Monday, May. 10, 1948

The Mystery of CM-8164

Glucose in salt solution is as common in hospitals as table salt in kitchen cabinets. Doctors inject it into patients' veins to replace body fluids lost in accidents and operations.

One day last January the Cutter Laboratories in Berkeley, Calif, made a routine shipment to their warehouse in Jacksonville, Fla. of 391 cases of 5% glucose in normal salt solution. All 2,346 bottles bore the laboratory code number CM-8164. Three months later a worried doctor in Hazard, Ky. telegraphed the American Medical Association headquarters in Chicago ; he had noticed alarming reactions in two patients who had been given injections from bottles labeled CM-8164.

The A.M.A. immediately notified the Food & Drug Administration and warned all hospitals. The FDA sent its full force of 230 inspectors to track down the 391 cases of glucose; nearly 800 state and local health officials joined in. By last week all but 49 cases had been located. For some, the warning came too late. Three deaths and a dozen patients with serious reactions (vomiting, diarrhea, low blood pressure, blue skin) were reported, all in the area between Louisville and Miami.

Did the CM-8164 cause the deaths? No one could say for sure; the three patients who died after injections were very ill anyway. The FDA analyzed some of the bottles, found they contained a pyrogenic (fever-causing) substance. When laboratory rabbits were injected with the solution, half died, half got sick.

How did the impurity get into the glucose? Best guess of the Cutter Laboratories: the bottles were jarred in shipment and their rubber stoppers loosened. When the vacuum was broken, air rushed in and bacteria formed a poisonous mold that grew readily in the glucose. Laboratory technicians pointed out that all boxes of glucose they ship contain this warning to doctors: make sure that the vacuum has not been broken, and beware of cloudiness, a sign of contamination.

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