NATURAL RUBBER LATEX ALLERGY

FDA investigations, which ultimately identified natural latex/natural rubber (NLNR) allergy as an emerging public health concern, were started in response to voluntary reports submitted by physicians, nurses, and technologists to medWatch. The first reports described patient deaths that occurred during barium enema procedures, before the administration of barium. These initial voluntary reports from vigilant and concerned health professionals provided critical information that resulted in the identification of NLNR allergy as the probable cause of the events. Additional reports received in response to a special FDA request for any information related to NLNR problems enabled FDA to issue a Medical Alert to raise clinical awareness of NLNR allergy issues. FDA has proposed an NLNR labeling regulation, participates in voluntary standards activities for medical gloves, has begun collaborative research on NLNR allergy-related issues, and has cosponsored an international conference on latex sensitivity.

FDA continues to receive many calls from health professionals requesting information on NLNR allergic and anaphylactic incidents. Since FDA began efforts to inform health professionals about such reactions, we have received many reports about problems with various medical devices that contain NLNR.

FDA has received over 1,000 allergic and anaphylactic reaction reports on NLNR patient examination and surgeon's gloves, most of them from health professionals reporting their own reactions. In response, FDA conducted research and published two articles, "Prevalence of Latex-Specific IgE Antibodies in Hospital Personnel"⁽¹⁾ and "Short Analytical Review: Latex-Associated Allergies and Anaphylactic Reactions."⁽²⁾ FDA continues to work with device manufacturers and other Federal agencies responsible for occupational health concerns regarding latex sensitivity. On June 23, 1997, the National Institute for Occupational Safety and Health (NIOSH) released an alert titled "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace." You can obtain copies of this document by calling 1-(800) 356-4674 or by visiting the NIOSH home page at http://www.cdc.gov/niosh/homepage.html.

⁽¹⁾ Kaczmarek, R.G., Silverman, B.G., Gross, T.P., et al., Annals of Allergy, Asthma, and Immunology, 1996; 76: 51-56.

⁽²⁾ Tomazic, V.J., Withrow, T.J., Fisher, B.R., and Dillard, S.F., Clinical Immunology and Immunopathology, 1992; 64 (2): 89-97.

FDA/Website Management Staff