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RRP ISA Survey Results


    1

    Artemisinin Safety and Pharmacokinetics

    Exhausted by the endless rumors, etc., we decided to do a search of our own:

    http://healthtech.who.int/pq/info_applicants/Guidelines/Nonclinical_Overview_Artemisinin-Derivatives.pdf 67 page WHO-related article (World Health Organization of the United Nations), contains some clinical dosing levels and toxicity data--voluminous, well-documented and extremely helpful.

    http://www.townsendletter.com/Dec2002/artemisinin1202.htm (secondary source).

    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
    pubmed&list_uids=8730315&dopt=Citation
    (primary source, dosage for malaria a bit less than our dosing suggestions)

    http://www.blackwell-synergy.com/doi/pdf/10.1046/j.1365-2125.1998.t01-1-00686.x
    Safety study for artemisinin showing it is safe for children as young as 2 years old.

    http://www.google.com/search?q=artemisinin+children&ie=
    utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a

    Google search showing safety indication, including indications in children.

    Anyone using ART with kids needs to work under physician supervision. Close monitoring is absolutely required. RRP ISA is not "recommending" any treatments, including ART, and we are adding a cautionary comment with respect to the use of ART in infants, toddlers and young children who, almost by definition, have very small airways.


    http://tropej.oxfordjournals.org/cgi/content/full/52/2/78
    World Health Organization (WHO) report showing safety in children with minimal side-effects, including neurological, even for analogues of ART.

    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
    PubMed&list_uids=12435450&dopt=Abstract

    At VERY HIGH doses, artemisinin derivatives can be neurotoxic in animal studies, but toxicity has not been found in clinical studies. [Doses we are using are not even many times smaller.]

    http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/95vol21/
    21s3/21s3q_e.html

    Artemisinin derivatives have been used in over 1 million patients and are well tolerated. Neurologic lesions involving the brainstem have been seen in rats, dogs, and more recently in primates [unpublished] given repetitive very high doses of artemether. To date no clinical neurologic events have been observed in humans.

    http://www.rbm.who.int/cmc_upload/0/000/014/923/am2_1-8.htm (primary +secondary)
    There is no clinical evidence to date of serious neurotoxicity resulting from the use of any artemisinin drug in humans in prospective studies of more than 10 000 patients or in the more than 2 million persons who have received these drugs (234, 235).