NA;Starting in 1989, adverse reaction reports from the United States noted the occurrence of a new systemic reaction, also referred to as ldquo;delayed Jarischhyphen;Herxheimer reaction,rdquo; in patients treated with cefotaxime for Lyme disease. This study was undertaken to investigate whether this reported systemic reaction could be considered a new adverse drug reaction to cefotaxime or expression of the underlying Lyme disease. All spontaneous adverse reaction reports received by Hoechst AG from the United States within the period January 1, 1987, to December 31, 1993, were reviewed. An operational definition of the observed systemic reaction was established, and reports were classified in five categories according to probability of representing a case of the reactioncolon; certain, possible, unlikely, highly unlikely, or excluded. A strong association between Lyme disease as the indication for cefotaxime treatment and the systemic reaction was detectedcolon; 30 lpar;97percnt;rpar; of 31 cases identified as certain were treated for Lyme disease, as opposed to 27 lpar;90percnt;rpar; of 30, 31 lpar;69percnt;rpar; of 45, 65 lpar;39percnt;rpar; of 167, and 42 lpar;11percnt;rpar; of 392 of those identified, respectively, as possible, unlikely, highly unlikely, and excluded lpar;P .001 and significant linear trendrpar;. This suggests that the new reported systemic adverse event may not be due to cefotaxime on its own but that it may represent either a combined effect of the drug and disease or persistent symptoms of the underlying Lyme disease not resolved by antibiotic therapy. The possibility of an effect of long treatment duration of cefotaxime cannot be completely ruled out but remains very unlikely.
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