Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication

Bibliography

• Crown J, O'Leary M, Ooi WS. Docetaxel and paclitaxel in the treatment of breast cancer: a review of clinical experience. Oncologist 2004;9(Suppl 2):24-32
   PubMed Web of Science ®Google Scholar
• Marupudi NI, Han JE, Li KW, Paclitaxel: a review of adverse toxicities and novel delivery strategies. Expert Opin Drug Saf 2007;6(5):609-21
   PubMed Web of Science ®Google Scholar
• Spencer CM, Faulds D. Paclitaxel. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in the treatment of cancer. Drugs 1994;48(5):794-847
   PubMed Web of Science ®Google Scholar
• Moon C, Verschraegen CF, Bevers M, Use of docetaxel (Taxotere) in patients with paclitaxel (Taxol) hypersensitivity. Anticancer Drugs 2000;11(7):565-8
   PubMed Web of Science ®Google Scholar
• Zanotti KM, Markman M. Prevention and management of antineoplastic-induced hypersensitivity reactions. Drug Saf 2001;24(10):767-79
   PubMed Web of Science ®Google Scholar
• Taxotere Prescribing Information. Sanofi-Aventis US LLC. Bridgewater, NJ; 2010
   Google Scholar
• Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001;37(13):1590-8
   PubMed Web of Science ®Google Scholar
• Szebeni J, Alving CR, Savay S, Formation of complement-activating particles in aqueous solutions of Taxol: possible role in hypersensitivity reactions. Int Immunopharmacol 2001;1(4):721-35
   PubMed Web of Science ®Google Scholar
• Szebeni J, Muggia FM, Alving CR. Complement activation by Cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study. J Natl Cancer Inst 1998;90(4):300-6
   PubMed Web of Science ®Google Scholar
• Weiss RB, Donehower RC, Wiernik PH, Hypersensitivity reactions from taxol. J Clin Oncol 1990;8(7):1263-8
   PubMed Web of Science ®Google Scholar
• Shepherd GM. Hypersensitivity reactions to chemotherapeutic drugs. Clin Rev Allergy Immunol 2003;24(3):253-62
   PubMed Web of Science ®Google Scholar
• ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003;42(7):665-85
   PubMed Web of Science ®Google Scholar
• Engels FK, Mathot RA, Verweij J. Alternative drug formulations of docetaxel: a review. Anticancer Drugs 2007;18(2):95-103
   PubMed Web of Science ®Google Scholar
• Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001;10(6):483-6
   PubMed Web of Science ®Google Scholar
• Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf 2003;26(3):159-86
   PubMed Web of Science ®Google Scholar
• Denman JP, Gilbar PJ, Abdi EA. Hypersensitivity reaction (HSR) to docetaxel after a previous HSR to paclitaxel. J Clin Oncol 2002;20(11):2760-1
   PubMed Web of Science ®Google Scholar
• Fader AN, Rose PG. Abraxane for the treatment of gynecologic cancer patients with severe hypersensitivity reactions to paclitaxel. Int J Gynecol Cancer 2009;19(7):1281-3
   PubMed Web of Science ®Google Scholar
• Kloover JS, den Bakker MA, Gelderblom H, van Meerbeeck JP. Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens. Br J Cancer 2004;90(2):304-5
   PubMed Web of Science ®Google Scholar
• Lehoczky O, Bagameri A, Udvary J, Pulay T. Hypersensitivity reactions in paclitaxel treatment of ovarian cancer patients. J Obstet Gynaecol 2002;22(3):312-13
   PubMedGoogle Scholar
• Micha JP, Goldstein BH, Birk CL, Abraxane in the treatment of ovarian cancer: the absence of hypersensitivity reactions. Gynecol Oncol 2006;100(2):437-8
   PubMed Web of Science ®Google Scholar
• Prieto Garcia A, Pineda de la Losa F. Immunoglobulin E-mediated severe anaphylaxis to paclitaxel. J Investig Allergol Clin Immunol 2010;20(2):170-1
   PubMed Web of Science ®Google Scholar
• Priore GD, Smith P, Warshal DP, Paclitaxel-Associated hypersensitivity reaction despite high-dose steriods and prolonged infusions. Gynecol Oncol 1995;56(2):316-18
   PubMed Web of Science ®Google Scholar
• van Herpen CM, van Hoesel QG, Punt CJ. Paclitaxel-induced severe hypersensitivity reaction occurring as a late toxicity. Ann Oncol 1995;6(8):852
   PubMed Web of Science ®Google Scholar
• Hauben M. A brief primer on automated signal detection. Ann Pharmacother 2003;37(7-8):1117-23
   PubMed Web of Science ®Google Scholar
• Ardavanis A, Tryfonopoulos D, Yiotis I, Non-allergic nature of docetaxel-induced acute hypersensitivity reactions. Anticancer Drugs 2004;15(6):581-5
   PubMed Web of Science ®Google Scholar
• Dizon DS, Schwartz J, Rojan A, Cross-sensitivity between paclitaxel and docetaxel in a women's cancers program. Gynecol Oncol 2006;100(1):149-51
   PubMed Web of Science ®Google Scholar
• Castells MC, Tennant NM, Sloane DE, Hypersensitivity reactions to chemotherapy: outcomes and safety of rapid desensitization in 413 cases. J Allergy Clin Immunol 2008;122(3):574-80
   PubMed Web of Science ®Google Scholar
• Feldweg AM, Lee CW, Matulonis UA, Castells M. Rapid desensitization for hypersensitivity reactions to paclitaxel and docetaxel: a new standard protocol used in 77 successful treatments. Gynecol Oncol 2005;96(3):824-9
   PubMed Web of Science ®Google Scholar
• Lee CW, Matulonis UA, Castells MC. Rapid inpatient/outpatient desensitization for chemotherapy hypersensitivity: standard protocol effective in 57 patients for 255 courses. Gynecol Oncol 2005;99(2):393-9
   PubMed Web of Science ®Google Scholar
• Bennett CL, Adegroro OS, Calhoun E, Raisch DW. Beyond the black box: drug- and device-associated hypersensitivity events. Drug Healthc Patient Saf 2010;2:1-5
   Google Scholar
• Kwon JS, Elit L, Finn M, A comparison of two prophylactic regimens for hypersensitivity reactions to paclitaxel. Gynecol Oncol 2002;84(3):420-5
   PubMed Web of Science ®Google Scholar
• Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009;32(1):19-31
   PubMed Web of Science ®Google Scholar
• Hsia CC, Zurawska JH, Tong MZ, Recombinant activated factor VII in the treatment of non-haemophilia patients: physician under-reporting of thromboembolic adverse events. Transfus Med 2009;19(1):43-9
   PubMed Web of Science ®Google Scholar
• Irujo M, Beitia G, Bes-Rastrollo M, Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf 2007;30(11):1073-82
   PubMed Web of Science ®Google Scholar
• Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007;16(2):223-8
   PubMed Web of Science ®Google Scholar
• Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf 2006;29(5):385-96
   PubMed Web of Science ®Google Scholar
• Mittmann N, Knowles SR, Gomez M, Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf 2004;27(7):477-87
   PubMed Web of Science ®Google Scholar
• Backstrom M, Mjorndal T, Dahlqvist R. Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 2004;13(7):483-7
   PubMed Web of Science ®Google Scholar
• van der Heijden PG, van Puijenbroek EP, van Buuren S, van der Hofstede JW. On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios. Stat Med 2002;21(14):2027-44
   PubMed Web of Science ®Google Scholar
• Irizarry L, Luu T, McKoy J, Cremophor EL-containing paclitaxel induced anaphylaxis: a call to action. Community Oncol 2009;8(3):133-4
   Google Scholar