~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter 2004. Dec. Vol.8...2 1. Rituximab (Rituxan Mabthera )...2 2. Erythropoietin...2 3. RU-486(Mifepristone )...2 4. Levoxyl...3 5....3 Vioxx...4 ADR -Cox-2 Selective Inhibitors...8...13...17 Taiwan Relief Foundation National Reporting Center of Adverse Reactions in Taiwan
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ by 1. Rituximab (Rituxan Mabthera ) Biogen Idec and Genentech rituximab (Rituxan Roche MABTHERA SOLUTION FOR IV INFUSION) Rituximab CD20 B rituximab B rituximab B rituximab http://www.fda.gov/medwatch/safety/2004/safety04.htm#rituxan 2. Erythropoietin Ortho Biotech PROCRIT epoetin alpha PROCRIT 2 1 gm / dl PROCRIT 150 IU / 40,000 IU http://adr.doh.gov.tw/manage/data/b01/45.pdf 3. RU-486(Mifepristone ) Danco Laboratories (FDA) mifepristone RU-486( Mifepristone, Apano ) Danco Laboratories FDA ( FDA ) (Box Warning) 2 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ Danco Laboratories mifepristone ( mifepristone ) Phillip G. Stubblefield, Emergencies Diagnosis and Management (New York: McGraw-Hill, 2004), 65-86. ( ) http://www.fda.gov/medwatch/safety/2004/safety04.htm#mifeprex 4. Levoxyl Jones Pharma King Pharmaceuticals Levoxyl levothyroxine sodium Levoxyl Levoxyl http://www.fda.gov/medwatch/safety/2004/safety04.htm#levoxyl 5. Janssen Pharmaceutica Products, L. P. Johnson & Johnson Pharmaceutical Research & Development, L. L. C. REMINYL AMARYL REMINYL AMARYL REMINYL AMARYL / http://www.fda.gov/medwatch/safety/2004/safety04.htm#reminyl ADR E-mail E-mail adr@tdrf.org.tw Safety Newsletter 2004 Dec. Vol.8. 3
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ Vioxx (Rofecoxib Merck Sharp & Dohme ) ( ) Vioxx 1999 5 (non-steroidal anti-inflammatory 2003 drugs ; NSAID) 25.5 COX-1 COX-2 Vioxx 2 COX-2 Vioxx 2004 9 30 Vioxx Vioxx FDA (FDA, Office of Safety) - Polyp Prevention on VIOXX ; (David Graham) Vioxx Vioxx 25 30-40 % colorectal adenomas colorectal polys 1 Vioxx 1-5 APPROVe Adenomatous 2000 Vioxx (Placebo) 4 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ confirmed thrombotic cardiovascular events APPROVe 爲 Vioxx GI toxicity nonselective NSAID 1999 COX-2 VIGOR( VIOXX GI TXA 2 PGI 2 Outcome Research) 8076 Viox Vioxx 50 COX-2 Naproxen 1000 0.5-13 9 aspirin, antiplatelet, anticoagulants COX-2 Vioxx Naproxen COX-2 (CV risks) Naproxen Vioxx per 100 patient-years 1.67Naproxen per 100 patient-years 0.70 Vioxx Naproxen (relative 2.38 risk) FDA Naproxen 4,5 cardioprotective effect, Vioxx FDA Safety Newsletter 2004 Dec. Vol.8 5
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 8 2004 9 27 FDA APPROVe 2001 2 Vioxx FDA Vioxx ( 12.5mg/5ml, 25mg/5ml ) ( 50, 25, 12.5 mg/tab ) COX-2 Celecoxib, Rofecoxib, Valdecoxib 2005 Advisory committee COX-2 6 Vioxx COX-2 Rofecoxib, Etoricoxib, Lumiracoxib (EMEA ) 2004 10 6 Vioxx 2004 11 21 Committee of Proprietary Medicinal Products of the European Agency for the Evaluation of 10 1 Vioxx Celecoxib, Etoricoxib Parecoxib, Valdecoxib COX-2 Medicinal Products COX-2 target patients COX-2 populations 6 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ COX-2 3. Topol E. J. Failing the Public Health Rofecoxib, Merck, and the FDA. N Engl J Vioxx Med 2004; 351: 1707-09 Vioxx 4. FitzGerald G. A. Coxibs and Cardiovascular Disease. N Engl J Med 2004; 351:1709-11 5. Belton O, Byrne D, Kearney D, et al. Vioxx Cyclooxygenase-1 and 2-Dependent Prostacyclin Formulation in Patients With Class effect Atherosclerosis Circulation 2000; 102: 840-845 6. Bing R, Lomnicka M. Why Do Cyclooxygenase-2 Inhibitors Cause Cardiovascular Events? Journal of the American College of Cardiology 2002; 39: 521-522. 7. Mukherjee D, Nissen S, Topol E. Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors. JAMA 2001; 286: 954-959. 1. Bader F. Fenoverine: a two-step, double-blind and open clinical assessments of its smooth muscle synchronizing effects. Pharmatherapeutica 1986; 4(7): 422-8. 2. FDA Statement November 17, 2004 For immediate release FDA Statement on Vioxx and Recent Allegations and the Agency's Continued Commitment to Sound Science and Peer Review. available from: http://www.fda.gov/bbs/topics/news/2004/n EW01136.html 8. FDA News FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product September 30, 2004. available from: http://www.fda.gov/bbs/topics/news/2004/n EW01122.html 9. EMEA press release Oct.2004. EMEA statement following withdrawal of Vioxx (rofecoxib). 100 19-1 1 02 2358-7343 206 E-mail adr@tdrf.org.tw Safety Newsletter 2004 Dec. Vol.8 7
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ ADR -Cox-2 Selective Inhibitors 1 1,2 1 2 1 2 ( 1 2 ) ( NSAIDs) (3) cyclooxygenase ( 酶 COX COX-1 COX-2 (4) ) (5) arachidonic acid (6) PGG2 PGH2 (7) COX-2 specific inhibitors ( coxibs): 1 NSAIDs celecoxib rofecoxib ADR COX-1 COX-2 5 45 coxibs NSAIDs coxibs COX-2 COX-1 COX-2 rofecoxib NSAIDs meloxicam etodolac nimesulide COX-2 COX-2 coxibs celecoxib etoricoxib( ) 2004 rofecoxib 1-4 COX-2 93 11 COX-2 NSAIDs (1) ADR (2) 8 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ / ATC code meloxicam, etodolac, nimesulide, cele- Naranjo score coxib, etoricoxib, rofecoxib ( 9 ) (5-8 ) (1-4 (Naranjo score 0) 6 6 ( 0 ) A( ADR 10547 ) B( 240 114 COX-2 ) 126 4 ADR 130 ADR (61.9%) 64 60-80 (56.3%) Meloxicam Etodolac Nimesulide Celecoxib Rofecoxib (%) 88 3 3(2.4) 89 4 1 5(4.0) 90 3 1 4 2 10(7.9) 91 3 8 3 18 6 38(30.2) 92 3 7 1 3 11 25(19.8) 93 8 8 6 12 11 45(35.7) 7 9 7 13 12 48 (38.1) 17 15 3 25 18 78 (61.9) 20-29 1 1 2(1.6) 30-39 2 1 5 2 10(7.9) 40-49 2 1 1 4 2 10(7.9) 50-59 4 5 4 2 15(11.9) 60-69 3 7 4 11 8 33(26.2) 70-79 9 7 5 9 8 38(30.2) 80-89 3 3 2 5 13(10.3) 90-99 1 2 3(2.4) 1 1 2(1.6) ( ) 64 (28-85) 62 (30-81) 67 (48-78) 60 (23-90) 68 (34-91) 64 (23-91) Safety Newsletter 2004 Dec. Vol.8 9
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ nimesulide meloxicam etodolac celecoxib rofecoxib A 48 Edema/leg edema 3 2 4 2 11 Stroke 1 1 Nausea/vomiting/GI 1 4 4 2 5 16 distress/dyspepsia GI hemorrhage 1 4 1 6 Renal failure 1 1 1 5 5 13 Oliguria 1 1 B 82 Angioedema 1 1 TEN/SJS/suspect SJS/EM 2 1 3 1 7 Rash/erythema/urticaria/ dermatitis/blister 2 9 14 18 8 51 Acute generalized exanthematous pustulosis 1 1 Itchy sensation 1 2 1 4 Acute hepatitis 1 1 Abnormal liver function test 1 1 Urinary retention 1 1 Urinary incontinence 1 1 Leukopenia 2 2 Rhinorrhea 1 1 Tinnitus 1 1 Diarrhea 1 1 2 Weakness/malaise 1 1 2 Allergic reaction 1 1 Thirsty sensation 1 1 Headache 1 1 Acronumbness/oral numbness 1 1 2 63 4 34 24 1 0 0 14 0 49 24 3 9 12 0 1 1 5 2 15 16 6 5 5 0 1 0 7 3 5 13 0 6 6 1 0 0 1 0 12 2 1 1 0 0 0 0 1 0 1 2 0 2 0 0 0 0 1 1 0 10 0 0 10 0 0 0 0 0 10 130 14 57 57 2 2 1 29 6 92 10 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ COX-2 NSAIDs rofecoxib stroke A 48 (36.9%) 60 B 82 (63.1%) aspirin losartan stroke 63 (48.5%) rofecoxib 25 mg QD 16 (12.3%) 13 rofecoxib APPROVe (10%) 11 (8.5%) 6 (4.6%) 4 rofecoxib stroke ( aspirin losartan )Naranjo score 3 COX-2 COX-2 63 ( 7 7 - ADR ) COX-2 2 NSAIDs Vioxx ( 13 1 ) FDA 12 73 17 27.5 (National Cancer Institute NCI) 110 121 195 celecoxib 6 Adenoma Prevention with 75 Celecoxib (APC) (interim analysis) celecoxib 800 mg 400 mg ( ) aspirin () 3.4 2.5 Vioxx Safety Newsletter 2004 Dec. Vol.8 11
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 33 NCI 400 mg FDA 1. Roberts II LJ, Morrow JD. Analgesicantipyretic and anti-inflammatory agents and FDA drugs employed in the treatment of Gout. In: celecoxib Joel G, Hardman JG, Limbird LE, Gilman AG. Goodman and Gilman s the pharma- (1) cological basis of therapeutics- 10 th ed. Mc celecoxib (2) Graw-hill express 2001: 687-731. 2. Warner TD, Giuliano F, Vojnovic I, et al. Nonsteroid drug selectivities for cyclo- (3) oxygenase-1 rather than cyclooxygenase-2 (4)FDA are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl NSAIDs Acad Sci 1999; 96: 7563-8. 3. Davies NM, Jamali F. Cox-2 selective 8 inhibitors cardiac toxicity: getting to the heart of the matter. J Pharm Pharmaceut Sci 2004; 7: 332-6. 4. US FDA News - FDA Isues Public Health COX-2 Adviosry on VIoxx as its Manufacturer Voluntarily Withdraws the Product 9/30/2004. available from: http://www.fda.gov/bbs/topics/news/2004/n EW01122.html 5. ADR COX-2 specific inhibitors. 2004; 5: 8-17. (6. Naranjo CA, Busto U, Sellers EM, et al. A ) method for estimating the probability of adverse drug reactions. Clin Pharmaco Ther 1981; 30: 239-45. celecoxib 7. Kennedy DL, Goldman SA, Lillie RB. Spontaneous Reporting in the United States. In: Strom BL, ed. Pharmacoepidemiology England, John Wiley & Sons Ltd express; COX-2 2000: 151-74. 8. US FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex 12/7/2004. available from: http://www.fda.gov/bbs/topics/news/2004/ne w01144.htm 12 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 1, 2, 1, 1, 2 1, 1 2 1 2 ( 1 2 ) TCA (tricyclic and 2020 tetracyclic antidepressants) 15% 40 MAOI (monoamine oxidase 20 50 MAOI trazodone reuptake inhibitors) TCA amitriptyline maprotiline moclobemide inhibitors) SSRI (selective serotonin Safety Newsletter 2004 Dec. Vol.8 13
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ WHO causality fluoxetine 24 COSTART Coding Symbols for Thesaurus of Adverse 1-3 Reaction Terms 5 th SNRI (serotonin / norepinephrine reuptake % inhibitors) SSRI 1 92 83.6 TCA 2 5 4.6 13 11.8 23 20.9 SSRI 24 21.8 36 32.7 7 6.4 velafaxine 20 18.2 5 48.8 19.5 SSRI 47 42.7 62 56.4 1 0.9 ADR 3 2.7 10 9.1 1 0.9 91 93 5 17 15.5 77 70.0 110 2 1.8 1 2 14 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 43 110 15 62 12 10 56.4% 47 42.7% ADR 48.8 16 86 83.6% 3 10 1 6 17 77 TCA 44 ( Imipramine 26 Amitriptyline 11 Doxepin 5 Clomipramine 2 6 5.5 Maprotiline 1 ) 33 30.0 SSRI 36 Sertraline 17 60 54.5 8 7.3 Fluoxetine 13 Paroxetine 4 3 2.7 Citalopram 2 SNRI 18 2 1.8 Trazodone 7 Mirtazapine 4 43 39.1 Moclobemide 1 52 47.3 1 0.9 7 6.4 5 4.5 A 70 63.6 54.5% 30.0% B 37 33.6 3 2.7 7.3% 5.5% 72 65.5 15 13.6 47.3% 39.1% 5 4.5 63.6% A 18 16.4 33.6% B 65.5% 18 16.4 67 60.9 12 10.9 60.9% 13 11.8 COSTART Safety Newsletter 2004 Dec. Vol.8 15
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ ADR SSRI (%) TCA MAOI 43 39.1 15 13.6 FDA 12 10.9 10 9.1 Fluoxetine 10 9 8.2 8 7.3 2 1.8 2 1.8 / 2 1.8 2 1.8 1 0.9 1 0.9 3 2.7 1. Information Handbook International with Canadian and International Monographs. 2004-2005. 2. Robins LN, Regier DA. Psychiatric Disorders in America. The Epidemiologic Catchment Area Study. 1990; New York: The Free Press. 3. Williams JW, Jr., Mulrow CD, Cfiquette E, TCA Noel PH, Aguilar C, Cornell J. A 44 40% systematic review of newer pharmacotherapies for depression in adults: 3 evidence report summary. Ann Intern Med Imipramine 2000; 132: 743-56. 4. DSM-IV 2003: 163-200 5. ADR - TCA 6: 7-10. SSRI 6. 6: 11-15. 2004; 36 12 16 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 1 2 ( 1 2 ) (anaphylaxis anaphylactic reaction) E (IgE) IgE IgE ( ) 1 β-lactam ( penicillin cephalosporin ) penicillin 1 (anaphylactic shock) 20% (anaphylactoid reaction) (1~38 10 IgE ) (biphasic reaction) (radiocontrast agent contrast media) 1. (NSAIDs) 90% ( ) 2. 80% 3. Safety Newsletter 2004 Dec. Vol.8 17
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 45 4 14 13 4. 6 4 1 7 1 1 5 0.2 0.5 (1:1000) 5 (vasovagal reaction) 15 ( ) 0.1 0.2 1 2 5 10 β -tryptase 10 (1:10000) 1. B. A. (epinephrine): hydrocortisone 200~500 methylprednisolone 125~500 6 2, 3 27 C. H 1 30 diphenhydramine 25~50 4 6 18 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ D. H 2 ranitidine 12.5~50 8 24 cimetidine 300 6~8 E. β-agonist) ( salbutamol terbutaline (%) aminophylline 20 100 8 40 F. cagon) (glu 12 60 ) ( 0~19 1 5 20~29 2 10 (β-blocker) 30~39 1 5 40~49 2 10 50~59 1 5 60~69 ( 8 40 propranolol ) 70~79 5 25 1 (n=20) 1~5 5~15 (ug) (%) (45) Cephalosporin G. Cefazolin 2 Cefalexin 1 1 2 Cephradine 2 ringer s lactate Cefapirin 1 Penicillin Penicillin G 2 Ampicillin + cloxacillin* 1 (5~7 ) (25) Acetylsalicylate 2 H. Ketorolac 1 dopamine Sulpyrin 2 (25) 2~10 / / Diatrizoate- 3 2. Iopamidol- 2 (5) (4~10 / Glycopyrrolate + fentanyl + 1 ) thiamylal + atracurium * Safety Newsletter 2004 Dec. Vol.8 19
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 4 penicillin 89 93 6 ampicilin + cloxacillin 29 ( penicillin 14 15 ) 20 ( cefazolin 8 12 ) 60~79 cephalosporin 65% ( ) cefalexin ( ) 9 iopamidol 5 5 epinephrine cephalosporin penicillin aspirin diatrizoate iopamidol aspirin 3 45% 55% sulpyrin sulpyrin (aspirin) 1. acetaminophen 56% 2. penicillin 20 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ (n=29 (%) ) ( 13 (45) 13 451 781 7 9 950 000 2 3 300 000 4 201 781 16 (55) 9 4 3 Penicillin Asparginase Morphine Cephalosporins Vincristine Meperidine Sulfonamides Cyclosporin Codeine Chloramphenicol Methotrexate Human immunoglobulin Tetracycline 5-fluorouracil Insulin Quinolones Protamine Nitrofurantoin Procaine, Lidocaine Antithymocyte globulin Vancomycin Thiopental Dextran Itraconazole Corticosstroid NSAID Pancuronism Streptokinase Radiocontrast agent Suxamethonium Vaccine penicillin -lactam penicillins cephalosporins () 7,8 penicillin-cephalosporin 1. 2~16.5% Petz 15,708 cephaloridine, cephalexin, cephalothin, cefazolin, penicillin cephalosporin cefamandole 9 penicillins 8.1% 0.02% cephalosporins 6 100 Cephalosporin penicillins 1.9% Safety Newsletter 2004 Dec. Vol.8 21
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ cephalosporins NSAIDs 10,11 cephalosporin aspirin NSAIDs penicillins aspirin 10,11,12 19-22 penicillins COX-2 (cyclooxygenase-2) cephalosporins NSAIDs ( : celecoxib rofecoxib) 13 COX-2 penicillins NSAIDs cephalosporins aspirin NSAIDs 2. (NSAIDs) NSAIDs COX-2 NSAIDs NSAIDs NSAIDs 3. (radiocontrast NSAIDs agents) 14, 15 NSAIDs 30 16 (the 94% Netherlands 20 60% Pharmacovigilance Foundation) 5 23 1985~2000 NSAIDs 30 diclofenac ibuprofen naproxen 4~13% 0.7~3.1% 24 NSAIDs 17 Kemp penicillin 18 interleukin NSAIDs aspirin ibuprofen naproxen indomethacin NSAIDs 25 26 22 Safety Newsletter 2004 Dec. Vol.8
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ prednisolone 50 1 prednisolone 50 1 ~1diphenhydramine 50 (ephedrine) 25~50 interleukin 23, 27 4. (desensitization) 1. (cross reactivity) ( aspirin ) 2. () (angiotensin converting enzyme inhibitors, ACEI) II (angiotensin II receptor blocker;arb) ( - 1. Klauw MM, Wilson JH, Stricker BH. - ) associated anaphylaxis: 20 years of reporting in The Netherlands (1974~1994) and review of the literature. Clin Exp Allergy 1996; 26(12): 1355-1363. (monoamine oxidase inhibitor MAOI) 2. Phil Liberman. Use of epinephrine in the treatment of anaphylaxis. Curr Opin Allergy Clin Immunol 2003; 3: 313-318. 3. Mclean Tooke. Adrenaline in the treatment of anaphylaxis: what is the evidence? BMJ 2003; 3. 327(7427): 1332-1335. 4. Soreide E, Buxrud T, Harboe S. Severe anaphylactic reactions outside hospital: aeitology, symptoms and treatment. Acta 7 13 anaesthesiol Scand 1998; 32: 339-342. Safety Newsletter 2004 Dec. Vol.8 23
~~~~~~~~~~~~~~~~~~~~~~~~~~ Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 5. Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med 1992; 327: 380-384. 6. Richard S Krause, MD. E-Medicine World Medical Library. http://www.emedicine.com/emerg/topic25.h tm 7. Anderson JA. Cross-sensitivity to cephalosporins in patients allergic to penicillin. Pediatr Infect Dis 1986; 5: 557-561. 8. Saxon A. Antibiotic choice for the penicillin-allergic patient. Postgrad Med 1988; 83: 135-148. 9. Petz LD. Immunologic cross-reactivity between penicillins and cephalosporins. J Infect Dis 1978; 137(suppl): S74-S79. 10. Shepherd GM. Allergy toβ-lactam antibiotics. Immunol Allergy Clin N Am 1991; 11: 611-633. 11. Anne S, Reisman RE. Risk of administering cephalosporin antibiotics to patients with histories of penicillin allergy. Ann Allergy Asthma Immunol 1995; 74: 167-170. 12. Solley GO, Gleich GJ, Van Dellen RG. Penicillin allergy: clinical experience with a battery of skin-test reagents. J Allergy Clin Immunol 1982; 69: 238-44. 13. Kelkar,Pramod S. Li, James TC. Cephalosporin allergy. N Eng J Med 2001; 345(11): 804-809. 14. Jennfer Altamura Namazy, MD, Ronald A.Simon,MD. Sensitivity to nonsteroidal anti-inflammatory drugs. Ann Allergy Asthma Immunol 2002; 89: 542-550. 15. Manning ME, Stevenson DD. Pseudoallergic drug reactions. Aspirin, nonsteroidal anti-inflammatory drugs, dye, additives, and preservatives. Immunol Allergy Clin North Am 1991; 11: 659-663. 16. Bosso JV, Schwartz LB, Stevenson DD. Tryptase and histamine release during aspirin-induced respiratory reactions. J Allergy Clin Immunol 1991; 88: 830-837. 17. Eugene P van Puijenbroek, Antoine CG Egberts, Ronald HB Meyboom et al. Different risks for NSAIDs-induced anaphylaxis. Ann Pharmacother 2002; 36: 24-29. 18. Kemp SF, Lockey RF, Wolf BL, et al. Anaphylaxis a review of 266 cases. Arch Intern Med 1995; 155: 1749-1754. 19. Stevenson DD, Simon R. Lack of cross-reactivity between rofecoxib and aspirin in aspirin-sensitive patients with asthma. J Allergy Clin Immunol 2001; 108: 47-51. 20. Eva A Berkes. Anaphylactic and anaphylactoid reactions to aspirin and other NSAIDs. Clin Rev Allergy Immunol 2003; 24(2): 137-148. 21. Woessner KM et al. The safety of celecoxib in patients with aspirin-sensative asthma. Arthritis Rheum 2002; 46: 2201-2206. 22. Quiralte J et al. Safety of selective cyclooxygenase-2 inhibitor rofecoxib in patients with NSAID-induced cutaneous reactions. Ann Allergy Asthma Immunol 2002; 89: 63-71. 23. J.B.Hagan. Anaphylactoid and adverse reactions to radiocontrast agents. Immunol Allergy Clin N Am 2004; 24: 507-519. 24. Lasser EC. Pseudoallergic drug reactions. Radiographic contrast media. Immunol Allergy Clin North Am 1991; 11: 645-651. 25. Greenberger PA, Patterson R. the prevention of immediate generalized reactions to radiocontrast media in high-risk patients. J Allergy Clin Immunol 1991; 87(4): 867-872. 26. Hong SJ, wong JT. Reactions to radiocontrast media. Allergy asthma Proc 2002; 23(5): 347-351. 27. Webb JA, Stacul F, Thomsen HS, Morcos SK. Late advere reactions to intravascular iodinated contrast media. Eur Radiol 2003; 13(1): 181-184. 19-1 1 02 2358-7343 02 2396-0100 02 2358-4100 http://www.tdrf.org.tw http://adr.doh.gov.tw 2281 24 Safety Newsletter 2004 Dec. Vol.8