Rubber-Stoppered Vials Pose Latex Allergy Risk

A study has found that drugs stored in vials with a natural rubber stopper can be contaminated with latex allergens, no matter what precautions are taken. The study, conducted by researchers at Johns Hopkins University (Baltimore, MD, USA), was published in the June 2001 issue of the Journal of Allergy and Clinical Immunology.

The researchers are asking drug manufacturers to label all current vials as "containing natural rubber” where appropriate and to convert to synthetic rubber for all future medicine bottle stoppers. The study involved 12 allergic and 11 non-allergic volunteers. All underwent puncture and intradermal skin testing with solutions from drug vials, two with natural rubber latex stoppers and three with synthetic stoppers. Two latex-allergic subjects had skin reactions even when the rubber stopper was not punctured. Five had reactions when the stopper was punctured 40 times before testing, not an infrequent practice, since some vials contain multiple doses.

Non-allergic subjects had no reaction. Until the U.S. Food and Drug Administration (FDA) requires labeling of vials with rubber stoppers or requires that all stoppers be latex free, some sensitized individuals will be at risk for potentially serious or fatal allergic reaction. In the meantime, say the researchers, pharmacists need to contact the drug manufacturer, ask if a stopper is made of latex, and if necessary, ask the company if it can provide the pharmaceutical in a vial with a synthetic stopper.




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