Primeau MN, Adkinson NF Jr, Hamilton RG, et al.
The Journal of allergy and clinical immunology. Date of publication 2001 Jun 1;volume 107(6):958-62.
1. J Allergy Clin Immunol. 2001 Jun;107(6):958-62. doi: 10.1067/mai.2001.115630.
Natural rubber pharmaceutical vial closures release latex allergens that produce
skin reactions.
Primeau MN(1), Adkinson NF Jr, Hamilton RG.
Author information:
(1)Division of Allergy and Clinical Immunology, Department of Medicine, Johns
Hopkins University School of Medicine, Baltimore, MD 21224, USA.
BACKGROUND: The release of allergenic proteins from natural rubber vial closures
(stoppers) into aqueous pharmaceuticals may induce allergic reactions in
individuals with latex allergy (LA) receiving medications from such vials.
OBJECTIVE: The goal of this study was to determine whether solutions stored in
vials containing natural rubber closures release allergenic proteins detectable
by skin testing of subjects with LA.
METHODS: Five pharmaceutical vial closures (2 natural rubber and 3 synthetic)
were coded, inserted onto vials containing phenol-saline-human serum albumin,
and stored in an inverted position before use. Twelve volunteers with and 11
volunteers without LA underwent skin testing with solutions from each of the 5
vials, either those not punctured (0P) or those punctured 40 times with a
21-gauge needle 12 to 24 hours before testing (40P).
RESULTS: All intradermal skin test responses in the group without LA were
negative. Two and 5 of the 12 subjects with LA had positive intradermal skin
reactions to 0P and 40P solutions, respectively, from vials containing rubber
closures. Two subjects with LA had inexplicable, positive, nonreproducible
intradermal skin test reactions to solutions from vials containing bromobutyl
but not vials with isoprene synthetic closures. In vitro inhibition analysis
detected 6 to 7 AU/g latex allergen in extracts of cut natural rubber containing
closures but not in extracts of synthetic closures.
CONCLUSION: Natural rubber vial closures released allergenic latex proteins into
the tested solutions in direct contact during storage in sufficient quantities
to elicit positive intradermal skin reactions in some individuals with LA. These
data support a recommendation to eliminate natural rubber from closures of
pharmaceutical vials.
DOI: 10.1067/mai.2001.115630
PMID: 11398071 [Indexed for MEDLINE]
