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Reiter's syndrome as a manifestation of an immune reconstitution syndrome in an HIV-infected patient: successful treatment with doxycycline.

was examined for data on neurological assessments, there was a paucity of available information, especially regarding children. For example, even in the NDA’s primary reference [3] that presented data on neurological examinations in patients treated with artemisinins, it states that “neurological examinations could be performed reliably only in patients 15 years old” (p. 522). The large safety experience is also undermined when counterfeit drugs with subpotent ingredients or no active ingredient are being used [4]. In the formal study results presented at the meeting [2], there was a death that occurred on study. The probable cause of death for the 3-year-old boy was concluded to be iatrogenic water intoxication. Although this etiology was likely, it is worth noting that this boy’s dihydroartemisinin levels shortly before death were 3 times higher than the mean values for similarly aged children. Likewise, in the Artekin study [1], there was 1 death that was thought to have involved a “sepsislike” presentation. Again, although this etiology is most likely, without evidence, for instance, from an autopsy, drug level measurements or blood culture data, there is no definitive way to exclude the possibility of a neurotoxic adverse event associated with drug treatment itself. Because malaria is such a prevalent disease worldwide, the amount of patient exposure to malaria drugs is immense. It is imperative that the pharmacokinetic, safety, and efficacy parameters of the drug be carefully studied before widespread use. This was discussed at the FDA advisory meeting [2], and studies of artesunate by the WHO, with the consultation of the FDA, are in development. Vigilant safety evaluations should be part of any study using artemisinin derivatives, alone or in combination with other compounds.