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News From the Food and Drug Administration
September 8, 1999

Endotoxin-like Reactions to Gentamicin Sulfate

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JAMA. 1999;282(10):932. doi:10.1001/jama.282.10.932-JFD90007-2-1

Since the start of 1998, FDA and CDC have received approximately 130 reports of endotoxin-like reactions—characterized by fever, rigors, and/or hypotension—following intravenous administration of two brands of gentamicin sulfate. About 70 of the reported cases were temporally associated with once-daily dosage of one product that was voluntarily withdrawn from the market in December. The other product, also voluntarily withdrawn, was associated with more than 60 endotoxin-like reactions reported this year. FDA is investigating these cases.