Decreased Incidence and Mortality of Anaphylaxis to Chymopapain

A recognized side effect of chemonucleolysis is life-threatening anaphylaxis to chymopapain. In the clinical trials of chymopapain, 13 cases of anaphylaxis were reported in 1585 administrations (0.82%). Two patients died. Data from a postmarketing survey (48,239 questionnaires) were reviewed to identify factors influencing the incidence and severity of anaphylaxis. The results indicate the incidence of anaphylaxis decreased to 0.44% in the 1983–1984 period (126/23,736), a level significantly (P ≤ 0.001) below the incidence of 0.82% observed in initial clinical trials. Only three deaths from complications related to anaphylaxis occurred in approximately 75,000 administrations (producing 252 anaphylactic episodes) reported since DeceMDer 1982. The prophylactic use of antihistamines and pretreatment with intravenous fluids coincide with the dramatic reduction in mortality due to anaphylaxis. However, overdiagnosis of anaphylaxis in the clinical trials and avoidance of chemonucleolysis in patients with IgE antibodies to chymopapain may account, in part, for the reduction in incidence.

[1]  I. Bernstein,et al.  Prospective evaluation of chymopapain sensitivity in patients undergoing chemonucleolysis. , 1985, The Journal of allergy and clinical immunology.

[2]  M. Roizen,et al.  Adverse Reactions to Chemonucleolysis: Anesthetic Considerations , 1985, International anesthesiology clinics.

[3]  E. Calenoff,et al.  A Preoperative Chymopapain Sensitivity Test for Chemonucleolysis Candidates , 1984, Spine.

[4]  M. Brim,et al.  Chymodiactin Postmarketing Surveillance: Demographic and Adverse Experience Data in 29,075 Patients , 1984, Spine.

[5]  J. Kampine,et al.  Baroreceptor Reflex Control of Heart Rate during Isoflurane Anesthesia in Humans , 1984, Anesthesiology.

[6]  J. McCulloch,et al.  Anaphylactic reactions following the intradiscal injection of chymopapain under local anesthesia. , 1983, The Journal of bone and joint surgery. American volume.

[7]  J. Moss,et al.  Histamine release by narcotics and muscle relaxants in humans. , 1983, Anesthesiology.

[8]  R. Stoelting.  Allergic Reactions during Anesthesia , 1983, Anesthesia and analgesia.

[9]  R. Jacobs,et al.  Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. , 1981, The Journal of allergy and clinical immunology.

[10]  M F Roizen,et al.  Anesthetic Doses Blocking Adrenergic (Stress) and Cardiovascular Responses to Incision—MAC BAR , 1981, Anesthesiology.

[11]  P. Lieberman,et al.  Administration of Radiographic Contrast Media in High‐risk Patients , 1980, Investigative Radiology.

[12]  M. Javid.  Treatment of herniated lumbar disk syndrome with chymopapain. , 1980, JAMA.

[13]  B. Fredholm,et al.  Anaphylaxis and plasma catecholamines. , 1980, Life sciences.

[14]  W. Lorenz,et al.  Histamine release in clinical conditions. , 1978, The Mount Sinai journal of medicine, New York.

[15]  A. Martins,et al.  Double-blind evaluation of intradiscal chymopapain for herniated lumbar discs. Early results. , 1976, Journal of neurosurgery.

[16]  M. Roizen,et al.  Effects of Halothane on Plasma Catecholamines , 1974, Anesthesiology.

[17]  D. Cox,et al.  The analysis of binary data , 1971 .

[18]  L. Smith,et al.  Treatment of lumbar intervertebral disc lesions by direct injection of chymopapain. , 1967, The Journal of bone and joint surgery. British volume.

[19]  L. Smith.  ENZYME DISSOLUTION OF THE NUCLEUS PULPOSUS IN HUMANS. , 1964, JAMA.

[20]  M. Roizen,et al.  The effects of anesthesia, anesthetic adjuvant drugs, and surgery on plasma norepinephrine , 1984 .

[21]  N. Sunder,et al.  Hormonal and hemodynamic profile of an anaphylactic reaction in man. , 1981, Circulation.