Hypersensitivity reactions to the polysorbate contained in recombinant erythropoietin and darbepoietin (Case Report)

Steele, Richard; Limaye, Sandhya; Cleland, Bruce; Chow, Josephine; Suranyi, Michael

doi:10.1111/j.1440-1797.2005.00389.x

Cited by 73 publications

(42 citation statements)

References 18 publications

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“…Anaphylactoid reactions are clinically indistinguishable from anaphylaxis, but IgE antibody is not involved and histamine is released through other mechanisms. 6 However, in several cases where polysorbate 80 was determined to be the cause, the patients had positive reactions to the skin-prick test to this product; 7,8 this was not the case in the study by Brotherton and colleagues. Also, most case reports of anaphylactoid reactions involved receipt of larger doses of polysorbate 80 than the 50 µg present in the HPV vaccine.…”

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confidence: 94%

The human papillomavirus vaccine and risk of anaphylaxis

Halsey¹

2008

Canadian Medical Association Journal

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I n this issue of CMAJ, Brotherton and colleagues 1 report a comprehensive investigation revealing higher than expected rates of apparent anaphylaxis following vaccination with the quadrivalent human papillomavirus (HPV) vaccine in Australian children. The cause of these reactions remains somewhat unclear and needs further investigation. Of note, rates of anaphylaxis, if confirmed, may not be as high in other populations. Further investigations may assist in clarifying differences between the Australian study and other reports.The use of a review panel with broad expertise in vaccines, allergy, immunology and pediatrics by Brotherton and colleagues and their use of the Brighton collaboration definition of anaphylaxis strengthen the evidence that the reactions were indeed anaphylaxis. This also strengthens their conclusions that the rate of anaphylaxis in the Australian population following HPV vaccination was higher than the rates observed following other vaccinations.Before concluding that the HPV vaccine is associated with higher rates of anaphylaxis than other vaccines everywhere, cases in other populations should be reviewed. In the United States, 15 cases of anaphylaxis or anaphlyactoid reactions following HPV vaccination were reported to the Vaccine Adverse Events Reporting System in 2007. As of July 21, 2008, 11 cases have been reported in 2008. Over 13 million doses of this vaccine had been distributed as of the end of 2007. 2Although there may be underreporting, the rate of about one case per one million vaccinations is consistent with the rate of anaphylaxis following several other vaccines. Regardless of the true rate, the causes of rare serious adverse events should be identified and vaccines made as safe as possible to maximize benefits and maintain public confidence in vaccines and immunization programs.Differentiating hypersensitivity reactions from fainting and anxiety reactions can be difficult, especially in busy, schoolbased clinics. The Clinical Immunization Safety Assessment Network, sponsored by the US Centers for Disease Control and Prevention, has developed guidelines and an algorithm to assist clinicians in the assessment of suspected immediate hypersensitivity reactions and decision-making about administering subsequent doses of vaccine. 3Anaphylaxis that occurs within minutes of exposure is usually associated with pre-existing IgE antibodies induced by prior exposure to the allergen. Brotherton and colleagues speculate that the reactions observed could have been due to prior sensitization from yeast proteins in the hepatitis B vaccine or HPV antigens from prior infections. However, 5 of the 7 women developed anaphylaxis after the first dose of HPV vaccine and, for 4 of the women, the results of skin tests were negative for yeast, polysorbate 80 stabilizer and the HPV vaccine. Skin testing performed within a few weeks of exposure could result in false negative tests because of the time lag for host reconstitution of IgE antibodies that were consumed in the reaction. The women in the stu...

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confidence: 94%

The human papillomavirus vaccine and risk of anaphylaxis

Halsey¹

2008

Canadian Medical Association Journal

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“…There have been a number of reports of anaphylaxis or generalized hypersensitivity reactions occurring following the receipt of drugs that have implicated polysorbate 80 as the cause. [34][35][36][37] Aluminum adjuvants are not a documented cause of anaphylaxis. 38 The most common event that may be confused with anaphylaxis during an acute episode is syncope.…”

Section: Discussionmentioning

confidence: 99%

Anaphylaxis following quadrivalent human papillomavirus vaccination

Brotherton

Gold²,

Kemp³

et al. 2008

Canadian Medical Association Journal

102

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“…1a, the activity of pancreatin was preserved in the presence of Tween 80 even when the surfactant was added at a concentration 250-fold higher than its cmc (0.0020% w/v) in water (20). Moreover, the catalytic efficiency of the proteolytic enzyme remained unaltered following a 30-min incubation of the pancreatin-surfactant mixture at 40°C.…”

Section: Effect Of Non-ionic Surfactants On Pancreatin Proteolytic Acmentioning

confidence: 95%

Effect of Four Commonly Used Dissolution Media Surfactants on Pancreatin Proteolytic Activity

Guncheva

Stippler

2016

AAPS PharmSciTech

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Abstract.Proteolytic enzymes are often used in dissolution testing of cross-linked gelatin capsules that do not conform to the dissolution specification. Their catalytic activity, however, can be affected when they are added to a dissolution media containing solubility enhancers, such as surfactants. The aim of this study was to assess the activity of pancreatic proteases in presence of four commonly used surfactants. We found that pancreatin exhibits remarkable proteolytic activity in the presence of Tween 80, even at the concentrations as high as 250 times its critical micelle concentration (cmc) in water, whereas, Triton X-100 enhanced the proteolytic activity of pancreatin when added at concentrations above its cmc in water. Both surfactants are non-ionic surfactants. On the other hand, sodium dodecyl sulfate (SDS) and cetyltrimethylammonium bromide (CTAB), which are ionic surfactants, have a detrimental effect on the proteolytic activity of pancreatin. For example, a 50% reduction of the pancreatin activity was found in samples which contain a minor amount of SDS (0.05% w/v) in comparison to a surfactant-free reaction. Additionally, no activity was observed for the pancreatin-SDS samples which were incubated for 30 min at 40°C prior to testing. CTAB had an impact on pancreatin activity at concentrations higher than its cmc. Data from this manuscript can be used as a benchmark for optimization of the dissolution procedures that require use of both surfactants and enzymes.

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Hypersensitivity reactions to the polysorbate contained in recombinant erythropoietin and darbepoietin (Case Report)

Cited by 73 publications

References 18 publications

The human papillomavirus vaccine and risk of anaphylaxis

The human papillomavirus vaccine and risk of anaphylaxis

Anaphylaxis following quadrivalent human papillomavirus vaccination

Effect of Four Commonly Used Dissolution Media Surfactants on Pancreatin Proteolytic Activity

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