificatio n of the manufacturer between 1982 and the end of 1991. They included fatal anaphylaxis (seven cases), infections (24 cases), hemorrhage (32 cases), and neurologic (32 cases) and miscellaneous (15 cases) events , with a mortality rate of 0.019%. Anaphylactic reactions reported in a postmarketing survey can be attributed to chymopapain itself and inf ections to lack of asepsis during its administration. The causes of ot her adverse reactions cannot be as clearly defined, but many are unlik ely to have been due to chymopapain or its administration. More carefu l selection of patients and closer attention to technique during chemo nucleolysis have dramatically reduced the incidence of these adverse e vents, which occur far less frequently than after diskectomy.