Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients.
Postmarketing surveillance data on 29,075 patients who received Chymodiactin (Smith Laboratories' formulation of chymopapain) intradiscal injections for a herniated lumbar intervertebral disc are summarized and tabulated. The serious adverse reactions reported include death, anaphylaxis, paraplegia, and discitis. Similar problems also have been reported for Discase (Baxter-Travenol's formulation of chymopapain). Of 11 deaths reported following Chymodiactin administration, only 3 appear to be related to the drug or procedure. Two of these three were due to anaphylaxis and the third to bacterial discitis with resultant meningitis. Paraplegia appeared to be primarily due to needle trauma or injection of contrast agent and enzyme into the subarachnoid space. Careful patient selection and needle placement are essential for avoiding serious problems.
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000707:Anaphylaxis / Q000139:chemically induced; D001424:Bacterial Infections / Q000209:etiology; D002917:Chymopapain / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002927:Cimetidine / Q000627:therapeutic use; D004155:Diphenhydramine / Q000627:therapeutic use; D010450:Endopeptidases / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D011292:Premedication; D011358:Product Surveillance, Postmarketing
D000305:Adrenal Cortex Hormones; D002927:Cimetidine; D004155:Diphenhydramine; D010450:Endopeptidases; D002917:Chymopapain