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Drug bottles containing natural rubber stoppers may place latex allergic patients at risk for reactions

Armed with evidence from a recent study of latex allergy skin reactions in patients, scientists at Johns Hopkins encourage the Food and Drug Administration (FDA) and drug makers to label all current vials as "containing natural rubber" where appropriate and convert to using synthetic rubber for all medicine bottle stoppers.

If a drug is sold and stored in vials with a natural rubber stopper, no matter what precautions you take, latex allergens can contaminate that drug, says Robert Hamilton, Ph.D., professor of medicine at Johns Hopkins University. The FDA has asked for evidence that such allergens are present in pharmaceutical vials and that they can induce reactions in individuals already allergic to latex. Now we can provide it to them. Until the FDA requires all vials to be labeled as "containing natural rubber" for easy identification and that the stoppers be latex free, some sensitized individuals will be at risk for a potentially serious or fatal allergic reaction. Hamilton and his team make these recommendations based on a new study, reported in the June issue of the Journal of Allergy and Clinical Immunology, of 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 individuals had skin reactions even when the rubber stopper was not punctured and five had reactions when the stopper was punctured 40 times before testing. It is not unusual for drug vials to be frequently punctured by syringe needles, since vials contain multiple doses. Non-allergic individuals were not similarly affected.

The evidence from this study indicates that these stoppers pose a risk for reactions, says Hamilton. Even without a complete switch to synthetic stoppers, short-term solutions may help avoid allergic reactions and save lives. Doctors and pharmacists can ask, for example, whether their patients ha
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Contact: Kate O'Rourke
korourke@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
7-Jun-2001


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