Westbury, New York: The largest manufacturer of barium enema tips is recalling its latex-containing products because users have experienced serious allergic reactions.

Evidence suggests that water-soluble proteins in latex may trigger deadly reactions.
The Food and Drug Administration is asking physicians to report to the agency any incidents of reactions to the use of barium enema latex tips. Patients can also be helpful by questioning whether such procedures involved latex-containing components.

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AinaM's picture

That's really scary. Maybe many of these products are Unsafe production could derive from low-cost drugs that's why there is a need that we cooperate with the FDA.


Severe allergic reactions in patients undergoing barium enemas prompted the manufacturer last October to voluntarily recall the type of enema tip used in the procedures. The 150 adverse reaction reports included nine deaths.
Up to 10 million barium enema x-ray procedures are performed each year in the United States to diagnose disorders of the lower digestive tract.

The exact cause of the adverse reactions is unclear. The manufacturer, E-Z-Em, Inc., of Westbury, N.Y., asked physicians to stop using enema tips with inflatable latex cuffs. The firm also stated in recall letters to health professionals and purchasers that water-soluble proteins in products with latex may trigger severe allergic reactions, especially in patients who have a history of allergies. The recalled E-Z-Em tips have inflatable cuffs (used to prevent barium leakage from the rectum during the procedure) that contain latex.

Through the October 1990 FDA Drug Bulletin, the agency also alerted U.S. physicians to the problem, requesting reports of allergic reactions to barium enemas or to products containing latex.