The Food and Drug Administration has documented at least 16 deaths and 190 nonfatal reactions to latex between last April and mid-January. The reaction reports involve several manufacturers and a broad spectrum of latex products in addition to E-Z-Em's barium enema latex cuff.
As the leading manufacturer of the barium enema used in gastrointestinal imaging, E-Z-Em sells five to six million kits per year. The Westbury, NY, company voluntarily removed the device from the market in October 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 contention that the problem is not isolated to its product. That claim seems borne out by the accumulating reports that involve devices from numerous sources, including condoms and latex gloves.
"They (latex reactions) are not confined to the E-Z-Em product 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 Beaumont Hospital in Royal Oak, MI. Feczko reported the latest FDA figures at a meeting last month of the Society of Gastrointestinal Radiologists in Carlsbad, NM.
The bulk of the FDA data seems to relate to latex but in a few cases, including some upper GI studies, no latex enema tip was involved, Feczko said. Two patients reported skin reactions to barium where it had leaked out.
Latex reactions also appear to be common among health-care workers. About 10% of reported cases involve nurses, nursing assistants, dentists and a few doctors.
CORRECTION:
Reversible binding circumvents potential metabolism problems that may arise for macromolecular-based agents that contain irreversibly attached gadolinium chelates. Metabolism of such conjugates may release the toxic gadolinium ions, according to Dr. Randall B. Lauffer, Metasyn chairman and chief scientific officer.
