The Food and Drug Administration has documented at least 16 deathsand 190 nonfatal reactions to latex between last April and mid-January.The reaction reports involve several manufacturers and a broadspectrum of latex products in addition to E-Z-Em's
The Food and Drug Administration has documented at least 16 deathsand 190 nonfatal reactions to latex between last April and mid-January.The reaction reports involve several manufacturers and a broadspectrum of latex products in addition to E-Z-Em's barium enemalatex cuff.
As the leading manufacturer of the barium enema used in gastrointestinalimaging, E-Z-Em sells five to six million kits per year. The Westbury,NY, company voluntarily removed the device from the market inOctober and has replaced it with a nonallergenic silicone version.
Adverse reaction reports have not abated since the recall.The company has remained steadfast, however, in its contentionthat the problem is not isolated to its product. That claim seemsborne out by the accumulating reports that involve devices fromnumerous sources, including condoms and latex gloves.
"They (latex reactions) are not confined to the E-Z-Emproduct at all, but since E-Z-Em controls the (enema cuff) market,they proportionately have more of the reported reactions,"said Dr. Peter J. Feczko, a staff radiologist at the William BeaumontHospital in Royal Oak, MI. Feczko reported the latest FDA figuresat a meeting last month of the Society of Gastrointestinal Radiologistsin Carlsbad, NM.
The bulk of the FDA data seems to relate to latex but in afew cases, including some upper GI studies, no latex enema tipwas involved, Feczko said. Two patients reported skin reactionsto barium where it had leaked out.
Latex reactions also appear to be common among health-careworkers. About 10% of reported cases involve nurses, nursing assistants,dentists and a few doctors.
Reversible binding circumvents potential metabolism problemsthat may arise for macromolecular-based agents that contain irreversiblyattached gadolinium chelates. Metabolism of such conjugates mayrelease the toxic gadolinium ions, according to Dr. Randall B.Lauffer, Metasyn chairman and chief scientific officer.