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Pages 1-16

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From page 1...
... policy requires that service members deployed to malaria-endemic areas be issued antimalarial drugs and adhere to the drug-taking regimens. Policies concerning which should be used as first-line and as second-line agents have evolved over time in response to malaria parasite resistance to antimalarials and new data about the drugs' adverse events and which precautions should be taken for specific underlying health conditions, areas of deployment, and other operational factors.
From page 2...
... The committee was asked to offer conclusions based on available evidence regarding associations of persistent or latent adverse events and to offer observations concerning the best use of available data as well as considerations for future research on the short-term and also the persistent or latent health effects of antimalarial drugs. In conducting its work, the committee operated independently of VA and other government agencies.
From page 3...
... This report provides an evidence-based assessment of the scientific evidence regarding persistent and latent adverse events following the prophylactic use of the six antimalarial drugs of interest for the Secretary of Veterans Affairs to consider as VA exercises its responsibilities to veterans. COMMITTEE'S APPROACH TO ADDRESSING ITS CHARGE The committee's principal source of information on the potential persistent and latent health effects associated with the use of the antimalarials of interest was epidemiologic studies (observational studies and clinical trials)
From page 4...
... . These formed the basis for the committee's conclusions on the relationships between the use of antimalarial drugs and specific categories of persistent adverse health effects.
From page 5...
... These populations use antimalarial drugs but do not have some of the potentially confounding stressors, such as combat, typically found in military populations. Safety and tolerance studies performed in research volunteers from non-endemic areas
From page 6...
... or demographic trait are described when appropriate. Animal and Mechanistic Studies The most commonly used experimental animal models for testing the potential toxicity of antimalarial drugs are mice, rats, dogs, and rhesus monkeys.
From page 7...
... In making its assessments, the committee was careful to note that a lack of informative data does not mean that there is no increased risk of a specific adverse event, only that the available evidence does not provide support for an increased risk. Each conclusion consists of two parts: the first sentence assigns the level of association, and the second sentence offers additional detail regarding whether further research in a particular area is merited based on a consideration of all the available evidence and any signals that may be present.
From page 8...
... There is inadequate or insufficient evidence of an asso ciation between the following antimalarial drugs and health outcomes, grouped by whether the existing evidence supports additional research: Basis for additional research • Mefloquine and neurologic events • Mefloquine and psychiatric events, including PTSD
From page 9...
... However, a change in classification from inadequate or insufficient evidence of an association to limited or suggestive evidence of no association would require new studies that correct for the methodologic problems of previous studies and that have samples large enough to limit the possible study results attributable to chance. None of the associations between the antimalarial drugs and health outcomes were determined to constitute limited or suggestive evidence of no association.
From page 10...
... However, the post-cessation studies did not find these concurrent adverse events to be present at statistically different rates among users of mefloquine than with those who used other antimalarial drugs or who did not use any prophylaxis. Similarly, the evidence supporting concurrent adverse psychiatric effects (anxiety, depression, mood swings, panic attacks, abnormal
From page 11...
... Therefore, based on the available evidence primarily from the epidemiologic ­ tudies, the committee concluded that there is insufficient or s inadequate evidence of an association between the use of mefloquine for malaria prophylaxis and persistent or latent neurologic events or psychiatric events, including PTSD. However, given the concurrent adverse events, case reports, public submissions, and experimental animal studies, the committee concluded that there is a basis for further study of such associations.
From page 12...
... As such, although the committee concluded that there was insufficient or inadequate evidence of an association between the use of tafenoquine for malaria prophylaxis and persistent or latent psychiatric events, it also concluded that there was a basis for further study of persistent or latent psychiatric events. Other Outcomes for Which There Is a Basis for Additional Research The committee also identified several other indications of associations for specific outcomes in its review of post-cessation epidemiologic studies and supporting evidence (such as case reports of persistent adverse events, concurrent adverse events, or biologic plausibility)
From page 13...
... Therefore, a logical place to look for additional opportunities would be in other large databases that include a sufficiently large number of individuals who used antimalarial drugs and that provide documentation of their subsequent health experience; another option would be to link several large databases to obtain the data needed for both exposure and outcome assessment. Such data sources might include general VA and DoD health care databases, existing DoD and VA registries, cohorts of service members or veterans assembled previously, Medicare, FDA Sentinel, commercially available claims databases, and health care data from other countries with national health care systems.
From page 14...
... A number of approaches are unlikely to provide much additional insight regarding the persistent adverse events of antimalarial drugs. These include crosssectional studies that do not allow for distinguishing between the use of a drug and correlates of symptoms or diagnoses; small clinical trials without sufficiently long post-cessation follow-up periods or sufficient numbers of participants to provide the needed statistical precision to address clinically significant outcomes; and studies of reports submitted to adverse event registries, such as that used by FDA.
From page 15...
... Am J Trop Med Hyg 81:356-362.
From page 16...
... 2014. Use of anti-malarial drugs and the risk of developing eye disorders.


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