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April 20, 1984

Anaphylaxis From Chymopapain

Author Affiliations

Smith Laboratories, Inc Northbrook, Ill

JAMA. 1984;251(15):1953. doi:10.1001/jama.1984.03340390017013

To the Editor.—  Dr I. Leonard Bernstein's1 recent letter concerning the incidence of anaphylaxis and mortality during chemonucleolysis for herniated lumbar intervertebral disks was based in part on information also published in The Journal.2,3 An ongoing, postmarketing surveillance program initiated by Smith Laboratories at the time the Food and Drug Administration approved Chymodiactin, our formulation of chymopapain, has provided important data from an additional 18,323 patients that can now be added to the data from the approximately 1,600 patients who participated in our clinical trials before FDA release.First, none of the 18,323 patients described in the surveillance program as of Aug 29, 1983, has died of an allergic reaction, leading to an overall mortality rate for Chymodiactintreated patients of 0.01%. This is markedly reduced from the 0.15% mortality figure cited by Dr Bernstein and is considerably less than the 0.12% mortality reported for laminectomy (Acta Med Scand 1972;142:1-95).

Bernstein IL:  Adverse effects of chemonucleolysis .  JAMA 1983;250:1167-1168.Crossref
Gunby P:  Chymopapain: Tropical tree to surgical suite .  JAMA 1983;249:1115-1120.Crossref
Javid MJ, Nordby EJ, Ford LT, et al:  Safety and efficacy of chymopapain (chymodiactin) in herniated nucleus pulposus with sciatica: Results of a randomized, double-blind study .  JAMA 1983;249:2489-2494.Crossref
Gunby P:  What is intradiscal therapy, anyway?  JAMA 1983;249:1120-1123.Crossref